Conditions: Chronic Obstructive Pulmonary Disorder
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1876
Healthy volunteers: no

Brief summary:
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

Detailed description:
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

Arms:
arm 1: Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID arm 2: Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID arm 3: Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Interventions: intervention 1: BFF MDI (PT009) 320/9.6 μg intervention 2: BFF MDI (PT009) 160/9.6 μg intervention 3: FF MDI (PT005) 9.6 μg
Intervention descriptions: intervention 1: Blinded Treatment intervention 2: Blinded Treatment intervention 3: Blinded Treatment

Protocol document:
Prot_000.pdf: 
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Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018 
(Page 1 of 115) 
STATISTICAL ANALYSIS PLAN FOR
STUDY PT009003
Protocol Number:
PT009003-03
Investigational Drug 
and Drug Number:
BFF MDI; PT009
FF MDI; PT005
Indication:
COPD
Dosage Form/Dose:
BFF MDI 320/9.6 ȝJ%,'
BFF MDI 160/9.6 ȝJ%,'
))0',ȝJ%,'
PT009003 Protocol Title: A Randomized, Double-Blind, Parallel Group, Multi-Center Study to 
Assess the Efficacy and Safety of PT009 Compared to PT005 in Subjects with Moderate to Very 
Severe COPD  
Date of Issue:
09 February 2018
Version:
Version 1.0




Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 3 of 115)
Change Log
Version No.
Effective Date
Reason for the Change / Revision
Supersedes


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 4 of 115)
TABLE OF CONTENTS
1. 
INTRODUCTION .....................................................................................................................................12 
2. 
STUDY OBJECTIVES AND ENDPOINTS............................................................................................12 
2.1 
STUDY OBJECTIVES............................................................................................................................12 
2.1.1 
Primary Objective...............................................................................................................12 
2.1.2 
Secondary Objectives .........................................................................................................12 
2.1.3 
Safety Objectives................................................................................................................12 
2.1.4 
Healthcare Resource Utilization (HCRU) Objective..........................................................12 
2.2 
STUDY ENDPOINTS.............................................................................................................................12 
2.2.1 
Primary Efficacy Endpoints................................................................................................13 
2.2.2 
Secondary Efficacy Endpoints............................................................................................13 
2.2.3 
Other Efficacy Endpoints ...................................................................................................13 
2.2.4 
Safety Endpoints.................................................................................................................15 
2.2.5 
Health Care Resource Utilization Endpoints ......................................................................15 
3. 
STUDY DESIGN AND ANALYTICAL CONSIDERATIONS.............................................................16 
3.1 
STUDY DESIGN...................................................................................................................................16 
3.1.1 
Overall Study Design and Plan...........................................................................................16 
3.1.2 
Prior, Concomitant, Post-Treatment, Prohibited Medications, and Other Restrictions ......18 
3.2 
HYPOTHESIS TESTING ........................................................................................................................18 
3.3 
INTERIM ANALYSIS ............................................................................................................................19 
3.4 
SAMPLE SIZE......................................................................................................................................19 
4. 
DATA AND ANALYTICAL QUALITY ASSURANCE........................................................................21 
5. 
ANALYSIS POPULATIONS ...................................................................................................................21 
5.1 
POPULATION DEFINITIONS .................................................................................................................21 
5.1.1 
Intent-to-Treat (ITT) Population.........................................................................................21 
5.1.2 
Modified Intent-to-Treat (mITT) Population......................................................................21 
5.1.3 
Rescue Ventolin User Population.......................................................................................22 
5.1.4 
Safety Population................................................................................................................22 
5.2 
POPULATIONS FOR PRIMARY AND SENSITIVITY ANALYSES................................................................22 
6. 
STATISTICAL ANALYSIS .....................................................................................................................22 
6.1 
DATA HANDLING RULES AND DEFINITIONS, INCLUDING HANDLING OF MISSING DATA....................23 
6.2 
SUBJECT DISPOSITION AND ANALYSIS POPULATIONS ........................................................................24 
6.3 
DEMOGRAPHIC AND BASELINE CHARACTERISTICS AND EXTENT OF EXPOSURE.................................25 
6.3.1 
Demography, Baseline Characteristics, and CAT ..............................................................25 
6.3.2 
COPD History, Screening/Baseline Spirometry, and Reversibility....................................26 
6.3.3 
Medical and Surgical History at Screening, Reproductive Status and Pregnancy Testing.26 
6.3.4 
Prior, Concomitant, and Post-Treatment Medications/Treatments.....................................27 
6.3.5 
Extent of Exposure to Study Medication and Compliance .................................................28 
6.4 
EFFICACY ANALYSES.........................................................................................................................28 
6.4.1 
Estimands ...........................................................................................................................28 
6.4.2 
Baselines and Baseline Covariates for Analysis.................................................................29 
6.4.3 
Impact of Variable Length of the Study on the Analyses...................................................30 
6.4.4 
Primary Efficacy Analysis..................................................................................................31 
6.4.4.1 
Change from Baseline in Morning Pre-Dose Trough FEV1 ..............................31 
6.4.4.2 
Assumptions Checks and Removal of Outliers in Sensitivity Analyses ............32 
6.4.4.3 
Sensitivity Analyses for Missing Data...............................................................32 
6.4.4.4 
Cumulative Responder Analysis........................................................................34 
6.4.5 
Secondary Efficacy Analyses .............................................................................................35 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 5 of 115)
6.4.5.1 
Time to First Moderate or Severe COPD Exacerbation.....................................35 
6.4.5.2 
Time to First Clinically Important Deterioration ...............................................38 
6.4.5.3 
Transition Dyspnea Index ..................................................................................38 
6.4.5.4 
St. George’s Respiratory Questionnaire.............................................................40 
6.4.5.5 
Rescue Ventolin HFA Use.................................................................................41 
6.4.5.6 
EXACT Total Score...........................................................................................43 
6.4.6 
Other Efficacy Analyses.....................................................................................................44 
6.4.6.1 
Other Spirometry Endpoints ..............................................................................44 
6.4.6.2 
Rate of COPD Exacerbations.............................................................................44 
6.4.6.3 
Time to First COPD Exacerbation of any Severity............................................49 
6.4.6.4 
Time to First Severe COPD Exacerbation .........................................................49 
6.4.6.5 
Time to First COPD Exacerbation Treated with Systemic Steroids ..................50 
6.4.6.6 
Time to First COPD Exacerbation Treated with Antibiotics .............................50 
6.4.6.7 
Time to Treatment Failure .................................................................................50 
6.4.6.8 
Time to Death: All Causes, Respiratory.............................................................50 
6.4.6.9 
Time to First Sustained Clinically Important Deterioration...............................50 
6.4.6.10 European Quality-of-Life-5 Dimension-5 Level Questionnaire (EQ-5D-5L)....51 
6.4.7 
Subgroup Analyses.............................................................................................................52 
6.4.8 
Control of Type I Error.......................................................................................................53 
6.4.8.1 
US Approach......................................................................................................53 
6.4.8.2 
Ex-US Approach................................................................................................55 
6.4.9 
Correlation Analysis...........................................................................................................57 
6.5 
SAFETY ANALYSIS .............................................................................................................................57 
6.5.1 
Adverse Events...................................................................................................................58 
6.5.1.1 
Adverse Events of Special Interest ....................................................................60 
6.5.1.2 
Major Adverse Cardiovascular Event (MACE) Events Determined by Clinical 
Endpoint Committee..........................................................................................62 
6.5.1.3 
Pneumonia Events Determined by Clinical Endpoint Committee .....................62 
6.5.1.4 
Cause of Death Determined by Clinical Endpoint Committees.........................63 
6.5.1.5 
Paradoxical Bronchospasms ..............................................................................63 
6.5.2 
Clinical Laboratory Measurements.....................................................................................63 
6.5.3 
Vital Signs ..........................................................................................................................67 
6.5.4 
12-Lead Electrocardiogram Measurements ........................................................................69 
6.5.5 
Healthcare Resource Utilization.........................................................................................70 
6.5.6 
Physical Examination .........................................................................................................72 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 6 of 115)
7. 
CHANGES FROM METHODS PLANNED IN THE PROTOCOL ....................................................72 
8. 
STATISTICAL SOFTWARE...................................................................................................................73 
9. 
REFERENCES ..........................................................................................................................................73 
APPENDIX 1: DATA HANDLING RULES....................................................................................................75 
APPENDIX 2: ANALYSIS DATASET SPECIFICATIONS..........................................................................83 
APPENDIX 3: SAS CODE FOR STATISTICAL ANALYSES .....................................................................83 
APPENDIX 4: CTCAE LABORATORY TEST CRITERIA FOR SHIFT TABLES AND CENTRAL 
LABORATORY REFERENCE RANGES FOR USE IN FLAGGING ABNORMAL VALUES....83 
APPENDIX 5: STANDARD MEDDRA QUERIES (SMQ)............................................................................83 
APPENDIX 6: STATISTICAL DETAILS .......................................................................................................83 
APPENDIX 7: TABLE OF CONTENTS END-OF-TEXT TLFS ..................................................................84 
APPENDIX 8: EQ-5D CROSSWALK SPSS AND SAS CODE FOR STATISTICAL ANALYSES OF 
INDEX SCORE......................................................................................................................................115 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 7 of 115)
List of Tables
Table 1 
Planned Sample Size..............................................................................................17 
Table 2 
Power Estimates for Morning Pre-Dose Trough FEV1 .........................................19 
Table 3 
Power Estimates for Incidence of Moderate or Severe COPD Exacerbations.......20 
Table 4 
Sensitivity Analyses for Morning Pre-Dose Trough FEV1 ...................................33 
Table 5 
Sensitivity Analyses for Time to First Moderate or Severe COPD Exacerbations36 
Table 6 
Adverse Events of Special Interest ........................................................................60 
Table 7 
Lab Parameters.......................................................................................................64 
Table 8 
Potentially Clinically Significant (PCS) Laboratory Parameter Criteria...............66 
Table 9 
Potentially Clinically Significant Criteria for Systolic and Diastolic Blood 
Pressure Parameters ...............................................................................................68 
Table 10 
Potentially Clinically Significant Criteria for Heart Rate Parameters ...................68 
Table 11 
Analysis Study Time Windows for Vital Signs Assessments................................69 
Table 12 
Criteria for PCS ECG Values.................................................................................70 
List of Figures
Figure 1 
Study Design..........................................................................................................18 
Figure 2  
Overarching Intervals of Moderate-or-Severe (QMS) and Severe (QS) COPD 
Exacerbations.........................................................................................................47 
Figure 3  
Overarching Intervals (I) of Mild-Moderate-or-Severe COPD Exacerbation Events 
Based on e-Diary Symptom Data...........................................................................48 
Figure 4  
Overarching Intervals (QQ) of Mild-Moderate-or-Severe COPD Exacerbation 
Events Incorporating Both CRF Data and e-Diary Symptom Data .......................48 
Figure 5  
Group 1: Type I Error Control for the Analyses of the Primary Endpoints (US 
Approach) ..............................................................................................................54 
Figure 6  
Group 2: The Analysis of the Secondary Endpoints (US Approach) ....................55 
Figure 7 
Group 1: Type I Error Control for the Analyses of the Primary Endpoints (Ex-US 
Approach) ..............................................................................................................56 
Figure 8 
Group 2: The Analysis of the Secondary Endpoints (Ex-US Approach)...............57 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 8 of 115)
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
AE
Adverse Event
AESI
Adverse Event of Special Interest
ALT
Alanine Aminotransferase
ANCOVA
Analysis of Covariance
AR(1)
Autoregressive Order 1
AST
Aspartate Aminotransferase
ATS
American Thoracic Society
BDI
Baseline Dyspnea Index
BFF MDI
Budesonide and Formoterol Fumarate Metered Dose Inhaler
BID
Bis In Die, Twice Daily
bpm
Beats Per Minute
BMI
Body Mass Index
CAT
Chronic Obstructive Pulmonary Disease Assessment Test
CCU
Coronary Care Unit
CCV
Cardio- and Cerebrovascular
CD
Compact Disc
CI
Confidence Interval
CID
Clinically Important Deterioration
CKD-EPI
Chronic Kidney Disease Epidemiology Collaboration Equation (according 
to National Kidney Disease Education Program)
COPD
Chronic Obstructive Pulmonary Disease
CRF
Case Report Form
CSR
Clinical Study Report
CTCAE
Common Terminology Criteria for Adverse Events
DMC
Data Monitoring Committee
E-RS
Evaluating Respiratory Symptoms
ECG
Electrocardiogram


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 9 of 115)
eCRF
Electronic Case Report Form
eDiary
Electronic Diary
e.g.
Exempli Gratia, For Example
eGFR
Estimated glomerular filtration rate
EOS
Eosinophil
EOT
End of Treatment
ERS
European Respiratory Society
EQ-5D
EuroQol 5 Dimensions Questionnaire
EQ-5D-5L
EuroQol 5 Dimensions Questionnaire 5-level 
ER
Emergency Room
EXACT
Exacerbations of Chronic Pulmonary Disease Tool – Patient Reported 
Outcomes
FEV1
Forced Expiratory Volume in 1 Second
FEF25-75
Forced Expiratory Flow between 25% and 75% of FVC
FF
Formoterol Fumarate
FVC
Forced Vital Capacity
H0
Null Hypothesis
H1
Alternative Hypothesis
hCG
Human Chorionic Gonadotropin
HCRU
Health Care Resource Utilization
HFA
Hydrofluoroalkane
HLGT
High Level Group Term
HLT
High Level Term
ICF
Informed Consent Form
ICS
Inhaled Corticosteroid
ICU
Intensive Care Unit
ID
Identification
i.e.
Id Est, That Is


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 10 of 115)
ITT
Intent-to-Treat
L
Liter
LABA
Long-$FWLQJȕ2-Agonist
LAMA
Long-Acting Muscarinic Antagonist
MACE
Major Adverse Cardiovascular Event
MAR
Missing at Random
MCAR
Missing Completely at Random
MCMC
Markov Chain Monte Carlo
MCID
Minimal Clinically Important Difference
MDI
Metered Dose Inhaler
MedDRA
Medical Dictionary for Regulatory Activities
MI
Multiple Imputation
μg
Microgram
mITT
Modified Intent-to-Treat 
mL
Milliliter
mm
Millimeter
mmHg
Millimeter of Mercury
MNAR
Missing Not at Random
msec (ms)
Millisecond
NHANES III
Third National Health and Nutrition Examination Survey
OTC
Over-the-Counter
PCS
Potentially Clinically Significant
PEFR
Peak Expiratory Flow Rate
PIN
Personal Identification Number
PFT
Pulmonary Function Test
PMM
Pattern-Mixture Model 
PT
Preferred Term
PT005
Formoterol Fumarate Inhalation Aerosol


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 11 of 115)
PT009
Budesonide and Formoterol Fumarate Inhalation Aerosol
QoL
Quality of life
QTcF
QT Corrected Using Fridericia’s Formula
RM
Repeated Measures
ROM
Read-Only Memory
RVU
Rescue Ventolin User
SABA
Short-$FWLQJȕ2-Agonist
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SD
Standard Deviation
SGRQ
St. George’s Respiratory Questionnaire
SMQ
Standard MedDRA Query
TC
Telephone Call
TDI
Transition Dyspnea Index
TEAE
Treatment-Emergent Adverse Event
ULN
Upper Limit of Normal
US
United States
VAS
Visual Analog Scale
Trademark Information
Trademarks Not Owned By Pearl
SAS® software
Ventolin®


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 12 of 115)
1.
INTRODUCTION
This Statistical Analysis Plan (SAP) outlines the statistical methods for the display, summary and 
analysis of data to be performed at the end of Pearl Therapeutics, Inc. (Pearl) Study PT009003. 
The SAP should be read in conjunction with the study protocol. This version of the SAP has 
been developed using the PT009003-03 Amended Protocol (Version 4.0 dated 08 January 2018)
and the PT009003 case report form (CRF) (Revision 03 dated 04 May 2017).
2.
STUDY OBJECTIVES AND ENDPOINTS
2.1
Study Objectives
The overall objective is to assess the efficacy and safety of treatment with BFF MDI 320/9.6 ȝJ
(budesonide and formoterol fumarate metered dose inhaler), BFF MDI 160/9.6 ȝJDQG))0',
9.6 ȝJformoterol fumarate metered dose inhaler) administered twice daily (BID) over a 
minimum of 12 weeks and a maximum of 52 weeks in subjects with moderate to very severe 
chronic obstructive pulmonary disease (COPD).
Primary Objective
2.1.1
x
To assess the effects of BFF MDI relative to FF MDI on lung function
Secondary Objectives
2.1.2
x
To assess the effects of BFF MDI relative to FF MDI on COPD exacerbations
x
To assess the effects of BFF MDI relative to FF MDI on symptoms of COPD
x
To assess the effects of BFF MDI relative to FF MDI on quality of life (QoL)
Safety Objectives
2.1.3
x
To assess the safety of BFF MDI and FF MDI
Healthcare Resource Utilization (HCRU) Objective
2.1.4
x
To assess overall and COPD-specific HCRU of BFF MDI and FF MDI
2.2
Study Endpoints
The primary endpoints, treatment comparisons of interest, and analysis timeframes may differ by 
country or region due to local regulatory agency requirements. The Sponsor has defined two different 
registration approaches in this study. The registration approaches will be called: (1) United States 
(US) and (2) Ex-US. The US approach is for countries or regions such as the United States where the 
primary and secondary endpoints are generally evaluated at a point in time. The Ex-US approach is 
for registration purposes in countries or regions such as Europe where the primary and secondary 
endpoints are generally evaluated over a period of time. The multiplicity controls for the primary and 
secondary efficacy analyses are delineated in section 6.4.8.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 13 of 115)
Note that spirometry endpoints are generally evaluated relative to baseline; thus, change from 
baseline is always implied for these endpoints.
Primary Efficacy Endpoints 
2.2.1
US APPROACH
x
Morning pre-dose trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Ex-US APPROACH
x
Morning pre-dose trough FEV1 over 24 weeks
Secondary Efficacy Endpoints
2.2.2
US APPROACH
x
Time to first moderate or severe COPD exacerbation
x
Change from baseline in average daily rescue Ventolin Hydrofluoroalkane (HFA) use over 12 
weeks
x
Percentage of subjects achieving a Minimal Clinically Important Difference (MCID) of 4 units or 
more in Saint George’s Respiratory Questionnaire (SGRQ) total score at Week 12
Ex-US APPROACH
x
Time to first moderate or severe COPD exacerbation
x
Time to first clinically important deterioration (CID) in COPD
x
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
x
Percentage of subjects achieving an MCID of 4 units or more in SGRQ total score over 24 
weeks
x
Change from baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) 
total score over the treatment period
x
Transient Dyspnea Index (TDI) focal score over 24 weeks
In both regulatory approaches, morning pre-dose trough FEV1 for the attributable estimand will 
be considered a secondary analysis.  Time to first moderate or severe COPD exacerbation in the 
subgroup of patients with a COPD exacerbation history of at least two moderate or severe 
exacerbations in the previous 12 months will also be considered a secondary analysis.  Both 
analyses will be included in the Type I error control strategy as described in Section 6.4.8.
Other Efficacy Endpoints
2.2.3
Unless already categorized as a secondary endpoint in one of the regulatory approaches above, 
all of the following endpoints will be categorized as “Other efficacy endpoints”.
x
Rate of moderate or severe COPD exacerbations over the treatment period


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 14 of 115)
x
Change from baseline in morning pre-dose trough FEV1, forced vital capacity (FVC), peak 
expiratory flow rate (PEFR), and forced expiratory flow between 25% and 75% of FVC 
(FEF25-75) over 12, 24 and 52 weeks, and at each post-randomization in-clinic visit
x
Rate of COPD exacerbations of any severity
x
Time to first COPD exacerbation of any severity
x
Rate of severe COPD exacerbations
x
Time to first severe COPD exacerbation
x
Rate of COPD exacerbations treated with systemic steroids
x
Rate of COPD exacerbations treated with antibiotics
x
Time to first COPD exacerbation treated with systemic steroids
x
Time to first COPD exacerbation treated with antibiotics
x
Time to first CID in COPD
x
Time to first sustained CID in COPD
x
Time to treatment failure (treatment discontinuation for any cause, moderate or severe 
exacerbation, or death)
x
Time to death, all cause
x
Time to death, respiratory
x
Change from baseline in Exacerbations of Chronic Pulmonary Disease Tool (EXACT) total
score, Evaluating Respiratory Symptoms in COPD (E-RS: COPD) total score (RS-Total 
Score), and symptom domain scores for breathlessness, cough and sputum, and chest 
symptoms over 24 weeks and 52 weeks, and over each 4-week interval of the 52-week 
treatment period
x
Change from baseline in average daily rescue Ventolin HFA use over 12, 24, and 52 weeks 
and over each 4-week interval of the 52-week period
x
Percentage of days with “no rescue Ventolin HFA use”
x
TDI focal score over 12, 24 and 52 weeks, and at each post-randomization in-clinic visit
x
Individual components of the TDI (functional impairment, magnitude of task, and magnitude 
of effort) over 12, 24 and 52 weeks, and at each post-randomization visit
x
Percentage of subjects achieving an MCID threshold of 1 unit or more on average in TDI 
focal score over 12, 24 and 52 weeks 
x
Change from baseline in SGRQ total score over 12, 24 and 52 weeks, and at each post-
randomization in-clinic visit
x
Change in individual domains of the SGRQ (Symptoms, Activity, and Impacts) over 12, 24 
and 52 weeks, and at each post-randomization in-clinic visit
x
Percentage of subjects achieving an MCID of 4 units or more on average in SGRQ total score 
over 12, 24, and 52 weeks, and at each post-randomization in-clinic visit


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 15 of 115)
x
EuroQoL (EQ-5D) Dimensions Questionnaire (EQ-5D-5L) variables including the EQ-5D 
index score, the EQ-5D Visual Analog Score (VAS), and five dimension single item 5-level 
responses at each post-randomization in-clinic visit
Safety Endpoints
2.2.4
The safety endpoints for this study include:
x
Adverse events (AEs), Treatment-emergent AEs, serious AEs (SAEs), AEs of Special 
Interest (AESIs)
x
12-lead electrocardiograms (ECGs)
x
Clinical laboratory values (hematology and clinical chemistry)
x
Vital signs measurements (blood pressure and heart rate)
Health Care Resource Utilization Endpoints
2.2.5
x
The number of days missed from work due to COPD
x
The number of days that primary caregivers of subjects missed from work as a result of the 
subject’s COPD
x
The percentage of subjects with telephone calls to health-care providers
o
Calls to any health-care provider (physician or other)
o
Calls to physician
o
Calls to other health-care provider
x
The mean number of telephone calls to health-care providers
o
Calls to any health-care provider (physician or other)
o
Calls to physician
o
Calls to other health-care provider
x
The percentage of subjects with visits to health-care providers
o
Visits to any health-care provider (general practitioner [GP], specialist, or other)
o
Visits to GP
o
Visits to specialist
o
Visits to other health-care provider
x
The mean number of visits to health-care providers
o
Visits to any health-care provider (GP, specialist, or other)
o
Visits to GP
o
Visits to specialist
o
Visits to other health-care provider


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 16 of 115)
x
The percentage of subjects with Emergency Room (ER) visits
x
The mean number of visits to ERs
x
The percentage of subjects hospitalized
x
The mean number of subject hospitalizations
x
The mean number of days in the hospital
x
The mean number of hospitalizations in which subjects spent some time in the Intensive Care 
Unit (ICU) or the Coronary Care Unit (CCU)
x
The percentage of subjects hospitalized with some time spent in the ICU or CCU
x
The mean number of days in the hospital with some time spent in the ICU or CCU
x
The mean number of hospitalizations in which subjects spent no time in the ICU or CCU
x
The percentage of subjects hospitalized with no time spent in the ICU or CCU
x
The mean number of days in the hospital with no time spent in the ICU or CCU
x
The mean number of days in the ICU
x
The percentage of subjects in the ICU
x
The mean number of days in the CCU
x
The percentage of subjects in the CCU
x
The percentage of subjects who required ambulance transport
x
The mean number of times ambulance transport was required
3.
STUDY DESIGN AND ANALYTICAL CONSIDERATIONS
3.1
Study Design
Overall Study Design and Plan
3.1.1
This is a Phase III, multi-center, randomized, double-blind, parallel-group, variable length 
efficacy and safety study comparing BFF MDI (320/9.6 μg and 160/9.6 μg) to FF MDI 9.6 μg
administered BID, in subjects with moderate to very severe COPD. Eligible subjects must have 
at least 1 moderate or severe COPD exacerbation in the previous 12 months, and remain 
symptomatic, as measured by the COPD Assessment Test (CAT), while receiving one of more 
inhaled maintenance bronchodilators.
Subjects meeting inclusion criteria and no exclusion criteria will be randomized into this study. 
5DQGRPL]DWLRQZLOOEHVWUDWLILHGE\H[DFHUEDWLRQKLVWRU\RUPRGHUDWHRUVHYHUH
exacerbations), post-bronchodilator FEV1 (< 25% to < 50% predicted or 50% to < 80% 
predicted, measured at Visit 2), blood eosinophil (EOS) count RUFHOOVSHUPP3),
and country. Enrollment will be targeted to achieve a 2:1 ratio for the blood eosinophil strata 
ZLWKWZLFHDVPDQ\UDQGRPL]HGVXEMHFWVLQWKHFHOOVSer mm3 category.
Following randomization, subjects will enter the Randomized Treatment Period. The study is 
variable in length, with a planned minimum of 12 weeks and a maximum of 52 weeks on 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 17 of 115)
randomized treatment. The study will end when the last remaining randomized subject completes 
12 weeks on randomized treatment or completes the Final Study Visit. The End of Study is 
defined as the date on which data are collected for the last subject’s Follow-up Telephone Call.
This study will be conducted at approximately 275 sites, contributing approximately 6 to 10 
subjects per site. A total of 1860 subjects will be randomized in a 1:1:1 scheme to one of the 
three treatment groups (see Table 1):
x
BFF MDI 320/9.6 μg BID (620 subjects)
x
BFF MDI 160/9.6 μg BID (620 subjects)
x
FF MDI 9.6 μg BID (620 subjects)
Approximately 1581 subjects are expected to complete the study on randomized treatment to 
Week 12.
Table 1
Planned Sample Size
BFF MDI 
320/9.6 μg
BFF MDI 
160/9.6 μg
FF MDI 
9.6 μg
Overall
Allocation Ratio
1
1
1
Randomized Subjects
620
620
620
1860
Subjects Completing the Study on 
Randomized Treatment to Week 12
527
527
527
1581
Subjects who discontinue randomized treatment prior to end of study will be encouraged to 
remain in the study to complete all remaining study visits. Subjects who agree to continue to be 
followed post treatment discontinuation will sign an informed consent form (ICF) addendum. All 
subjects who agree to continue study participation beyond treatment discontinuation will 
complete a Treatment Discontinuation/Study Withdrawal Visit prior to transitioning back to 
regularly scheduled study visits. Treatment discontinuation subjects will return to appropriate 
maintenance COPD medications, per the Investigator’s discretion. For subjects recorded as 
Treatment Discontinuations that do not complete at least one post-treatment data collection, a 
telephone follow-up call is required at least 14 days after last study drug dose. All AEs/SAEs 
will be collected through the14 day follow up telephone call.
If a subject chooses not to continue with study assessments, at a minimum the subject will 
complete the Treatment Discontinuation/Withdrawal Visit (refer to the Schedule of Events in the 
Study Protocol). These subjects will return to appropriate maintenance COPD medications, per 
the Investigator’s discretion. A follow-up telephone call will be performed at least 14 days after 
the last study drug dose. All AEs/SAEs will be collected through the 14 day follow up telephone 
call. In the event the Treatment Discontinuation/Withdrawal Visit is performed >14 days post 
last study drug dosing, a follow-up telephone call (TC) will not be required. These subjects will 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 18 of 115)
be followed for vital status within 4 to 6 weeks after the last subject has been randomized into 
the study in accordance with the informed consent.
The Schedules of Events and Timed Assessments are in the study protocol.
The overall study design is summarized and illustrated in Figure 1.
Figure 1
Study Design
Prior, Concomitant, Post-Treatment, Prohibited Medications, and Other 
3.1.2
Restrictions
All prescription and over-the-counter (OTC) medications, as well as any herbal or vitamin 
supplements taken by the subject within 30 days before Visit 1 (Screening) will be recorded on 
the Prior/Concomitant Medications electronic Case Report Form (eCRF) with indication, total 
daily dose, dose regimen, and dates of drug administration. Refer to the Protocol for information 
about prohibited medications and other restrictions.
3.2
Hypothesis Testing
For the primary comparisons, the general null hypothesis will be that the mean treatment 
difference between BFF MDI and FF MDI is zero (mean treatment effects are equal). The 
alternative two-sided hypothesis is that the mean treatment difference is greater or less than zero
(mean treatment effects are not equal).


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 19 of 115)
The primary null (H0) and alternative (H1) hypotheses, with μ representing the mean, are 
presented below. The superiority hypotheses will take the following forms:
x
H0: μBFF 320/9.6 = μFF 9.6
H1: μBFF 320/9.6 FF 9.6
x
H0: μBFF 160/9.6 = μFF 9.6
H1: μBFF 160/9.6 μFF 9.6
Two-sided P-value and 95% confidence interval (CI) for μBFF - μFF will be computed.
3.3
Interim Analysis
No interim efficacy analyses are planned for this study.
The Data Monitoring Committee (DMC) will review safety data approximately every 6 months. 
Further detail is given in the DMC Charter.
3.4
Sample Size
It is estimated that a sample size of 1860 subjects (620 per arm in the BFF MDI and FF MDI 
groups) will provide power estimates for morning pre-dose trough FEV1 as summarized in Table 
2, and the power of detecting a numerical trend in the analysis of time to first moderate or severe 
COPD exacerbation as outlined in Table 3.
For morning pre-dose trough FEV1, assumptions regarding variability are based on Pearl’s 
experience with Phase IIb and III clinical studies. The expected standard deviation (SD) for the 
change from baseline at each visit is 200 mL. The expected SD over 24 weeks is 158 mL with a 
correlation of 0.55 over the six post-randomization visits to Week 24.
For the analysis of morning pre-dose trough FEV1 at Week 12 (the US Approach), the proposed 
sample size of 1,860 subjects with 15% drop-out will provide approximately 90% power to 
detect a difference of 40 mL between BFF MDI and FF MDI. The Type I error will be controlled 
at a two-sided alpha level of 0.05.
For the analysis of morning pre-dose trough FEV1 over 24 weeks (the ex-US Approach) with 
30% dropout, the same proposed sample size will provide approximately 96% power to detect a 
difference of 40 mL between BFF MDI and FF MDI. The Type I error will be controlled at a 
two-sided alpha level of 0.05.
Table 2
Power Estimates for Morning Pre-Dose Trough FEV1
Endpoint
Parameter
At Week 12
(US)
Over 24 Weeks
(Ex-US)


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 20 of 115)
Change from Baseline in 
Morning Pre-dose Trough 
FEV1
Assumed Difference 
(BFF – FF)
40 mL
40 mL
Assumed Standard 
Deviation for the 
Difference
200 mL
158 mL
Assumed Correlation 
over the Six Post-
randomization Visits to 
Week 24
-
0.55
Dropout Rate
15%
30%
Power
90%
96%
Assumptions regarding the numerical trend for the observed hazard ratio (HR) between BFF 
MDI and FF MDI are based on a literature review and data from a recent COPD exacerbation 
study of a budesonide and formoterol fumarate combination therapy. The percentage of subjects 
ZLWKDWOHDVWRQHPRGHUDWHRUVHYHUH&23'H[DFHUEDWLRQLQWKH%))0',ȝJDQG))
0',ȝJJURXSVLVHVWLPDWHGWREHDQGUHVSHFWively. This represents a hazard 
ratio of approximately 80% for BFF MDI compared to FF MDI. The projected numbers of 
subjects with at least one moderate or severe COPD exacerbation in this variable length study are 
195 and 234, respectively, for the BFF MDI ȝJDQG))0',ȝJJURXSV7KLVZRXOG
provide 64% power to detect an HR of 80% or lower. The probability of detecting a numerical 
trend in the analysis of time to first moderate or severe COPD exacerbation is estimated to be 
87%, where numerical trend is defined as the observed HR between a BFF MDI dose and FF 
MDI being below 0.90. If the criterion for numerical trend is raised to 0.95, the probability of 
detecting a numerical trend is estimated to be 94%. All calculations assume Type I error control 
at a 2-sided alpha level of 0.05.
Table 3
Power Estimates for Incidence of Moderate or Severe COPD Exacerbations
Endpoint
Parameter
Over the Treatment Period
Time to first 
Moderate-Severe 
COPD Exacerbation
Assumed BFF MDI COPD
Exacerbations incidence
28.3% of subjects
Assumed FF MDI COPD 
Exacerbations incidence
34.0% of subjects
Assumed Hazard Ratio (BFF/FF)
0.8
Power
64%


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018 
(Page 21 of 115) 
Probability to detect numerical trend: 
HVWLPDWHG+5
87%
Probability to detect numerical trend: 
HVWLPDWHG+5
94%
4.
DATA AND ANALYTICAL QUALITY ASSURANCE
The overall quality assurance procedures for the study data, statistical programming and analyses 
are described in Standard Operating Procedures (SOPs) of 
. Detailed 
data management procedures are documented in the study Data Management Plan, Data 
Validation Check Specifications, and Integrated Safety Data Review Plan. Detailed statistical 
and programming quality control and quality assurance procedures are documented in the 
Statistical Analysis and Programming QC/QA Plan.
Transfer of Pulmonary Function Test (PFT) data from the central PFT laboratory
will be defined in the 
 DMP (Data 
Management Plan), and data handling rules related to this data are included in Appendix 1 of this 
SAP. The quality of all PFT’s obtained at each time point will be graded independently at 
by qualified personnel. Quality grading assessments will be based on American 
Thoracic Society/European Respiratory Society (ATS/ERS) criteria and will be included in data 
transfers.
5.
ANALYSIS POPULATIONS
5.1
Population Definitions
Intent-to-Treat (ITT) Population
5.1.1
The Intent-To-Treat Population is defined as all subjects who are randomized to treatment and 
receive any amount of the study treatment. Subjects will be analyzed according to the treatment 
they were assigned at randomization. Data obtained after discontinuation of treatment, but prior 
to withdrawal from the study, will be included. The ITT population will be used for sensitivity 
analyses.
Modified Intent-to-Treat (mITT) Population  
5.1.2
The Modified Intent-to-Treat Population is a subset of the ITT Population, defined as all 
subjects with post-randomization data obtained prior to discontinuation from treatment. Any data 
collected after completion of or discontinuation from randomized study medication will be 
excluded. Subjects will be analyzed according to randomized treatment group. (Note that a 
subject who used a study treatment, but took less than one full dose of treatment will qualify for 
this population). The mITT Population will be the primary population for all efficacy analyses. 
Note: The knowledge that a subject did not have a COPD exacerbation constitutes an efficacy 
assessment.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 22 of 115)
Rescue Ventolin User Population
5.1.3
Differences in rescue Ventolin HFA usage are expected across the study including some subjects 
who used virtually no rescue medication at study entry. In order to represent the population of 
patients who may benefit from study treatment and reduce their use of rescue medication, the 
Rescue Ventolin User (RVU) Population is defined as all subjects in the ITT Population with 
DYHUDJHEDVHOLQH5HVFXH9HQWROLQXVHRISXIf/day. 
Safety Population
5.1.4
The Safety Population is defined as all subjects who are randomized to treatment and receive at 
least one dose of the study treatment. Subjects will be analyzed according to treatment received 
rather than randomized. If a subject received more than one randomized treatment, they will be 
analyzed and included in summaries according to the treatment they received the most. Subjects 
receiving no study treatment will be excluded, as will subjects who have no post-dose safety 
assessments. A subject who used a study treatment, but took less than one full dose of treatment 
will qualify for this population. Note: The statement that a subject had no AEs also constitutes a 
safety assessment.
5.2
Populations for Primary and Sensitivity Analyses
Demographics will be summarized for the mITT, RVU, Safety, and Non-Randomized 
Populations.
Extent of exposure will be summarized for the Safety Population. The Safety Population will be 
used to summarize safety..
Efficacy analyses will be performed for the ITT and mITT Populations.  In general, the mITT 
Population will be considered the primary population for the efficacy analyses, with the ITT 
population being considered supportive. Rescue medication endpoints will be analyzed with 
mITT, ITT, and RVU populations.
A Per Protocol population is not defined in this study. However, important protocol deviations 
will be identified according to the Statistical Protocol Deviation Plan (sPDP) and blinded data
review meeting (BDRM) process. These deviations will be summarized (Table 1.3.1) and listed 
(Listing 1.6.2).
6.
STATISTICAL ANALYSIS
Analyses will be performed when the final database is available. All data collected contributing 
to the analysis will be provided in listings. Data for all subjects who are randomized will be 
included in the subject data listings. Data for non-randomized subjects will be listed where 
available.
All safety and efficacy parameters will be summarized by treatment unless specified otherwise.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 23 of 115)
Continuous variables will be summarized with descriptive statistics (the number of non-missing 
values, mean, standard deviation, median, minimum, and maximum). Additionally, the 25th and 
75th percentiles will be presented when appropriate based on historical knowledge of the 
normality or non-normality distribution of underlying data.
Categorical variables will be summarized with frequency counts and percentages (where 
appropriate).
6.1
Data Handling Rules and Definitions, Including Handling of Missing Data
Missing data will be maintained as missing in the analysis datasets, unless specified otherwise. 
For variables where missing data are imputed, the analysis dataset will contain a new variable 
with the imputed value and the original variable value will be maintained as missing.
Data Imputation for Adverse Events Summaries by Severity and Relationship to Study Drug
For the AE summaries by severity (mild, moderate, or severe), an AE with missing severity will 
be deemed as severe. For the AE summaries by relationship to study drug, an AE with a missing 
relationship to study drug will be deemed as related. Imputed values will not be listed in data 
listings.
Use of Data from Unscheduled Assessments for Laboratory, Vital Sign, and ECG Summaries 
(Continuous Parameters)
Data from unscheduled visits will not be used for by-visit summaries. Data from both scheduled 
and unscheduled visits will be used for shift tables and for determining incidence of clinically
significant values.
Data Imputation (All Laboratory Summaries)
Laboratory values of ‘>=x’ or ‘<=x’ will be taken as the value of x in the analyses. If a 
laboratory value is prefixed with‘>’: the available original value +0.001 will be used for table 
summaries; if a laboratory value is prefixed with ‘<’, then the original value –0.001 will be used 
in table summaries.
Study Dates and Day of Assessment or Event
Study Day and Day of Assessment or Event definitions are provided in Appendix 1, Data 
Handling Rules.
Pre-dose spirometry values will use the average of the non-missing -60 minutes and -30 minutes 
values. Weekly averages for eDiary-based (where eDiary means electronic diary) parameters will 
use all non-missing values.
On-treatment COPD exacerbations


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 24 of 115)
An exacerbation will be considered “on-treatment” if its start date is before or on the last 
treatment date. For treatment discontinuations, this definition is extended to include 
exacerbations starting one day after the last treatment date. (If it is decided during a clinic visit to 
discontinue study drug and to switch to a treatment for the ongoing exacerbation symptoms, the 
subject typically would not take the morning dose of study drug at that visit, and their 
exacerbation start date will be one day after the last treatment date. Such exacerbations will still 
be considered “on-treatment”).
6.2
Subject Disposition and Analysis Populations
Disposition for all randomized subjects will be tabulated (Table 1.1.1) and listed (Listing 1.2). 
The tabulation will include the number of subjects in each randomized treatment who were not 
treated, who received the study treatment, who discontinued treatment prematurely, who 
withdrew from the study prematurely, and who completed the study. The number and percentage 
of randomized subjects included in the mITT, ITT, Rescue Ventolin User, and Safety 
Populations will also be tabulated (Table 1.1.1). Informed consent is listed in Listing 9.6.
The numbers of subjects randomized and in the analysis populations will be provided by country, 
center, and treatment in Table 1.1.2. The number of subjects randomized by stratification factor 
based upon clinical data will be tabulated in Table 1.1.4. The duration of treatment and study 
participation per subject will be summarized in Table 1.1.5. If there are any subjects who took 
study treatment other than what was randomized during the study, both the treatment assigned at 
randomization and actual treatment(s) received during the Treatment Period will be listed 
(Listing 1.3). The duration of actual treatment and duration of study participation will also be 
listed (Listing 1.3). A list of subjects with discrepant IWRS-based and actual stratification factors 
will also be provided (Listing 1.7).
A summary of reasons subjects were not randomized will be provided for all subjects not 
randomized (Table 1.1.3). A listing of reasons subjects were not randomized will also be 
provided (Listing 1.4). Subjects excluded from the ITT, mITT, RVU, and Safety analysis 
populations will be listed (Listing 1.6.1) for all subjects randomized. Reasons for premature 
discontinuation from study treatment will be summarized for the Safety Population (Table 1.2.1). 
Similarly, reasons for subjects’ withdrawal from the study will be summarized for the ITT 
Population (Table 1.2.2).
Time to discontinuation of treatment and withdrawal from the study will be presented 
graphically by means of the Kaplan-Meier plots (Tables and Figures 1.2.3 and 1.2.4).
Important protocol deviations will be listed and summarized for all subjects randomized 
(Table 1.3.1 and Listing 1.6.2). A listing of subjects who did not comply with restrictions on 
smoking, use of rescue medication, and xanthine-containing products prior to spirometry 
(Section 5.1.4.1) will be provided in Listing 6.1.1. Use of rescue medication at pre-dose or 
during the post-dose assessments on each specific test day (yes/no) will be tabulated in 
Listing 6.1.3. In addition, the eligibility information (inclusion/exclusion criteria with any 
waivers granted) of all subjects who are randomized will be listed (Listing 2.1).


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 25 of 115)
The number and percentage of subjects with changes in smoking status after the start of study 
treatment will be tabulated by randomized treatment, by visit and overall during the study in 
Table 1.13 (Safety Population) and listed (Listing 1.5).
6.3
Demographic and Baseline Characteristics and Extent of Exposure
The definitions for the derived demographic or baseline characteristic variables can be found in 
Appendix 1.
Demography, Baseline Characteristics, and CAT
6.3.1
Subject demographics, total CAT score, use of inhaled corticosteroids (ICS) at screening, and 
smoking status/history will be summarized for the mITT, RVU, and Safety Populations and for 
Non-Randomized subjects (Tables 1.4.1 to 1.4.4, respectively, and Listing 1.2). The ITT 
population does not need to be tabulated because it is the same as the mITT population for 
demographics and baseline characteristics. If the Safety Population has the same treatment 
assignment as the mITT, then these summaries will be identical as well and hence not produced. 
Inhaled corticosteroid use (yes/no) will be summarized for all populations except for the Non-
Randomized subjects.
Demographic and baseline characteristic variables summarized will include the following:
x
Age
x
Age Group
x
Age of onset of COPD
x
Gender
x
Race
x
Ethnicity (Hispanic or Non-Hispanic)
x
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0LVVLQJ
x
Used inhaled corticosteroids at Screening (all populations except for Non-Randomized 
subjects)
x
Baseline eosinophil count (<150 cells per mm3 YVFHOOVSHUPP3)
x
%DVHOLQHH[DFHUEDWLRQKLVWRU\JURXSDVDQG06&23'H[DFHUEDWLRQVLQWKHSUHYLRXV
12  months)
x
Smoking status (current vs. former smoker)
x
Number of years smoked
x
Average number of cigarettes smoked per day
x
Number of pack years smoked, calculated as (number of cigarettes per day/20) x number of 
years smoked
x
Weight
x
Height
x
Body mass index (BMI)
Screening and pre-treatment CAT data will be listed (Listing 4.2).


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 26 of 115)
COPD History, Screening/Baseline Spirometry, and Reversibility
6.3.2
Duration of COPD: the number of years prior to the start of study medication that COPD was 
first diagnosed (calculated as [Date of First Dose of Study treatment in the study – Date COPD 
First Diagnosed] /365.25) will be summarized by treatment and all subjects for the mITT and 
Safety Populations and listed (Tables 1.5.1, 1.5.2 and Listing 4.1). The summary for the Safety 
Population will only be presented if it is different from the mITT/ITT Population summary. 
Severity of COPD at Screening Visit 2 post-Ventolin HFA will also be included in these 
summaries. History of moderate or severe COPD exacerbations within the past 12 months will 
be summarized and listed for subjects in the mITT and Safety Populations (Table 1.9.1, 1.9.2, 
and Listing 4.3).
Descriptive statistics will be provided for screening period pre-bronchodilator and post-
bronchodilator and baseline spirometry parameters (Tables 1.6.1 to 1.6.2 for the mITT and RVU 
Populations, respectively, and Listing 2.2).
Characterization of Reversibility:
Reversibility to Ventolin HFA will be evaluated at Visit 2 and used as a stratification variable at 
randomization to ensure an even distribution of reversibility across the treatment arms. A subject 
is considered reversible if the improvement in FEV1 at 30 minutes post-9HQWROLQLVDQG
200 mL.
Reversibility to Ventolin HFA at Screening Visit 2 will be summarized for the mITT Population 
and listed (Table 1.7.1, Listing 2.2 and Listing 5.2 for Ventolin HFA dispensing). The number 
and percentage of subjects reversible will be included in these summaries. Also included will be 
a summary of the change in FEV1 from pre-dose FEV1 to post-bronchodilator assessment. If 
multiple time points are available post-bronchodilator, then the one with the highest FEV1 will 
be used.
Additionally, the number and percentage of subjects meeting each of the following response 
criteria will be summarized for Ventolin HFA bronchodilator:
LPSURYHPHQWSRVW-bronchodilator in FEV1 from pre-bronchodilator
 mL improvement post-bronchodilator in FEV1 from pre-bronchodilator
 mL improvement post-bronchodilator in FEV1 from pre-bronchodilator
Medical and Surgical History at Screening, Reproductive Status and Pregnancy 
6.3.3
Testing
Medical and Surgical History at Screening will be summarized for the Safety Population and 
listed for all randomized subjects (Table 1.8.1.1 and Listing 4.4). Cardiovascular medical history 
of interest at Screening will be summarized for the Safety Population and listed for all 
randomized subjects (Table 1.8.1.2 and Listing 4.5).
Screening Reproductive Status and Pregnancy Testing Results will be listed (Listing 4.6).


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018 
(Page 27 of 115) 
Prior, Concomitant, and Post-Treatment Medications/Treatments
6.3.4
All prescription and OTC medications, as well as any herbal or vitamin supplements, taken by 
the subject within 30 days of Visit 1 and all concomitant therapy taken by the subject while on 
study will be recorded on the Prior and Concomitant Medications case report form (CRF) page.
Coding: Verbatim medication/treatment terms will be coded by 
 and 
will be assigned a preferred term and an ATC (anatomic therapeutic class) term using the latest 
version of the World Health Organization Drug Dictionary (WHO-DD) available (version: 
3Q2016 or later). 
Multiple ATC assignments: If there are multiple ATC codes assigned to the same concomitant 
medication, the “primary” one based on a Pearl medical evaluation will be used.
Prior medication/treatment is any medication/treatment taken prior to study treatment, even if 
this medication continued to be taken on the day of the start of study treatment in the study or 
afterward (Appendix 1).
Concomitant medication/treatment is any medication/treatment reported as being taken after 
the start of the randomized study treatment in the study to the date prior to the last dose of study 
treatment for the subject. A medication with an onset date on or after the date of discontinuation 
from or completion of randomized study treatment for the subject will not be considered 
concomitant, but will be considered a Post-Treatment medication/treatment. 
Any medication/treatment which cannot be identified as Prior, Concomitant, or Post-Treatment 
will be considered as being in each of the categories that are possible from the available 
information. 
Concomitant/post-treatment COPD, COPD-Exacerbation, and Non-COPD related 
medications/treatments will be summarized by preferred term and actual treatment received for 
the Safety Population (Tables 1.11.1 to 1.11.7). COPD-related summaries will not include the 
COPD-exacerbation medications. Prior, concomitant/post-treatment COPD, COPD-
Exacerbation, and Non-COPD medications will be displayed in separate listings (Listings 4.7 to 
4.9, respectively). 
Reported prior medications for COPD, COPD-Exacerbation, and non-COPD-related medications 
will be tabulated for the Safety Population (Tables 1.10.1 to 1.10.4) and listed separately 
(Listings 4.7 to 4.9, respectively). 
Prior COPD medications will be tabulated (for the Safety population) for subjects having 
received any one, two, all three, or none of the following treatments (whether in fixed 
combination products or separately):  (1) a long-acting muscarinic antagonist (LAMA), (2) a 
long-DFWLQJȕDJRQLVWDQG an inhaled corticosteroid (Table 1.10.2). For this purpose, 
scheduled SAMA (Short-acting muscarinic antagonist) or SABA treatments are included. In 
addition, tabulations for long-acting muscarinic antagonists (LAMA) and long-DFWLQJȕDJRQLVWV
(LABA) will also be included. 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 28 of 115)
Post-treatment medications will be tabulated for subjects having received any one, two, all three, 
RUQRQHRIWKHIROORZLQJWUHDWPHQWVDPXVFDULQLFDQWDJRQLVWDȕDJRQLVWDQGDQ,&6
(Table 1.11.5).
Extent of Exposure to Study Medication and Compliance
6.3.5
Subject’s exposure to a study treatment will be determined by the duration of time (days) for 
which the doses were administered, defined as “([End date of treatment – Date of first dose of 
treatment] + 1)”. Percent compliance is defined as (total number of puffs of study treatment 
taken on a study day/total expected puffs taken on a study day) averaged across all days of a 
subject’s dosing between start of study treatment and last day on study treatment) x 100.
The expected number of puffs for a test day which is the last date of treatment will be 2, and the 
expected number of puffs for the last date of treatment which is not a test day will be 4 when a 
PM dose is taken but will be 2 otherwise; the expected number of puffs on dates prior to the last 
date of treatment will be 4.
The number of days of exposure to study treatment will be summarized for each treatment for the 
Safety Population. The total person-years of exposure for a treatment group, defined as the total 
exposure in the study across all subjects in the treatment, will also be provided by treatment 
(Table 1.12). In addition, treatment compliance will be provided in this summary. The treatment 
compliance will be categorized into 7 different groups depending on the degree of compliance: 0 
– – – – – !– DQG!
Also provided in this summary will be descriptive statistics (n, mean, standard deviation, 
median, minimum and maximum) for percent compliance by treatment. Treatment compliance 
will be reported in Listing 5.3. A listing of treatment dosing and dispensing information will be 
provided in Listing 5.1. Any comments related to study medication or any other additional study 
comments will be listed (Listing 9.6).
6.4
Efficacy Analyses
Estimands
6.4.1
Three estimands are defined for this study: the efficacy estimand, attributable estimand, and 
treatment policy estimand.
The primary estimand of interest is the efficacy estimand and is the effect of the randomized 
treatments in all subjects assuming continuation of randomized treatments for the duration of the 
study regardless of actual compliance. There are two additional estimands of interest. One is the 
attributable estimand, which is the effect of treatment in subjects attributable to the randomized 
treatment. For this estimand, discontinuation of randomized medication for reasons such as 
tolerability or lack of efficacy is considered a bad outcome. The second additional estimand of 
interest is the treatment policy estimand. This estimand is the effect of randomized treatment 
over the study period regardless of whether randomized treatment is continued. 
The primary analysis for the efficacy estimand will be conducted using the mITT Population 
where only data obtained prior to subjects discontinuing from randomized treatment will be 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 29 of 115)
utilized. This assumes that efficacy observed on treatment is reflective of what would have 
occurred after discontinuation of randomized treatment had they remained on treatment.
The second estimand of interest is the attributable estimand. Analyses of the attributable 
estimand will be conducted in the mITT Population. Data that are missing due to treatment 
discontinuation will be imputed based on the 5th or 95th percentile of the reference arm’s (FF 
MDI) distribution if the reason is reasonably attributable to tolerability or lack of efficacy. The 
5th percentile applies to an endpoint for which a higher value is a better outcome; however the 
95th percentile applies to an endpoint for which a higher value is a worse outcome. Other missing 
data are to be imputed using the observed data model, i.e. assumed to be missing at random 
(MAR). The number of imputations used for the derivation of the attributable estimand will be 
between 100 and 1000. More detail about the computation of the attributable estimand will be 
provided in subsequent sections (especially 6.4.4.1) and in the Details Appendix of this SAP.
Treatment discontinuations reasonably attributable to tolerability or lack of efficacy will be 
identified during the BDRM and documented in the BDRM minutes prior to unblinding. 
Discontinuations will be attributed to tolerability if the subject had an adverse event determined 
by the Investigator to be related to study drug, and for which study drug was permanently 
discontinued. Discontinuations will be attributed to lack of efficacy if ‘lack of efficacy’ is 
indicated to be the primary reason for discontinuation from study drug. For the remaining 
discontinuation categories, where specific reasons or criteria frequently need to be considered, 
decisions will be made and documented at the BDRM.
The third estimand of interest is the treatment policy estimand. Analyses of the treatment policy 
estimand will be conducted in the ITT Population, in which all observed data will be utilized 
regardless of whether subjects remain on randomized treatment.
There are two pairwise comparisons of interest, namely, BFF MDI (2 doses: 320/9.6 μg and 
160/9.6 μg) vs. FF MDI. Estimation results will be provided by randomized treatment and for 
each treatment difference for all comparisons, in each estimand. All comparisons will be 
performed for testing superiority.
Baselines and Baseline Covariates for Analysis
6.4.2
The mean of all evaluable 60- and 30-minute pre-dose spirometry assessments conducted at 
Day 1 (Visit 3) will be used to establish baseline for all FEV1, FVC, FEF25-75, and PEFR 
parameters.
For the diary symptom score parameters and rescue medication usage, baseline will be the 
average of the non-missing values from the diary data collected in the last seven days of the 
Screening Period.
For the SGRQ scores, baseline will be the value of the score calculated using the Day 1 
questionnaire data collected prior to the start of randomized study treatment.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 30 of 115)
%DVHOLQH&23'H[DFHUEDWLRQKLVWRU\IURPWKH9LVLW&5)SDJHLVVHWWRRUPRGHUDWH-or-
severe COPD exacerbations in the last 12 months.
ICS use at screening (Yes or No) is to be defined as follows - a subject will be considered to 
have had “ICS Use at Screening” if:
x
the subject was taking a medication that contained a glucocorticoid component (active 
ingredient) that is listed in the WHODRUG SDG (standardized drug grouping) of 
“CORTICOSTEROIDS”, and
x
the route of administration was “INHALED”, and
x
the medication was used at any time during the screening period (or in the 30 days prior to 
the screening period).
Baseline blood eosinophil count is the average of non-missing blood eosinophil count values 
prior to the first dose of study medication.
Baseline age is the age in years at the time of Informed Consent.
Baseline post-bronchodilator FEV1 is the highest available value of FEV1 obtained after dosing 
with Ventolin at Visit 2.
Baseline percent reversibility to Ventolin is 100 x (POST-PRE)/PRE, where PRE is the mean of 
the available 30 minute and 60 minute values of FEV1 prior to dosing with Ventolin at Visit 2, 
and POST is the post-bronchodilator FEV1 value defined above.
Visits and Time Windows for Visit-Based Efficacy Assessments:
Efficacy data obtained during unscheduled visits will not be used for any of the pre-defined 
efficacy analyses. Efficacy from scheduled and unscheduled visits will be listed.
Impact of Variable Length of the Study on the Analyses
6.4.3
The study will end when the last remaining randomized subject completes 12 weeks on 
randomized treatment. Given the variable length nature of the study, the distinction between 
“actual last visit” and “planned last visit” will be important for the analyses where the imputation 
of missing values is required.
Unlike a fixed duration study where each subject can reasonably be expected to stay in the study 
for the protocol-specified treatment period, subjects in a variable-length study will likely have 
different “planned last visits”, with those visits conditional on a protocol-specified event (in this 
case, the last subject being randomized). Section 8 of the protocol presents the rules for 
determining the “planned last visit” for subjects who are still in the study at the time of last 
subject randomized. For subjects who have withdrawn from the study before the last subject is 
randomized, their “planned last visit” will be determined based on the same rules, applied to the 
projected schedule of visits (Listing 1.3).


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 31 of 115)
When required for an analysis, imputation of missing data will only be performed up to and 
including the subject’s “planned last visit”. There will be no imputation of data beyond the 
subject’s “planned last visit” since those data were not expected to be collected per protocol. For 
analysis purposes, those data are not considered missing.
Primary Efficacy Analysis
6.4.4
The primary efficacy analysis of change from baseline in morning pre-dose trough FEV1 will be 
conducted for the efficacy estimand.
Change from Baseline in Morning Pre-Dose Trough FEV1
6.4.4.1
Change from baseline in morning pre-dose trough FEV1 is the primary endpoint in the US 
approach at Week 12 and the Ex-US approach over 24 weeks. It is also the ‘other’ endpoint over 
52 weeks and at each post-randomization in-clinic visit.
Change from baseline in morning pre-dose trough FEV1 at each visit is defined as the average of 
the 60 and 30 minute pre-dose values minus baseline. In subjects missing either of these pre-dose 
assessments, the value will be calculated from the single measurement. In subjects missing both 
pre-dose values, morning pre-dose trough FEV1 at that visit will not be calculated. Spirometry 
data from unscheduled visits will not be used for this analysis. Assessments obtained during 
early termination visits will be used if their timing is consistent with the next scheduled 
collection of spirometry data.
The change from baseline in morning pre-dose trough FEV1 will be analyzed using a repeated 
measures (RM) linear mixed model. The model will include treatment, visit, and treatment-by-
visit interaction, and ICS use at Screening as categorical covariates and baseline FEV1, baseline 
blood eosinophil count, and percent reversibility to Ventolin HFA as continuous covariates. An 
unstructured covariance (UN) matrix will be used to model correlation within a subject. If this 
model fails to converge, then a first-order autoregressive (AR(1)) structure will be used instead. 
In AR(1) model, subject will be included as a random effect.
Contrasts will be used to obtain estimates of the treatment differences at Week 12 and over 24 
and 52 weeks, and at each post-randomization visit. Two-sided p-values and point estimates with 
two-sided 95% CIs will be produced for each treatment difference. All comparisons will be for 
superiority.
The primary analysis will be conducted for the efficacy estimand. The analysis of the primary 
endpoint for the attributable estimand is considered secondary. Supportive analyses will be also
conducted for the treatment policy estimand (Tables and Figures 2.1.1 to 2.1.3 and Figures 
2.1.1.1 to 2.1.1.3 for the efficacy, attributable, and treatment policy estimands, respectively).
For the attributable estimand (for the analysis at Week 12 and the analysis over 24 weeks),
multiple imputation for missing values for morning pre-dose trough FEV1 will use mean changes 
from baseline based on the 5th percentile of the reference arm’s (FF MDI) distribution when 
missingness is reasonably attributable to tolerability or lack of efficacy (see Section 6.4.1). Other 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 32 of 115)
missing data are to be imputed using the observed data model. The variance used for the multiple 
imputation are described in the Details Appendix to this SAP. The number of imputations used 
for the derivation of the attributable estimand will be between 100 and 1000. Work by Seaman, 
White and Leacy (2014) and Cro (2017) show that Rubin’s rules can be validly used in 
conjunction with so called control-based multiple imputation methods, of which the attributable 
analysis is one type. Given these results we believe the attributable estimand analysis to be 
conservative from a Type I error control perspective. 
Exploration of the robustness of findings to missing data is discussed in Section 6.4.4.3.
Assumptions Checks and Removal of Outliers in Sensitivity Analyses
6.4.4.2
In general the distribution of spirometry measures is well-approximated by a normal distribution. 
Under some circumstances, atypical values can arise. Such values may disproportionately affect 
model-based estimates of the fixed effect and variance parameters. Prior to database lock and 
unblinding, the change from baseline values for efficacy endpoints will be examined as part of 
data quality management. This may include production of normal probability plots, kernel 
density estimates, and normal order outlier statistics. Based on this blinded evaluation, if atypical 
values are identified, nonparametric methods or data transformations (e.g. logarithmic or normal 
rank transformation) will be considered. If erroneous values are detected, every effort will be 
made to correct them prior to database lock. If these values cannot be corrected, they will be 
considered for removal from analysis. These analyses will be conducted if warranted to 
demonstrate the robustness of the primary and secondary results and reported in the Statistical 
Methods Appendix to the clinical study report (CSR).
The assumption of normality for the change from baseline in the morning trough FEV1 data will 
be checked by visually inspecting the distribution of the residuals. Also, model fit and the 
assumption of homogeneity of variance will be verified by inspection of scatter plots of predicted 
vs. residuals, residuals vs. treatment, residuals vs. ICS use (yes/no), and by box plots of residuals 
for model variables with a potential effect on variance (treatment, visit, and ICS use). Plots for 
scaled (marginal) residuals will be prepared (option=VCIRY on the model statement and ODS 
graphics option allows the production of plots using these residuals). As a sensitivity analysis, if 
appropriate, the linear RM model analysis will be conducted by allowing for heterogeneity of 
variance between treatments, visits (if unstructured covariance model fail to converge), and/or 
ICS use categories (yes/no). Note that the unstructured covariance structure allows for 
heterogeneity among the visits.
Some further assumptions checks are mentioned in the Details Appendix to this SAP.
Sensitivity Analyses for Missing Data
6.4.4.3
Sensitivity analyses will be conducted for the change from baseline in morning pre-dose trough 
FEV1 to evaluate the robustness of the primary analysis findings to missing data.
Robustness of results to missing data will be explored using tipping point analyses (Ratitch 
2013) for the efficacy, attributable and treatment policy estimands. The following table 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 33 of 115)
summarizes the multiple imputation-based sensitivity analyses under the PMM (pattern mixture 
model) framework that will be undertaken.
Table 4
Sensitivity Analyses for Morning Pre-Dose Trough FEV1
Efficacy Estimand
Attributable Estimand
Treatment Policy Estimand
mITT Population
mITT Population
ITT Population
Tipping point analysis 
#1:
All missing data are 
imputed using the 
observed data model 
except that for 
subjects in the 
treatment arm (not the 
comparator arm) 
values that are 
considered MNAR 
are imputed with the 
change from baseline 
in the treatment arm 
decremented by up to 
500 mL until the p-
YDOXH
Tipping point 
analysis #2:
All missing data are 
imputed using the 
observed data model 
except that for 
subjects in the 
treatment arm (not 
the comparator arm) 
values are imputed 
with the change from 
baseline in the 
treatment arm 
decremented by up 
to 500 mL until the 
p-YDOXH
Tipping point 
analysis:
MI based on the 5th
percentile of the reference 
arm’s distribution if 
treatment discontinuation 
is due to tolerability or 
lack of efficacy of study 
drug (as in the primary 
analysis of this estimand). 
Otherwise, all missing data 
are imputed using the 
observed data model 
except that for subjects in 
the treatment arm (not the 
comparator arm), values 
are imputed with the 
change from baseline in 
the treatment arm 
decremented by up to 500 
mL until the p-YDOXH
0.05.
Tipping point analysis:
All missing data are 
imputed using the observed 
data model except that for 
subjects in the treatment 
arm (not the comparator 
arm) values are imputed 
with the change from 
baseline in the treatment 
arm decremented by up to 
500 mL until the p-YDOXH
0.05.
MNAR = Missing not at random. MNAR will be defined and documented in the BDRM minutes prior to 
unblinding. The tipping point will be shown to at least a precision of 10 mL. Imputed values may not be impossible 
values – i.e. changes from baseline that would imply a negative FEV1 value. Thus the values will be imputed from a 
truncated distribution.
The primary analysis is for the efficacy estimand that includes data collected up until the time of 
discontinuation of treatment. The efficacy estimand quantifies the difference in outcomes for all 
patients as if they continued on their initially randomized treatment. The primary analysis uses a 
linear mixed model and assumes that all missing data are MAR or MCAR (missing completely at 
random).
Although the analysis for the attributable estimand starts with the same amount of missingness, 
less remains after imputation for missingness deemed attributable to the treatments is performed. 
These remaining missing data are imputed using the observed data model in the main analysis 
under the assumption of MAR. More detail about the computation of the attributable estimand is 
provided in subsequent sections and in the Details Appendix to this SAP.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 34 of 115)
Tipping-point analyses will be conducted to examine the impact of varying the treatment mean 
for missing data in subjects who discontinue BFF MDI. Multiple imputation (MI) techniques will 
be used to impute the missing data for these patients by varying the mean in the treatment arm. 
The change from baseline in the treatment arm will be decremented by up to 500 mL until the p-
YDOXHIRUWKHFRPSDULVRQRIWUHDWPHQWWRFRPSDUDWRUEHFRPHV A total of 10 imputations 
will be used for each set of tipping point analyses. This imputation technique will be applied in 
sensitivity analyses as described below.
Tipping Point Analyses of the Primary Estimand:
x
Tipping Point #1: this first set of analyses will impute diminished effects only for 
subjects on BFF MDI whose missing data are determined to be MNAR.
x
Tipping Point #2: this analysis will impute diminished effects for all missing data in the 
BFF MDI arm.
Note that for both tipping point analyses, all other missing data will be imputed using the 
observed data model.
Tipping Point Analysis of the Attributable Estimand:
For the attributable estimand, by definition, missing data in all arms due to tolerability and lack 
of efficacy are already imputed based on the 5th percentile of the reference arm’s distribution,
therefore the remaining missing data imputed using the observed data model in the main analysis 
are likely MAR or MCAR. Hence, there is no need to conduct a tipping analysis like #1 planned 
for the efficacy estimand. A tipping point analysis like #2 will be conducted where the non-
attributable missing data will be imputed using progressively diminished effects.
Tipping Point Analysis of the Treatment Policy Estimand:
For the treatment policy estimand, a tipping point analysis like #2 will be conducted where 
missing data in the treatment arm will be imputed using progressively diminished effects.
In all of these analyses, the imputed values that would have been seen are then combined with 
the observed values to provide a complete dataset. These data are then analyzed using the same 
linear mixed model used for the primary analysis. This analysis is repeated multiple times and 
the results are combined using Rubin’s formulae [Rubin, 1987].
For the tipping point analyses, tables giving results for each progressively diminished effect will 
be produced. Figures of delta (decrement in treatment effect) versus p-values will also be 
produced. Details of the sensitivity analyses are discussed in the Statistical Methods Appendix to 
the CSR.
Cumulative Responder Analysis
6.4.4.4
Additional sensitivity analyses will be implemented based on a cumulative responder approach 
(Farrar et al., 2006) for the change from baseline in morning pre-dose trough FEV1 at 12 Weeks 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 35 of 115)
and over 24 weeks (Tables 2.1.6.1 and 2.1.6.2 for the efficacy estimand, Tables 2.1.6.3 and 
2.1.6.4 for the treatment policy estimand). For the purpose of this analysis only, the change from 
baseline in morning pre-dose trough FEV1 over 24 weeks will be defined at the patient level as 
the simple average of all available values of the change up to Week 24.
A cumulative distribution plot by treatment arm will also be produced. The observed change 
from baseline in morning pre-dose trough FEV1 at Week 12 and over 24 weeks will be plotted on 
the x-axis, while the proportion of responders (subjects that equal or exceed that level of change) 
will be plotted on the y-axis (Figures 2.1.6.1 and 2.1.6.2 for the efficacy estimand, Figures 
2.1.6.3 and 2.1.6.4 for the treatment policy estimand). Subjects without post-baseline data will be 
considered non-responders in the analysis. For display purposes only, the range of the X axis will 
be from -1 to +1 liters [L] by increments of 0.01 liters in order to avoid the undue influence of 
outlying values. The cumulative responder curves for each treatment will then be compared 
pairwise using Kolmogorov-Smirnov tests. A cumulative responder analysis for the attributable 
estimand will not be performed as methodology to apply Rubin’s rules for combining multiply 
imputed data for such an analysis is not readily available.
Secondary Efficacy Analyses
6.4.5
Secondary efficacy analyses will be conducted for the efficacy, attributable, and treatment policy 
estimands. The efficacy estimand will be considered the primary. The analysis of the primary 
endpoint with the attributable estimand is considered a secondary efficacy analysis.  Otherwise, 
the attributable estimand will be supportive. The treatment policy estimand will be supportive.
Time to First Moderate or Severe COPD Exacerbation
6.4.5.1
Time to first moderate or severe COPD exacerbation is a secondary endpoint in the US and the 
Ex-US approaches.
Time to first moderate or severe COPD exacerbation is the time from first dose of study 
medication to the time of onset of the first moderate or severe COPD exacerbation. 
Only on-treatment exacerbations will be included for calculating the time to first moderate or 
severe COPD exacerbation for the efficacy estimand (see section 6.1).
Exacerbations occurring after the premature discontinuation of treatment will be considered for 
the treatment policy estimand. 
For the attributable estimand, missing data in all arms due to tolerability and lack of efficacy will 
be imputed using the 95th percentile of the reference arm’s (FF MDI) distribution. The imputed 
value will be drawn from a negative binomial distribution with mean exacerbation rate (and 
variance) based on the 95th percentile of the reference arm’s distribution. The remaining missing
data will be imputed using the observed data model, i.e. assumed to be missing at random 
(MAR) or missing completely at random (MCAR). Further information about the computation of 
the attributable estimand is described in the Details Appendix to this SAP (Appendix 6); 
however, the timing of imputed events is also needed. These will be obtained for each imputed 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 36 of 115)
event by randomly drawing a value from the uniform distribution over the interval that starts 
with time of treatment discontinuation (in study days) and ends at the end of study.
The time to first moderate or severe COPD exacerbation will be analyzed up through Week 52 
using a Cox regression model. Treatment comparisons will be performed using the model which 
includes treatment, baseline post-bronchodilator percent predicted FEV1, baseline blood 
HRVLQRSKLOFRXQWEDVHOLQH&23'H[DFHUEDWLRQKLVWRU\FRXQWU\DQG,&6XVHDW
Screening (Yes/No). SAS PROC PHREG will be used. Estimated adjusted hazard ratios relative 
to the comparator for each treatment comparison will be displayed along with the associated 
Wald two-sided 95% confidence intervals and p-values (Tables 2.8.1 to 2.8.3 for the efficacy, 
attributable, and treatment policy estimands, respectively). 
Time to first moderate or severe COPD exacerbation will be displayed graphically for each 
treatment using a Kaplan-Meier curve and analyzed using a log-rank test to compare the curves 
between the treatments (Figures 2.8.1 to 2.8.3 for the efficacy, attributable, and treatment policy 
estimands, respectively, and Listing 6.1.2.3). Subjects who complete the study on treatment and 
do not experience a COPD exacerbation over the treatment period will be censored at the date of 
study completion. For the efficacy estimand, subjects who discontinue study treatment early 
without experiencing a COPD exacerbation will be censored at the date of treatment 
discontinuation. For the treatment policy estimand, subjects who complete or withdraw from the 
study without experiencing a COPD exacerbation will be censored at the date of the last 
assessment or contact (including telephone contact).
Kaplan-Meier curves for time to moderate or severe COPD exacerbations will be constructed for 
completers vs. discontinuations (Figure 2.8.1.1), and, in separate plots, for MAR/MCAR vs. 
MNAR, and attributable vs. non-attributable discontinuation types (Figures 2.8.1.2 and 2.8.1.3).
Tipping Point Analyses for Time to First Moderate or Severe COPD Exacerbation
Robustness of results to missing data will be explored using tipping point analyses (Ratitch 
2013). A brief overview of the approach is summarized in the table below. 
Table 5
Sensitivity Analyses for Time to First Moderate or Severe COPD Exacerbations


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 37 of 115)
Efficacy Estimand
Attributable Estimand
Treatment Policy 
Estimand
mITT Population
mITT Population
ITT Population
Tipping point analysis 
#1:
All missing data are 
imputed using the 
observed data model 
except that for subjects 
in the treatment arm 
(not the comparator 
arm) values that are 
considered MNAR are 
imputed with the rate in 
the treatment arm 
increased by up to 1.5 
exacerbations/year until
the p-YDOXH.
Tipping point analysis 
#2:
All missing data are 
imputed using the 
observed data model 
except that for subjects 
in the treatment arm 
(not the comparator 
arm) values are 
imputed with the rate 
in the treatment arm 
increased by up to 1.5
exacerbations/year 
until the p-YDOXH
0.05.
Tipping point 
analysis:
MI using the 95th
percentile of the 
reference arms’ 
distribution (for the 
rate of moderate or 
severe COPD 
exacerbation) if 
treatment 
discontinuation is due 
to tolerability or lack 
of efficacy of study 
drug (as in the primary 
analysis of this 
estimand). Otherwise 
all missing data are 
imputed using the 
observed data model 
except that for subjects 
in the treatment arm 
(not the comparator 
arm) values are 
imputed with the rate 
in the treatment arm 
increased by up to 1.5 
exacerbations/year 
until the p-YDOXH
0.05.
Tipping point analysis:
All missing data are 
imputed using the 
observed data model 
except that for subjects 
in the treatment arm (not 
the comparator arm) 
values are imputed with 
the rate in the treatment 
arm increased by up to 
1.5 exacerbations/year 
until the p-YDOXH 0.05.
MNAR = Missing not at random. 
The multiple imputation will be applied to the moderate or severe COPD exacerbation events 
within the negative-binomial analysis framework for the rate of moderate or severe COPD 
H[DFHUEDWLRQVXVLQJYDOXHVRIįWKDt increase the rate in the treatment arm by up to 1.5 
exacerbations/year. For this method, an underlying negative binomial stochastic process for the 
rate of exacerbations is assumed and post-treatment-discontinuation counts will be imputed 
conditional upon the reason for treatment discontinuation (see Appendix 6 for details). 
A dataset with event counts through end of study will be created; however, the timing of the first 
imputed event is also needed. These times will be obtained for each imputed event by randomly 
drawing a value from the uniform distribution over the interval that starts with time of treatment 
discontinuation (in study days) and ends at the end of study. Missing values will first be imputed 
for the missing COPD exacerbation events prior to the computation of the time to the first 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 38 of 115)
moderate or severe COPD exacerbation (for the sensitivity analysis). After imputation, the 
analysis will proceed to use Cox regression (as described above) and subsequently the multiple-
imputation results will be combined using Rubin’s formulae [Rubin, 1987].
Time to First Clinically Important Deterioration
6.4.5.2
&OLQLFDOO\LPSRUWDQWGHWHULRUDWLRQ&,'LVGHILQHGDVP/decrease from baseline in trough 
FEV1RUSRLQWVLQFUHDVHIURPEDVHOLQHLQ6*54WRWDOVFRUH, or a TDI focal score of -1 point 
or less, or treatment-emergent moderate-or-severe COPD exacerbation occurring up to Week 52. 
Time to CID is a secondary endpoint in the Ex-US approach.
Time to first CID analysis will be performed using a Cox regression model. The model will 
include treatment, baseline post-bronchodilator percent predicted FEV1, baseline blood 
HRVLQRSKLOFRXQWEDVHOLQH&23'H[DFHUEDWLRQKLVWRU\FRXQWU\DQG,&6XVHDW
Screening (yes/no). Time to a CID event will be based on the component event which occurs 
first. Subjects who do not experience a CID event will be censored at the earliest day among the 
component censoring times. COPD exacerbations happening after Week 52 will not be counted 
as CID events. Estimated adjusted hazard ratios will be displayed along with associated 95% CI 
and p-values (Tables 2.11.1 to 2.11.3 for the efficacy, attributable, and treatment policy 
estimands, respectively). Time to first CID will be displayed graphically for each treatment 
group using a Kaplan-Meier curve and analyzed using a log-rank test to compare the curves 
between the treatments (Figures 2.11.1 and 2.11.3 for the efficacy and treatment policy 
estimands, respectively).
For the analysis of the attributable estimand, missing data that have been reasonably attributed to 
tolerability or lack of efficacy will be imputed based on either the 5th or the 95th percentile of the 
reference arm’s (FF MDI) distribution. The attributable estimand for time to CID will be 
computed by applying the percentile penalty to each of the four component variables 
simultaneously; it uses multiple by-visit imputation of pre-dose trough FEV1 (at visits for which 
they are missing) (as described in Sections 6.4.4.3), of the SGRQ total score (as described in 
Section 6.4.5.4), of the TDI focal score in a manner similar to that for SGRQ, and MI of time to 
first moderate-or-severe COPD exacerbation (Section 6.4.5.1). A complete dataset for the COPD
exacerbation count will be created analogously to that described in the Details Appendix to this 
SAP; however, the timing of imputed events is also needed. These will be obtained for each 
imputed event by randomly drawing a value from the uniform distribution over the interval that 
starts with time of treatment discontinuation (in study days) and ends at the end of study. 
Transition Dyspnea Index
6.4.5.3
TDI focal score over 24 weeks is a secondary efficacy endpoint in the Ex-US approach, and an 
‘other endpoint’ over 12 weeks, over 52 weeks, and at each post-randomization visit. Individual 
components of the TDI (functional impairment, magnitude of task, and magnitude of effort) are 
also ‘other endpoints’ over 12, 24 and 52 weeks, and at each post-randomization visit.
Assessments of dyspnea will be obtained using the BDI/TDI (where BDI is the Baseline Dyspnea 
Index). The BDI/TDI questionnaire can be found in Protocol Appendix 6.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 39 of 115)
At Randomization (Visit 3), the severity of dyspnea at baseline will be assessed using the BDI. 
BDI components are functional impairment, magnitude of task, and magnitude of effort (Listing 
6.1.6). The possible range of values for each BDI component score is 0 (very severe impairment) 
to 4 (no impairment). The BDI component scores are summed to determine the BDI focal score 
(0 to 12) (i.e., the lower the score, the worse the severity of dyspnea).
At subsequent visits (as per Schedule of Events: see of the Schedule of Events in the protocol),
change from baseline will be assessed using the TDI. TDI components include: Change in 
Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort 
(Listing 6.1.6). The TDI component score ranges from -3 (major deterioration) to +3 (major 
improvement). The sum of all component scores yields the TDI focal score (-9 to +9) (i.e., the 
lower the score, the more deterioration from baseline). 
The difference between treatment groups in TDI focal score over 12, 24, and 52 weeks and at 
each post-randomization visit will be analyzed using a similar RM approach as for the primary 
endpoint, but using BDI instead of baseline FEV1 in the model, and adding baseline post-
bronchodilator percent predicted FEV1 as a continuous covariate. Thus the model will include 
treatment, visit, treatment by visit interaction, and ICS use at Screening as categorical covariates 
and BDI, baseline blood eosinophil count, percent reversibility to Ventolin HFA and baseline 
post-bronchodilator percent predicted FEV1 as continuous covariates. Scoring and handling 
of missing items will be conducted in accordance with the user’s guide for the TDI score. Two-
sided p-values and point estimates with 2-sided 95% CIs will be produced for each treatment 
difference (Table and Figure 2.2.1 for the efficacy estimand). Supportive analyses for the 
attributable estimand and treatment policy estimand will be conducted (Tables and Figures 2.2.2 
to 2.2.3, respectively).
The attributable estimand will be computed in a similar manner as the attributable estimand is 
computed for change from baseline in morning pre-dose trough FEV1 at Week 12 as described in 
Section 6.4.4.1.
In addition, the difference between treatments for the individual components of the TDI: 
functional impairment, magnitude of task, and magnitude of effort will each be analyzed over 12, 
24, and 52 weeks, and at each post-baseline visit for the efficacy estimand using the same 
modeling approach as for the TDI focal score (Table 2.2.4 and Figures 2.2.4.1-2.2.4.3 for the 
functional impairment, the magnitude of task and the magnitude of effort for the efficacy 
estimand).
Furthermore, responder analyses will be performed for the TDI focal score where responders are 
defined as subjects with a response of 1.0 points or more (corresponding to at least a minor 
improvement) on average over 12, 24, and 52 weeks. Logistic regression will be used to compare 
the treatment groups with BDI, baseline blood eosinophil count, and percent reversibility to 
Ventolin HFA as continuous covariates and treatment, and ICS use at Screening as categorical 
covariates. P-values and odds ratios with 95% CIs will be produced for each treatment 
comparison (Table 2.2.5 for the efficacy estimand).


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 40 of 115)
For the TDI, at each visit, if a response to any of the three questions is missing, then the focal 
score will also be considered missing. For the TDI responder analyses, subjects without post-
baseline data will be considered to be non-responders in the analysis.
TDI and BDI data will be listed in Listing 6.1.6.
St. George’s Respiratory Questionnaire
6.4.5.4
3HUFHQWDJHRIVXEMHFWVDFKLHYLQJDQ0&,'RILQ6*54WRWDOVFRUHLVDVHFRQdary endpoint in 
the US approach at Week 12 and in the Ex-US approach over 24 Weeks. It is also an ‘other 
point’ over 52 weeks and at each post-randomization in-clinic visit. The change from baseline in 
SGRQ total score and in individual domains of the SGRQ (Symptoms, Activity, and Impacts) 
over 12, 24 and 52 weeks, and at each post-randomization in-clinic visit, are ‘other endpoints’.
The SGRQ will be used to provide the health status/health-related QoL measurements in this 
study (see Protocol Appendix 7). The SGRQ contains 50 rated items divided into three domains: 
"Symptoms" concerned with respiratory symptoms, their frequency, and severity; "Activity" 
concerned with activities that cause or are limited by breathlessness; and "Impacts" which covers 
a range of aspects concerned with social functioning and psychological disturbances resulting 
from airway disease. Individual items of SGRQ data will be listed (Listings 6.1.7 for All Subjects 
Randomized).
A score will be calculated for each component and a "Total" score will also be calculated 
(Listings 6.1.9 for All Subjects Randomized). In each case, the lowest possible value is zero and 
the highest is 100. Higher values correspond to greater impairment of QoL.
Scoring and handling of missing items will be conducted in accordance with the user’s guide for 
the SGRQ. Each response is to be given a unique empirically derived weight between 0 and 100; 
the weights of all responses are then summed up and divided by the maximum possible score and 
expressed as a percentage.
Responder analyses of SGRQ as a secondary efficacy endpoint will be performed, where 
UHVSRQGHUVDUHGHILQHGDVVXEMHFWVZLWKDQLPSURYHPHQWRI points at week 12, on average 
over 24 weeks, over 52 weeks, and at each post-randomization in-clinic visit. For the SGRQ 
responder analyses, subjects without post-baseline data or who discontinue treatment for any 
reason will be considered to be non-responders for the analysis. Logistic regression will be used 
to compare the treatment groups with baseline SGRQ score, baseline blood eosinophil count, 
baseline post-bronchodilator percent predicted FEV1, and percent reversibility to Ventolin HFA 
as continuous covariates, and treatment and ICS use at Screening as categorical covariates. 
P-values and odds ratios with 95% CIs will be produced for each treatment comparison 
(Tables 2.3.3 to 2.3.5 for the efficacy, attributable, and treatment policy estimands, respectively).
The attributable estimand for responder analysis of SGRQ will be computed as follows. First, 
multiple imputations will be performed on the continuous total SGRQ scores in a similar manner 
as for the attributable estimand that is computed for change from baseline in morning pre-dose 
trough FEV1 at Week 12 as described in Section 6.4.4.1 except that the 95th percentile will be 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 41 of 115)
used instead of the 5th percentile. After that, it will be determined whether the subject has 
attained the MCID. The analysis will proceed using logistic regression as described above, 
followed by combining of results across the multiple imputations using the formulae of Rubin 
[Rubin, 1987].
The difference between treatment groups in the change from baseline in SGRQ over 12 weeks, 
24 weeks, over 52 weeks, and each post-baseline visit will be evaluated using a similar RM 
approach as for TDI focal score. The model will include treatment, visit, and treatment by visit 
interaction, ICS use at Screening as categorical covariates and baseline SGRQ score, baseline 
blood eosinophil count, percent reversibility to Ventolin HFA, and baseline post-bronchodilator 
percent predicted FEV1 as continuous covariates. Missing SGRQ total scores will not be 
imputed. Two-sided p-values and point estimates with 2-sided 95% CIs will be produced for 
each treatment difference (Table and Figure 2.3.1 for the efficacy estimand). 
Individual domains of the SGRQ will also be analyzed in a similar fashion as the total score 
(Table 2.3.2 for the efficacy estimand).
Tipping Point Analyses for Percentage of Subjects achieving an MCID of 4 Units or More in 
SGRQ Total Score at Week 12
Robustness of results to missing data will be explored using tipping point analyses (Ratitch 
2013). Details of the methods are similar to sensitivity analyses of FEV1 (found in Section 
6.4.4.3 and in the Statistical Methods Appendix to this SAP), but with the model for SGRQ total 
score described above and with the maximum increase 16 units for change from baseline in 
SGRQ total score for the tipping point analyses. 
Rescue Ventolin HFA Use
6.4.5.5
Change from baseline in average daily rescue Ventolin HFA use is a secondary endpoint in the US 
approach over 12 Weeks and in the Ex-US approach over 24 Weeks. It is also an ‘other point’ for 
over 52 weeks and over each 4-week interval of the 52-week treatment period. Percentage of 
days with ‘no rescue Ventolin HFA use’ is an ‘other endpoint’.
The number of puffs of rescue Ventolin HFA taken in the previous 12 hours since the previous 
(AM or PM) dose will be recorded in the subject diary in the morning and evening. The mean 
daily number of puffs of rescue Ventolin HFA used by subjects during the study will be 
calculated overall and for each of the 4-week intervals of the 52-week treatment period and 
provided in a diary data listing (Listing 6.1.3 for All Subjects Randomized). Diary data recorded 
during the last 7 days of the Screening Period will be used to calculate the baseline. 
For every interval of time over which the mean number of puffs of rescue will be calculated, 
records with missing values will be ignored in both the numerator and denominator. As such, the 
denominator will be adjusted based on the number of days (including half days) with 
non-missing values. That is, the mean daily number of puffs of daytime rescue use (M_DT) will 
be set to the total number of daytime puffs divided by the number of half-days when daytime 
rescue use was recorded. The mean daily number of puffs of nighttime rescue use (M_DN) will 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 42 of 115)
be set to the total number of nighttime puffs divided by the number of half-days when the 
nighttime rescue use was recorded. The mean daily rescue use (puffs) is then two multiplied by 
the mean of M_DT and M_DN.
The difference between treatment groups in the change from baseline in rescue Ventolin HFA 
usage over 12, 24 and 52 weeks will be evaluated using a linear RM analysis of covariance 
(ANCOVA) model which will include treatment, 4-week time interval (1 to 13), treatment by 4-
week interval interaction, and ICS use at Screening as categorical covariates, and baseline rescue 
Ventolin HFA use, baseline blood eosinophil count, baseline FEV1, and percent reversibility to 
Ventolin HFA as continuous covariates. A UN matrix will be used to model additional 
autocorrelation within subject. If this model fails to converge, then an AR(1) structure will be 
used instead. In the AR(1) model, subject will be included as a random effect.
Contrasts will be used to obtain estimates of the treatment differences over the treatment period. 
Two-sided p-values and point estimates with two-sided 95% CIs will be produced for each 
treatment difference. The main analysis will be conducted using the efficacy estimand (Table and
Figure 2.4.1). Supportive analyses for the attributable estimand, treatment policy estimand, and 
RVU population will be performed (Tables and Figures 2.4.2, 2.4.3 and 2.4.6).
The attributable estimand (for the analysis of average daily rescue Ventolin HFA use) will be 
computed in a similar manner as the attributable estimand is computed for change from baseline 
in morning pre-dose trough FEV1 at Week 12 as described in Section 6.4.4.1 except that the 95th
percentile will be used instead of the 5th percentile.
As supportive analyses, the treatment difference for each 4-week interval will be evaluated and 
summarized. Additionally, as supportive analyses, daytime rescue Ventolin HFA use and night-
time rescue Ventolin HFA use will be evaluated and summarized in a similar fashion. Two-sided 
p-values and point estimates with 2-sided 95% CIs will be produced for each treatment 
difference (Tables and Figures 2.4.4 and 2.4.7 for the daytime rescue Ventolin use, and 2.4.5
and 2.4.8 for the nighttime rescue Ventolin use, for the efficacy estimand and RVU population).
Tipping Point Analyses for Rescue Ventolin HFA Use Over 12 Weeks
Robustness of results to missing data will be explored using tipping point analyses (Ratitch 
2013). Details of the methods are similar to sensitivity analyses of FEV1 (found in Sections 
6.4.4.3 DQGLQWKH'HWDLOV$SSHQGL[WRWKLV6$3DQGXVLQJWKHPD[LPXPYDOXHRIį SXIIV
but with the model for rescue Ventolin HFA use described above. Multiple-imputation results 
will be combined using Rubin’s formulae [Rubin, 1987].
Additional sensitivity analyses will be implemented based on a cumulative responder approach 
as described in Farrar 2006 for the change from baseline in average daily rescue medication over 
12 weeks (Tables 2.4.10.1 and 2.4.10.2 for the efficacy and treatment policy estimands, 
respectively). A cumulative distribution plot by treatment arm (Farrar et al., 2006) will also be 
produced. The observed change from baseline in average daily rescue medication over 24 weeks 
will be plotted on the X axis, while the proportion of responders (subjects that equal or exceed 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 43 of 115)
that level of change) will be plotted on the Y axis (Figure 2.4.10.1 and 2.4.10.2 for the efficacy 
and treatment policy estimands, respectively). Subjects without post-baseline data or who 
discontinue treatment for any reason will be considered non responders for all values. For 
display purposes only, the range of the x-axis will be from the 1st percentile to the 99th percentile 
irrespective of treatment in order to avoid the undue influence of outlying values. The 
cumulative responder curves for each treatment will then be compared pairwise using 
Kolmogorov-Smirnov tests. Cumulative responder analysis for the attributable estimand will not 
be performed as methodology to apply Rubin’s rules for combining multiply imputed data for 
such an analysis is not readily available.
The percentage of days with ‘no rescue Ventolin HFA use’ over 12, 24, and 52 weeks, and for 
each 4-week interval of the Treatment Period will be evaluated with an ANOVA model. A ‘day 
with no rescue use’ is defined as any day where the subject reported zero puffs of rescue 
Ventolin HFA. The rescue Ventolin HFA usage diary data from days where rescue Ventolin 
HFA usage data is non-missing will be used to ascertain the days with “no rescue Ventolin HFA 
use”. The percentage of days with no rescue use will be calculated as 100 x (number of days no 
rescue Ventolin use over the entire treatment period / number of days with non-missing rescue 
Ventolin use over the entire treatment period). For the efficacy estimand, days after 
discontinuation of study medication will not be used. The ANCOVA model will evaluate 
treatment differences and include baseline rescue Ventolin HFA use and percent reversibility to 
Ventolin HFA as continuous covariates and region, smoking status at baseline, and ICS use at 
Screening as categorical covariates. Two-sided p-values and point estimates with 2-sided 95% 
CIs will be produced for each treatment difference (Tables 2.5.1 to 2.5.2 for the efficacy 
estimand and RVU population, respectively).
EXACT Total Score
6.4.5.6
Change from baseline in EXACT total score over 24 weeks is a secondary efficacy endpoint in 
the Ex-US approach. The 11-item RS-Total Score, as well as the 3 symptom domain scores for 
breathlessness, cough and sputum, and chest symptoms over 24 weeks and 52 weeks, and over 
each 4-week interval of the 52-week treatment period are ‘other endpoints’.
The EXACT is a 14-item patient reported outcome (PRO) from the daily diary which will be 
used to measure the effect of treatment on exacerbations, and on the severity of respiratory 
symptoms. Mean change from baseline in the daily EXACT Total Score, the 11-item E-RS Total 
Score, as well as 3 subscale scores, RS-Breathlessness, RS-Cough and Sputum, and RS-Chest 
Symptoms, will be calculated over each post-randomization 4-week interval of the treatment 
period. The last 7 days of the Screening Period will be used to calculate the baseline. 
The mean change from baseline in the EXACT Total Score (Tables and Figures 2.6.1 to 2.6.3 for 
the efficacy, attributable, and treatment policy estimands, respectively), E-RS Total Score (Table 
and Figure 2.6.4 for the efficacy estimand), RS-Breathlessness, RS-Cough and Sputum, and RS-
Chest Symptoms (Table and Figure 2.6.5 for the efficacy estimand) over each 4-week interval 
will be analyzed using a similar RM model as for TDI to estimate treatment effects over 24 and 
52 weeks, but using the corresponding baseline mean score instead of the BDI as a covariate. 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 44 of 115)
Instead of visit, the number of the relevant respective 4-week interval (Interval 1 to Interval 13) 
will be used as a categorical covariate in the model. Thus the model will include treatment, time 
interval, and treatment by time-interval interaction, and ICS use at Screening as categorical 
covariates and baseline score, baseline blood eosinophil count, percent reversibility to Ventolin 
HFA, and baseline post-bronchodilator percent predicted FEV1 as continuous covariates. A UN 
correlation matrix will be used to model additional autocorrelation within subject. If this model 
fails to converge, then an AR(1) structure will be used instead. In the AR(1) model, subject will 
be included as a random effect. 
Two-sided p-values and point estimates with 2-sided 95% CIs will be produced for each 
treatment difference. EXACT data will be listed in Listing 6.1.5.
The attributable estimand (for the analysis of EXACT total score) will be computed in a similar 
manner as the attributable estimand is computed for change from baseline in morning pre-dose 
trough FEV1 over 24 weeks as described in Section 6.4.4.1 except that the 95th percentile will be 
used instead of the 5th percentile.
Other Efficacy Analyses
6.4.6
Other Spirometry Endpoints
6.4.6.1
The analysis for between-treatment comparisons of changes from baseline in morning pre-dose 
trough FEV1 over 12, 24, and 52 weeks, and at each post-randomization in-clinic visit has 
already been described in Section 6.4.4.1 (Tables and Figures 2.1.1 to 2.1.3).
Similar analyses will be conducted for forced vital capacity (FVC), peak expiratory flow rate 
(PEFR), and forced expiratory flow between 25% and 75% of FVC (FEF25-75) over 12, 24 and 52 
weeks, and at each post randomization in-clinic visit for the efficacy estimand. The baseline 
covariate for each model will be endpoint-specific (Tables and Figures 2.7.1 to 2.7.3 for change 
from baseline in morning pre-dose trough FVC, PEFR, and FEF25-75).
Rate of COPD Exacerbations
6.4.6.2
COPD Exacerbations
A COPD exacerbation is defined as a change in the subject’s usual COPD symptoms that lasts 
two or more days, is beyond normal day-to-day variation, is acute in onset, and may warrant a 
change in regular medication. The change in symptoms must include at least one major COPD 
symptom and at least one other major (dyspnea, sputum volume, and sputum color) or minor 
symptom (cough, wheeze, sore throat, cold symptoms such as rhinorrhea or nasal congestion, 
and fever without other cause).
Exacerbations will be considered moderate if they result in:
x
Use of systemic corticosteroids and/or antibiotics for at least three days; a single depot 
injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic 
corticosteroids.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 45 of 115)
Exacerbations will be considered severe if they result in:
x
An inpatient COPD-related hospitalization (documentation stating that the subject was 
hospitalized for the COPD H[DFHUEDWLRQRUDUHFRUGRIWKHVXEMHFWEHLQJDGPLWWHGIRU
hours to an observation area, the emergency department, or other equivalent healthcare 
facility depending on the country and healthcare system).
x
COPD-related death.
Moderate and severe COPD exacerbations will be entered in the eCRF. 
Additionally, the Investigator may identify certain events (recorded on the same CRF page) 
which don’t entirely meet the criteria above as exacerbations; the justifications supporting the 
Investigator’s judgment will be recorded on a separate page on the eCRF.
COPD exacerbations not meeting the criteria for moderate or severe COPD exacerbations will be 
considered to be mild COPD exacerbations. For more detail about moderate-or-severe, severe, 
and any-severity COPD exacerbation events (and their start and end dates) and how they are 
operationally defined, see the subsections titled “Duration of COPD Exacerbation,” “Moderate-
or-Severe Exacerbation and Severe Exacerbation: Operational Definitions”, and “Exacerbation 
of any Severity: Operational Definition”.
The rate of COPD exacerbations of any severity, moderate or severe COPD exacerbations, 
severe COPD exacerbations, COPD exacerbations treated with systemic steroids, and COPD 
exacerbations treated with antibiotics will be analyzed using negative binomial regression as 
implemented in SAS PROC GENMOD. Treatments will be compared adjusting for baseline 
post-bronchodilator percent predicted FEV1 and baseline blood eosinophil count as continuous 
FRYDULDWHVDQGEDVHOLQH&23'H[DFHUEDWLRQKLVWRU\DQG,&6XVHDW6FUHHQLQJ\HVQRDV
categorical covariates. COPD exacerbations will be considered separate events provided that 
there are more than 7 days between the recorded stop date of the earlier event and the start date 
of the later event. Time at risk of experiencing an exacerbation will be used as an offset variable 
in the model.
For the efficacy estimand, the time at risk is defined as time of exposure to randomized treatment 
– not during or within 7 days after an exacerbation of equal or greater severity – until the last 
dosing date – not during or within 7 days after an exacerbation of equal or greater severity – up
to the last recorded date of any assessment or contact for the subject (including telephone 
contact).
For moderate-or-severe COPD exacerbations that were identified apart from an eDiary alert, the 
symptom information is listed in Listing 6.1.2.2.
The number of exacerbations, the percentage of subjects who experience exacerbations, 
exacerbation rates, and rate ratios comparing treatments will be summarized for the efficacy 
estimand for moderate-or-severe exacerbations (Table 2.8.9), for any severity of exacerbations 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 46 of 115)
(Table 2.8.10), for severe COPD exacerbations (Table 2.8.11), for COPD exacerbations treated 
with systemic steroids (Table 2.8.12), and for COPD exacerbations treated with antibiotics 
(Table 2.8.13).
Follow-up time at risk will be summarized and displayed graphically for moderate or severe 
COPD exacerbations for the efficacy estimand (Table and Figure 2.8.9a), for any severity of 
exacerbations (Table and Figure 2.8.10a), for severe COPD exacerbations (Table 2.8.11a), for 
COPD exacerbations treated with systemic steroids (Table 2.8.12a), and for COPD exacerbations 
treated with antibiotics (Table 2.8.13a).
Duration of COPD Exacerbation 
For moderate or severe exacerbations, the duration is defined by the length of prescribed 
treatment (using the eCRF COPD exacerbation page), whereas for mild exacerbations, the 
duration is defined by the length of symptoms. 
For moderate or severe COPD exacerbations, the start date will be defined as the start date of 
prescribed treatment with a systemic corticosteroid or systemic antibiotic and the stop date will 
be defined as the latter of the last day of prescribed treatment with a systemic corticosteroid or 
systemic antibiotic (if applicable). If the subject dies before being treated or hospitalized, then 
the start and stop date will be the date of death. In order to ensure that the same event is not 
counted twice, consecutive or concurrent moderate or severe COPD exacerbations with equal to 
or fewer than 7 days between the recorded stop date of the earlier event and start date of the later 
event will be considered the same event and assigned the maximum severity between the two.
For mild COPD exacerbations, start date will be defined as the onset of worsened symptoms as 
recorded by the subject in the eDiary, and the stop date will be defined as the last day of 
worsened symptoms. In order to ensure that the same event is not counted twice, consecutive or 
concurrent mild COPD exacerbations with equal to or fewer than 7 days between the recorded 
stop date of the earlier event and start date of the later event will be considered the same event. 
In addition, in order to not double-count exacerbations that are moderate or severe, eDiary data 
from dates within 7 days prior to or after a moderate or severe exacerbation will not be counted 
as additional mild COPD exacerbations. This implies that continuing worsened symptoms that 
meet the definition of a mild exacerbation would need to be present at least 2 days prior to the 7-
day period immediately preceding the start date of a moderate or severe COPD exacerbation in 
order to be considered a separate event. Similarly, worsened symptoms would need to be present 
for at least 2 days after the 7-day period immediately following a moderate or severe COPD 
exacerbation to be considered a separate event.
Analyses of each severity of exacerbation will account for the time that subjects are at risk of 
having an exacerbation of that severity or greater. Time during or immediately following – i.e. 
within 7 days of – an exacerbation will not be considered as part of the time that the subject was 
at risk. However, time during or immediately following an exacerbation of lower severity will be 
included since, for example, a subject experiencing a mild exacerbation is still at risk of the event 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 47 of 115)
increasing in severity and becoming a moderate exacerbation. Thus, for example, in the analysis 
of severe COPD exacerbations, subjects will still be considered to be at risk of an exacerbation 
even during or within 7 days after a mild or moderate exacerbation. Likewise, in the analysis of 
moderate-or-severe COPD exacerbations, subjects will still be considered to be at risk of an 
exacerbation even during or within 7 days after a mild exacerbation.
Moderate-or-Severe Exacerbation and Severe Exacerbation: Operational Definitions
Moderate exacerbations and severe exacerbations will be defined based on information from the 
COPD Exacerbation eCRF page. A time interval from a single COPD exacerbation eCRF page 
will be designated as being during an event of a moderate-or-severe COPD exacerbation if either 
antibiotics or oral corticosteroids were administered for the exacerbation.
Call this time interval a “P-Interval”. The start date of the P-Interval is the earliest start date of 
the above, and the stop date will be defined as the last stop day of the above. If the subject was 
hospitalized due to the exacerbation or if the exacerbation led to a COPD-related death, then the 
severity of “severe” will be assigned to this P-interval; otherwise the severity of “moderate” will 
be assigned. The later among the stop date of the treatment with a systemic corticosteroid and the 
stop date of the treatment with an antibiotic will be the end date of the COPD exacerbation (i.e. 
the end of the P-Interval). 
An overarching interval of (any number of) such P-Intervals – including any P-Intervals with an 
end date not more than 7 days prior to the start date of some other P-Interval or with a start date 
not more than 7 days after the end date of some other P-Interval – and including the days in any 
gaps between them – will be called an “QMS-Interval”. This QMS-interval will represent the 
consolidated duration of several exacerbations recorded on different CRF pages. This QMS-
Interval will be considered to be a single event of a moderate-or-severe COPD exacerbation. See 
Figure 2.
A P-interval of severe COPD exacerbation is called a “severe” P-Interval. Any QMS interval that 
contains at least one “severe” P-Interval will also be called a “QS-Interval”. This QS-Interval 
will be considered to be a single event of a severe COPD exacerbation. See Figure 2.
Figure 2
Overarching Intervals of Moderate-or-Severe (QMS) and Severe (QS) COPD 
Exacerbations
P
(Severe)
Å3 daysÆ
P
(Severe)
Å 8  days  Æ
P
Å5 daysÆ
P
(Severe)
QMS
QMS
QS
QS
A P-interval is a moderate-or-severe COPD exacerbation instance from a single CRF page.
In a “Severe” P-Interval, the maximum severity of the COPD exacerbation is “severe”.
A QMS interval is an overarching moderate-or-severe COPD exacerbation event encompassing multiple 
CRF pages.
A QS interval is an overarching severe COPD exacerbation event encompassing multiple CRF pages.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
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Exacerbation of any Severity: Operational Definition
Using eDiary data, a day will be designated as being during an event of a COPD exacerbation of 
some severity if (1) there was at least one major symptom and there was at least one other major 
or minor symptom and if (2) on an adjacent day there was at least one major symptom and there 
was at least one other major or minor symptom. Denote such a day as a “Category-D” day. 
An interval of (any number of) such Category-D days – including any Category-D days not more 
than 7 days apart from some other Category-D day – and including the days in any gaps between 
them – will be called an “I-Interval”. See Figure 3.
An overarching interval coalescing (any number of) P-Intervals and I-Intervals – including any 
such P-or-I-intervals with an end date not more than 7 days prior to the start date of some other 
P-or-I-Interval or with a start date not more than 7 days after the end date of some other P-or-I-
interval – and including the days in any gaps between them – will be called a “QQ-Interval”. 
This QQ-interval will represent the consolidated duration of several exacerbations recorded on 
different CRF pages or identified from subject diary data. This QQ-Interval will be considered to 
be a single event of an any-severity COPD exacerbation. See Figure 4.
Figure 3
Overarching Intervals (I) of Mild-Moderate-or-Severe COPD Exacerbation Events 
Based on e-Diary Symptom Data
D D D D D D D D Å 5 days Æ D D D D D D Å 9 days  Æ D D D Å
10 days    Æ D D
I
I
I
A Category-D day is a day with mild-moderate-or-severe COPD exacerbation based on e-diary symptom 
data.
An I-Interval is an overarching mild-moderate-or-severe COPD exacerbation event encompassing 
multiple clusters of e-diary symptom days.
Figure 4
Overarching Intervals (QQ) of Mild-Moderate-or-Severe COPD Exacerbation 
Events Incorporating Both CRF Data and e-Diary Symptom Data 
P
Å2 daysÆ
I
Å3 daysÆ
I
Å 10 days Æ
P
QQ
QQ
A P-Interval is a moderate-or-severe COPD exacerbation instance from a single CRF page.
An I-Interval is an overarching mild-moderate-or-severe COPD exacerbation event based on e-diary 
symptom data.
A QQ-Interval is an overarching mild-moderate-or-severe COPD exacerbation event – encompassing 
multiple P-Intervals and I-Intervals – incorporating both CRF data and e-diary symptom data.
In summary, we combine CRF based moderate-or-severe COPD exacerbation events (or severe
COPD exacerbation events) if they are close enough together in time (Figure 2). We also 
combine mild-moderate-or-severe COPD exacerbations if they are close enough together in time; 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 49 of 115)
this coalescing is done first within-data-source (CRF [Figure 2] or diary [Figure 3]) and then 
between the two sources (Figure 4).
Time-at-Risk for COPD Exacerbations of Various Severities: Operational Definition
During a time when a subject is not experiencing a severe COPD exacerbation (i.e. QS interval) 
– and is not in the seven days following a severe COPD exacerbation – a subject is considered to 
be at risk of having a severe exacerbation. During a time when a subject is not experiencing a 
moderate-or-severe COPD exacerbation (i.e. QMS interval) – and is not in the seven days 
following a moderate-or-severe COPD exacerbation – a subject is considered to be at risk of 
having a moderate-or-severe exacerbation. During a time when a subject is not experiencing an 
any-severity COPD exacerbation (i.e. QQ interval) – and is not in the seven days following an 
any-severity COPD exacerbation – a subject is considered to be at risk of having an any-severity 
exacerbation.
Overarching coalesced intervals (i.e. events) of COPD exacerbation will be listed for severe 
exacerbations, moderate -to-severe exacerbations, and any-severity exacerbations (Listing 
6.1.2.3). A severe COPD exacerbation event must be classified also as a moderate-or-severe 
event and also as an any-severity event. A moderate-or-severe COPD exacerbation event must be 
classified also as an any-severity event.
Rate of COPD exacerbations of any severity will be analyzed in a manner similar to the rate of 
moderate or severe COPD exacerbations (Table 2.8.10 for the efficacy estimand).
The count of COPD exacerbations of any severity is the number of QQ-Intervals (for a subject) 
as defined previously. Time at risk of experiencing an exacerbation will be used as an offset 
variable in the model. Time during an exacerbation (of any severity) or in the 7 days following 
an exacerbation (of any severity) will not be included in the calculation of exposure (i.e. time at 
risk). Data related to COPD exacerbations of any severity are listed in Listings 6.1.2.1, 6.1.2.2, 
6.1.2.3, and 6.1.4. For moderate-or-severe COPD exacerbations that were identified apart from 
an eDiary alert, the symptom information is listed in Listing 6.1.2.2.
Time to First COPD Exacerbation of any Severity
6.4.6.3
Time to first COPD exacerbation of any severity will be analyzed and graphically displayed 
using a similar approach as for time to first moderate or severe COPD exacerbations (Table and 
Figure 2.8.5 for the efficacy estimand).
Time to First Severe COPD Exacerbation
6.4.6.4
Time to first severe COPD exacerbation will be analyzed and graphically displayed using a 
similar approach as for time to first moderate or severe COPD exacerbations (Table and Figure 
2.8.6 for the efficacy estimand).


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 50 of 115)
Time to First COPD Exacerbation Treated with Systemic Steroids
6.4.6.5
Time to first COPD exacerbation treated with systemic steroids will be analyzed and graphically 
displayed using a similar approach as for time to first moderate or severe COPD exacerbations 
(Table and Figure 2.8.7 for the efficacy estimand).
Time to First COPD Exacerbation Treated with Antibiotics
6.4.6.6
Time to first COPD exacerbation treated with antibiotics will be analyzed and graphically 
displayed using a similar approach as for time to first moderate or severe COPD exacerbations 
(Table and Figure 2.8.8 for the efficacy estimand).
Time to Treatment Failure
6.4.6.7
Treatment failure is defined as a moderate or severe COPD exacerbation or discontinuation from 
treatment for any reason or death. Time to treatment failure will be displayed graphically for 
each treatment group using a Kaplan-Meier curve and analyzed using a log-rank test to compare 
the curves between the treatments (Figure 2.9.1 for the efficacy estimand). Subjects who do not
experience a treatment failure will be censored at Day 365 or the End of Study day whichever 
comes first. The time to treatment failure will be analyzed using the efficacy estimand. The 
model will include treatment, baseline post-bronchodilator percent predicted FEV1, baseline 
EORRGHRVLQRSKLOFRXQWEDVHOLQH&23'H[DFHUEDWLRQKLVWRU\DQG,&6XVHDW6FUHHQLQJ
(yes/no). Estimated adjusted hazard ratios will be displayed along with associated 95% CI and p-
values (Table 2.9.1 for the efficacy estimand).
Time to Death: All Causes, Respiratory
6.4.6.8
The primary analysis will use the treatment policy estimand. Time to death (all causes) in weeks 
will be summarized using a Kaplan-Meier curve. Subjects who do not die will be censored at the 
day of last contact or confirmed vital status. A Cox regression model will be used to compare the 
treatments and include treatment, baseline post-bronchodilator percent predicted FEV1, and 
baseline age. Estimated adjusted hazard ratios will be displayed along with associated 95% CI 
and p-values (Table and Figure 2.10.1 for the treatment policy estimand).
Data permitting, these analyses will be repeated for time to death from respiratory causes. Only 
those deaths identified as being due to respiratory causes by the Clinical Endpoint Committee 
will be considered as events for this analysis. In addition to the censoring rules above, subjects 
who die from non-respiratory causes will be censored at the day of death. Estimated adjusted 
hazard ratios will be displayed along with associated 95% CI and p-values (Table and Figure 
2.10.2 for the treatment policy estimand).
The analysis of time to death will be conducted contingent upon having at least 30 events of 
death. Otherwise, the analysis will be limited to counts and listings.
Time to First Sustained Clinically Important Deterioration
6.4.6.9
6XVWDLQHG&,'LVGHILQHGDVP/decrease from baseline in trough FEV1RUSRLQWV
increase from baseline in SGRQ total score, or a TDI focal score of -1 point or less, any of which 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 51 of 115)
has occurred RQWZRFRQVHFXWLYHDQDO\VLVYLVLWVRUIRURIDOODYDLODEOHVXEVHTXHQWDQDO\VLV
visits, or a treatment emergent moderate-or-severe COPD exacerbation occurring up to Week 52. 
Time to sustained CID is an “other” endpoint.
The number of subsequent scheduled visits is determined based on the remaining visits that a 
given patient is expected to complete before End of Study occurs (see section 6.4.3 for the 
planned last visit definition).
Time to sustained CID will be analyzed by a Cox model, which will include treatment, baseline 
post-bronchodilator percent predicted FEV1, baseline blood eosinophil count, baseline COPD 
H[DFHUEDWLRQKLVWRU\Dnd ICS use at Screening (yes/no). Time to a sustained CID event 
will be based on the component event which occurs first. Subjects who do not experience a 
sustained CID event will be censored at the earliest day among the component censoring times. 
COPD exacerbations happening after Week 52 will not be counted as sustained CID events. 
Estimated adjusted hazard ratios will be displayed along with associated 95% CI and p-values 
(Tables 2.11.4 for the efficacy estimand). Time to a sustained CID will be displayed graphically 
for each treatment group using a Kaplan-Meier curve and analyzed using a log-rank test to 
compare the curves between the treatments (Figure 2.11.4 for the efficacy estimand).
Subjects who do not experience a sustained CID exacerbation and complete the study will be 
censored at the date of study completion. For the efficacy estimand, subjects who discontinue 
study treatment early without experiencing a sustained CID will be censored at the date of last 
study drug dose.
European Quality-of-Life-5 Dimension-5 Level Questionnaire (EQ-5D-5L)
6.4.6.10
The European Quality-of-Life-5 Dimension-5 Level Questionnaire (EQ-5D-5L) data will be 
weighted to calculate an index score based upon subjects’ responses to the 5 dimensions. The 
visual analogue scale (VAS) will be scored from 0 (worst imaginable health state) through 100 
(best imaginable health state) to represent the subject’s self-report concerning how bad or how 
good their health was during that day.
EQ-5D will be presented in three different ways: 
1. Presenting results from the EQ-5D-5L descriptive system as a health profile at baseline, at all 
visits, and at EoT (%, n) by domain 
2. Presenting results of the VAS as a measure of overall self-rated health status - baseline scores, 
scores at each visit, changes from baseline at each visit, and mean VAS score over the treatment 
period
3. Presenting results from the EQ-5D-5L index score (using UK value set) baseline, each visit, 
changes from baseline to each visit, and the mean index score over the treatment period. 
The percentage of subjects’ categorical responses to each of the 5-dimensions will be 
summarized (Table 2.12.1 for the efficacy estimand). Descriptive statistics for the index score 
(Table 2.12.2 for the efficacy estimand) and VAS (Table 2.12.3 for the efficacy estimand) will 
be presented by treatment group. VAS scores over 24 weeks may be analyzed using a similar 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 52 of 115)
RM model as is used for the TDI, but using baseline EQ-5D VAS score as a covariate instead of 
BDI (Table and Figure 2.12.2 for the index score and Table 2.12.3 for VAS for the efficacy 
estimand). EQ-5D data are listed in Listing 6.1.10.
For calculations of index score, the method recommended by the national institute for health and 
care excellence (NICE) August 2017 will be applied. Cross-walk between EQ-5D-3L value set 
and EQ-5D-5L descriptive system have been developed by Van Hout et al 2012 (Van Hout et al.
2012) and this cross-walk value set for EQ-5D-5L will be used to calculate the index score (Van 
Reenan 2015). Appendix 8 contains the SAS/SPSS codes for crosswalk between 5L and 3L for 
calculation of index score.
No imputation will be made for missing data in either the EQ-5D-5L or VAS responses. 
The compliance of completing the EQ-5D-5L questionnaires is a critical issue in the QoL and 
health-state evaluation, and will be described by post-randomization visit, by displaying the 
number and percentage of subjects who were assessed (per subject, at least 1 question answered) 
at each visit (Table 2.12.4 for the efficacy estimand).
Subgroup Analyses
6.4.7
Subgroup analyses will be performed for change from baseline in morning pre-dose trough 
FEV1, and rate of moderate or severe COPD exacerbations (efficacy estimand only). The 
following subgroups will be considered:
x
History of Moderate or Severe COPD Exacerbation in the last 12 Months:
o
1
o

x
Baseline Eosinophil Count:
o
<150 cells per mm3
o
FHOOVSHUPP3
x
Country
Each subgroup will be analyzed separately using the same model that was used for the overall 
(combined subgroups) analysis. Estimates for the treatment effect and for the treatment 
differences will be displayed in the efficacy endpoint tables for each subgroup (Tables 4.1.1 to
4.2.3).
For each subgroup analysis, a test for the treatment-by-subgroup interaction will be performed 
using the same model that was used for the overall (combined subgroups) analysis but with the 
addition of terms for subgroup and the treatment-by-subgroup interaction. A table will be 
provided with the p-value for the test of the treatment-by subgroup interaction (Table 4.3 for the 
efficacy estimand).


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 53 of 115)
Eosinophil Cut Point Exploration
Subgroup analyses of trough FEV1 will be conducted in the baseline eosinophil count-KLJK
cells per mm3) and the baseline eosinophil count-low (<150 cells per mm3) subgroups. It is 
acknowledged 150 cells per mm3 may not ultimately be the appropriate threshold for evaluation 
of treatment benefit. Thus, additional analyses will evaluate alternative thresholds, and the 
results from these analyses could then inform thresholds for future clinical studies. This 
exploration will include using additive mixed models that combine nonparametric regression for 
the relationship of eosinophil levels to trough FEV1 (Figures 4.4.1, and 4.4.1.1 for trough FEV1
at Week 12, and Figures 4.4.2, and 4.4.2.1 for trough FEV1 Over 24 Weeks) as well as 
potentially using subgroups defined by different cut points. A similar subgroup analysis will also 
be conducted for the rate of moderate or severe COPD exacerbations (Figures 4.4.3 and 4.4.3.1).
Control of Type I Error
6.4.8
The same general Type I error control strategy will be employed for the US and Ex-US 
regulatory approaches. In each approach, Type I error will be controlled for the following 
analyses:
x
The primary analyses for the efficacy estimand
x
The secondary analysis of the primary endpoints for the attributable estimand
x
The secondary analyses 
x
A subgroup analysis of patients with 2 or more moderate or severe COPD exacerbations in 
the previous 12 months
US Approach
6.4.8.1
The Type I error rate will be controlled within the primary, secondary, and subgroup efficacy 
analyses. The primary analyses associated with BFF MDI 160/9.6 will proceed only if the 
primary analysis associated with BFF MDI 320/9.6 is successful. The analysis of the primary 
endpoint for the attributable estimand, secondary analyses, and subgroup analysis for each BFF 
dose will proceed only if the primary analysis associated with that dose of BFF MDI is 
successful. 
For ease of review, the set of planned analyses has been divided into two groups:
Group 1: The primary analyses under the efficacy estimand and the analysis of the primary 
endpoints for the attributable estimand. 
Group 2: The secondary and subgroup analyses under the efficacy estimand. 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 54 of 115)
Figure 5
Group 1: Type I Error Control for the Analyses of the Primary Endpoints (US 
Approach)
In Group 1, a sequential multiplicity approach will be used in the analyses of the primary 
endpoint. In this approach, the analyses of the primary endpoint are listed in a pre-specified order 
in which they will be tested. Each hypothesis will be tested at the 2-sided 0.05 level. If a p-value 
is less than 0.05, then that hypothesis is rejected and the next hypothesis is tested. If the primary 
hypothesis is not rejected, then testing will stop. However, it is noted that p-values will still be 
calculated for all subsequent analyses for descriptive purposes.
Group 2 analyses are presented in Figure 6.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 55 of 115)
Figure 6
Group 2: The Analysis of the Secondary Endpoints (US Approach) 
In Group 2, the secondary analyses and the subgroup analysis will be treated as separate families 
of hypotheses. The Type I error in each family of secondary analyses will be controlled to alpha. 
Ex-US Approach
6.4.8.2
The Ex-US Approach will follow a similar general strategy as the US Approach. The control of 
Type I error in the Ex-US Approach differs from the US Approach in the number of secondary 
endpoints being evaluated. Otherwise, the Type I error control strategy is similar. The graphical 
representations of the primary, secondary, and subgroup analyses are presented below.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 56 of 115)
Figure 7
Group 1: Type I Error Control for the Analyses of the Primary Endpoints (Ex-US 
Approach)
If the Group 1 analyses are successful within a BFF MDI dose, the analysis of the secondary 
endpoints for that BFF MDI dose (Group 2) will proceed under the efficacy estimand.
Group 2 analyses are presented in Figure 8.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 57 of 115)
Figure 8
Group 2: The Analysis of the Secondary Endpoints (Ex-US Approach) 
Correlation Analysis
6.4.9
Pearson correlation coefficients will be generated between the primary and secondary continuous 
endpoints (from both US and ex-US approaches). SGRQ total score will be used in place of the 
SQRQ responder. The mITT population will be used. 
Note that for morning trough FEV1, TDI, and change from baseline in SGRQ, the estimates over 
24 weeks were obtained as LS means from MMRM analyses, and were not derived at the subject 
level. For the purpose of the correlation analysis, the endpoints over 24 weeks will be 
represented by simple averages of available data over 24 weeks.
The correlations will be organized in a matrix, with its upper triangle filled with pairwise 
Pearson correlation coefficients. All treatment groups will be pooled (Table 2.13.1), and also 
analyzed individually (Tables 2.13.2 to 2.13.4).
6.5
Safety Analysis
All safety analyses are based on the Safety Population. Hypothesis testing will not be performed 
for any safety analyses.
All AE data, clinically significant laboratory values, vital signs, and ECG values will be 
categorized according to their onset date into the following study periods:
x
Events occurring during the treatment period (referred to as “On-Treatment” or “treatment-
emergent”) are events with an onset date on or after the first date of dose and up to and 


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
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including the last day of randomized treatment (for study drug completers) or the last day of 
randomized treatment + 1 day (for premature treatment discontinuation). Events known to 
have occurred before the time of the first dose of study treatment are not included. 
x
Events occurring during the post-treatment-discontinuation follow-up are events with an 
onset date after the last day of randomized treatment (for study drug completers) or on or 
after the last day of randomized treatment + 2 days (for premature treatment discontinuation). 
The exception is that deaths are still considered to be during the Treatment Period if any 
adverse event that led to that death is during the Treatment Period.
Any AEs, clinically significant laboratory values, vital signs, and ECG values during the 
randomized-treatment period will be tabulated and listed. Beginning on the day after the date of 
discontinuation from or completion of study medication has passed, any new clinically 
significant ECGs, laboratory values, and vital signs will not be included in the tabulation or the 
computation of incidence rates, but will still be listed. Any new AEs, SAEs, and deaths during 
the post-randomized-treatment maintenance period will be tabulated and listed.
Adverse Events
6.5.1
The version of the Medical Dictionary for Regulatory Activities (MedDRA) that is current at the 
time of database lock will be used to code verbatim terms for AEs for final analysis of the data. 
A glossary of MedDRA preferred terms used for adverse events reported in the study along with 
the associated Investigator’s verbatim will be provided in Listing 7.2.
An AE is considered treatment-emergent if an event occurs after the first dose of randomized 
study medication in the study, or if the AE worsened during the study after the first dose of study 
medication in the study (intensity and/or severity changed to a worsened grade), and the event 
onset is on or before the date of discontinuation from or completion of randomized study 
medication. Adverse events with onset date after the date of discontinuation from or completion 
of randomized treatment will not be considered treatment-emergent, but will be listed in adverse 
event data listings, and will be tabulated separately. Adverse events that occur between the time 
the subject signs the informed consent form for the study and the time when that subject is 
randomized are to be recorded as medical history unless the event met the definition of an SAE.
The incidence of an AE will be defined as the number and percentage of subjects experiencing 
an event. Adverse events will be tabulated at the level of the MedDRA preferred term and the 
MedDRA system organ class. No hypothesis tests will be performed.
An overview table will be prepared for the Safety Population with the incidences of subjects with 
at least one Treatment-Emergent Adverse Event (TEAE), at least one serious TEAE, at least one 
TEAE related to study treatment, at least one serious TEAE related to study treatment, at least 
one TEAE leading to premature treatment discontinuation, and a report of death (Tables 3.1.1, 
3.1.13, and 3.1.14).
Events with Irregular Onset Dates


Statistical Analysis Plan
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Date:  09 February 2018
(Page 59 of 115)
All TEAEs will be included in the data listings regardless of the completeness of the onset dates. 
Partial dates will be imputed in order to determine if an AE is treatment-emergent using the 
imputation rules in Appendix 1; however, imputed dates will not be provided in the data listings.
All adverse events, whether treatment-emergent or not, will be included in the listings. Reported 
adverse events by system organ class, preferred term, treatment, country, center, subject and 
onset day will be provided (Listing 7.1). Reported adverse events by treatment, country, center, 
subject, and onset date will be presented in Listing 7.3. SAE-specific report information will be 
listed in Table 3.8.2.1 and Table 3.8.2.2.
The listing of adverse events will provide the severity, maximum severity, relationship to study 
drug, action taken and outcome for each adverse event. Any SAEs reported will be listed for all 
subjects screened (Tables 3.8.2.1). Adverse events leading to permanent discontinuation of study 
treatment will be listed for the Safety Population (Table 3.6.1). A listing of any reported deaths 
during the study (prior to randomization, during the randomized-treatment period, or during the 
post-randomized-treatment maintenance period) will be provided (Table 3.15.2.1); study 
treatment taken prior to the death and the number of days since the last dose of this study 
treatment at the time of the death will be included in the listing. 
Summary tabulations of the following will be prepared for all subjects, for each treatment, for 
each primary system organ class, and for each preferred term within a system organ class:
x
The incidence of all treatment-emergent adverse events (Tables 3.2.1.1, 3.2.1.2, Table 
3.2.1.3)
x
The incidence of subjects with adverse events by SOC during the post-randomized-treatment 
maintenance period (Tables 3.2.1.18, 3.2.1.19)
x
The incidence of treatment-emergent adverse events occurring in SMQs (Standard MedDRA 
Queries)/groupings of interest (Tables 3.2.3.1, 3.2.3.2)
x
The incidence of non-serious treatment-HPHUJHQWDGYHUVHHYHQWVRFFXUULQJLQRI
subjects in a treatment (Tables 3.2.4.1, 3.2.4.2)
x
The incidence of all treatment-related treatment-emergent adverse events (Tables 3.4.1, 
3.4.2)
x
The incidence of discontinuation from study treatment due to a treatment-emergent adverse 
events (Tables 3.5.1, 3.5.2)
x
The incidence of treatment-emergent serious adverse events (Tables 3.7.1.1.1, 3.7.1.1.2, 
3.7.1.1.3)
x
The incidence of subjects with serious adverse events by SOC during the post-randomized 
treatment maintenance period ((Tables 3.7.2.3, 3.7.2.4)


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Date:  09 February 2018
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x
The incidence of all treatment-related treatment-emergent serious adverse events (Tables 
3.9.1, 3.9.2)
x
The incidence of all treatment-emergent adverse events by highest severity to treatment 
(Tables 3.11.1.1 through 3.11.4.2 for the four treatments)
x
The incidence of treatment-emergent adverse events occurring in at least 2% of subjects in 
any treatment (Tables 3.2.2.1, 3.2.2.2 sorted by descending frequency of events in a preferred 
term).
x
In addition, to control for possible differences in exposure between the treatments, the 
following AE and SAE summaries will be presented with the frequency and rate of 
occurrence (total number of events per 1000 person-years of exposure) by treatment, primary 
system organ class, and preferred term:
o
Frequency and rate of AEs (Tables 3.3.1, 3.3.2)
o
Frequency and rate of SAEs (Tables 3.8.3.1, 3.8.3.2)
o
Frequency and rate of neoplasms (Tables 3.10.3.1 and 3.10.3.2 – All Cancer, 3.10.4.1 and
3.10.4.2 - Excluding Non-Melanoma Skin Cancer).
Adverse Events of Special Interest
6.5.1.1
Adverse events of special interest (AESIs) have been defined based on known effects of LABAs 
and ICS. These include but are not limited to cardiovascular, tremor effects, hyperglycemia, and 
hypokalemia for LABAs; and local (e.g., candidiasis and voice effects) and systemic (e.g., bone 
and skin effects, diabetes control, ocular and taste effects, adrenal suppression) steroid class 
effects and lung infection for ICS. 
Standardized MedDRA queries (SMQs) will be utilized when possible, and a selection of high-
level group terms (HLGTs), high-level terms (HLTs), and PTs will be utilized to represent other 
situations. The terms proposed to be used in the assessment of AESIs associated with ICS and 
LABAs are listed in Table 6. SMQs will be utilized when possible and a selection of preferred 
terms in other situations (Appendix 5).
Table 6
Adverse Events of Special Interest
Medical Concept
Selection of MedDRA Terms
Adrenal suppression
Adrenal cortical hypofunctions HLT
Agitation or anxiety
Collection of PTs
Bone fracture
Collection of HLGTs, HLTs, and PTs.
Candidiasis 
Collection of PTs
Cardiovascular
Cardiac arrhythmias SMQ
Cardiac failure SMQ
Ischemic heart disease SMQ
Torsades de Pointe/QT prolongation SMQ


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Medical Concept
Selection of MedDRA Terms
Cardiovascular death
Collection of PTs
Cerebrovascular condition
CNS haemorrhages and cerebrovascular conditions 
SMQ
Diabetes mellitus
Hyperglycaemia/new onset diabetes mellitus SMQ
Dysgeusia or ageusia
Collection of PTs
Dysphonia or aphonia
Collection of PTs
Gastrointestinal
Gastrointestinal perforation, ulceration, haemorrhage 
or obstruction SMQ
Gastrointestinal obstruction SMQ
Headache 
Headache (PT)
Hypercortisolism
Collection of PTs
Hypertension
Blood pressure ambulatory increased (PT)
Blood pressure increased (PT)
Blood systolic increased (PT)
Hypokalemia
Collection of PTs
Lower respiratory tract infections other than 
pneumonia
Bronchitis (PT)
Bronchitis viral (PT)
Bronchitis bacterial (PT)
Lower respiratory tract infection (PT)
Lower respiratory tract infection viral (PT)
Lower respiratory tract infection bacterial (PT)
Infective exacerbation of chronic obstructive airway 
disease (PT)
Ocular effects
Visual disorders HLT
Glaucoma SMQ
increased intraocular pressure collection of PTs
Cataract collection of PTs
Osteoporosis and osteopenia
Osteoporosis/osteopenia (SMQ)
Palpitation
Palpitations PT
Paradoxical bronchospasm
Collection of PTs
Pneumonia 
Collection of PTs
Psychiatric effect
Collection of PTs
Skin effects
Skin atrophy (PT)
Skin striae (PT) 
Acne (PT) 
Contusion (PT) 
Ecchymosis (PT) 
Increased tendency to bruise (PT) 
Petechiae (PT) 
Purpura (PT) 
Malassezia folliculitis (collection of PTs) 
Hypertrichosisa (collection of PTs) 
Alopecia (collection of PTs)


Statistical Analysis Plan
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Date:  09 February 2018
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Medical Concept
Selection of MedDRA Terms
Sleep effects
Initial insomnia (PT)
Insomnia (PT)
Sleep disorder (PT)
Sudden death
Collection of PTs
Throat irritation
Collection of PTs
Tremor
Tremor HLT
Weight gain
Collection of PTs
Abbreviations: CNS=central nervous system; PT=preferred term.
Adverse Events in MedDRA SMQs/Groupings of Interest by Term will be tabulated (Tables 
3.12.1, 3.12.2).
Major Adverse Cardiovascular Event (MACE) Events Determined by 
6.5.1.2
Clinical Endpoint Committee
The clinical endpoint committee (CEC) will review and adjudicate serious Cardio- and 
Cerebrovascular (CCV) events as MACE. MACE events are defined as the following:
x
Cardiovascular death
x
Non-fatal myocardial infarction (MI)
x
Non-fatal stroke
The CEC will review and assess these non-fatal serious CCV events and all deaths as to whether 
or not they fulfill criteria (based on CEC working practices) for MACE.
MACE events will be summarized by adjudicated CRF category and treatment group (Tables 
3.13.1.1, 3.13.1.2). The assessment of MACE events will include the rate of confirmed MACE 
events (Tables 3.13.2.1, 3.13.2.2). Adjudicated MACE events will be listed in Listing 7.4.
The incidence of subjects with adjudicated MACE AEs by category will be summarized in Table 
3.13.3.1 and Table 3.13.3.2.
Pneumonia Events Determined by Clinical Endpoint Committee
6.5.1.3
All AEs/SAEs with preferred terms that could relate to pneumonia will be adjudicated to provide 
a more complete assessment of all physician-reported pneumonias. The incidence of confirmed 
pneumonia events will be tabulated (Tables 3.14.1.1, 3.14.1.2). The assessment of pneumonia 
events will include the rate of confirmed pneumonia events (Tables 3.14.2.1, 3.14.2.2). 
Adjudicated pneumonia events will be listed in Listing 7.4.
In order to account for specific patient risk factors, data permitting, time to first pneumonia will 
be compared between treatments using Cox proportional hazards (Tables 3.14.3.1, 3.14.3.2). 


Statistical Analysis Plan
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Date:  09 February 2018
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Specific patient risk factors (baseline FEV1, age, and medical history of pneumonia in the last 5 
years [Yes or No]) will be evaluated for inclusion.
The incidence of subjects with adjudicated pneumonia AEs by category will be summarized in 
Table 3.13.3.1 and Table 3.13.3.2.
Cause of Death Determined by Clinical Endpoint Committees
6.5.1.4
Causes of death will be listed by subject and summarized by treatment for (1) all-cause mortality, 
(2) mortality of probable cardiovascular cause, (3) mortality of probable respiratory cause, (4) 
mortality of cancer and (5) mortality of probable other causes using the Safety Population based 
on (A) cases reported during the active Treatment Period and (B) cases reported during the active 
Treatment Period plus one day (Tables 3.15.2.1 and 3.15.2.2). The incidence of subjects with a
death event will be tabulated by adjudicated CRF category and treatment during the randomized-
treatment period (Tables 3.15.1.1, 3.15.1.2) and during the post-randomized-treatment 
maintenance period (Tables 3.15.1.3 and 3.15.1.4). To control for possible differences in 
exposure between treatments, the death will be summarized with frequency and rate of 
occurrence (total number of events per 1000 person-years of exposure) by treatment, primary 
system organ class, and preferred term (Tables 3.15.3.1, 3.15.3.2). Adjudicated death events will 
be listed in Listing 7.4.
Paradoxical Bronchospasms
6.5.1.5
All paradoxical bronchospasm events will be captured on the AE CRF page. Paradoxical 
bronchospasms will be summarized by treatment during the randomized-treatment period (Table 
3.2.3).
Clinical Laboratory Measurements
6.5.2
Lab parameters collected include the following:


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Table 7
Lab Parameters
Hematology
Hemoglobin 
Mean corpuscular 
hemoglobin 
Hematocrit 
Mean corpuscular 
hemoglobin concentration 
White blood cell count with differential 
Mean corpuscular 
volume 
Red blood cell count 
Eosinophils
Platelet count 
Clinical Blood Chemistry
Liver Enzyme and Other Liver Function Tests
Other Clinical Blood 
Chemistry
Alanine aminotransferase (ALT)
Albumin
Aspartate aminotransferase (AST)
Blood Urea Nitrogen 
(BUN)
Alkaline phosphatase 
Calciuma
Bilirubin, total 
Chloridea
Gamma-glutamyl transferase 
Cholesterol 
Bicarbonate
Creatininea
Glucosea
Magnesium 
Potassiuma
Phosphate
Protein, total 
Sodiuma
Triglycerides 
Urinalysis
Macroscopic examination including specific gravity, pH, protein, glucose, ketones, blood, and 
urobilinogen.
Other Tests:
Pregnancy test (women of childbearing potential only): serum hCG at Visit 1 (Screening) and
Visit 13 (Week 52 or Final Study Visit) or Treatment Discontinuation/Study Withdrawal Visit
Creatinine clearance will be estimated by the CKD-EPI formula [Levey, 2009].
Abbreviations: CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration; hCG=human chorionic 
gonadotropin
a Parameters included in the Basic Metabolic Panel.


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Date:  09 February 2018
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A Clinically Significant Laboratory Abnormality as identified by the Investigator after the 
start of study treatment will be recorded as an Adverse Event and tabulated as an AE in the AE 
analysis. Abnormalities occurring prior to the start of treatment will be noted in medical history 
and presented in a data listing. Per protocol, the criteria for a "clinically significant" laboratory 
abnormality are:
x
A laboratory abnormality that leads to a dose-limiting toxicity (e.g., an abnormality that 
results in study drug dose reduction, suspension or discontinuation)
x
A laboratory abnormality that results in any therapeutic intervention (i.e., concomitant 
medication or therapy)
x
Other laboratory abnormality judged by the Investigator to be of any particular clinical 
concern (e.g., significant fall in hemoglobin not requiring transfusion)
All laboratory data will be stored in the database with the units in which they were originally 
reported. Laboratory data not reported in International System of Units (SI units; Système 
International d’Unités) will be converted to SI units before data analysis.
Individual clinical laboratory variables for hematology and clinical chemistry and kidney 
function, including creatinine clearance, will be provided in listings (Listing 8.1 for hematology,
Listing 8.2 for blood chemistry and kidney function, Listing 8.3 for urinalysis, and Listing 4.6 for 
pregnancy test results at screening and after the start of treatment). Data will be listed in SI units 
where available. Comments for laboratory testing will be listed (Listing 8.4). For listings, 
laboratory values will be flagged as Low or High based on the reference ranges provided by the 
central laboratory, Covance (Appendix 4).
The baseline measurement for a laboratory parameter will be the last available measurement 
prior to the start of dosing.
If there are multiple laboratory values for the same parameter at pre-dose of a visit, the last value 
will be chosen for analysis.
Summary statistics (n, mean, median, standard deviation, minimum, and maximum) for the 
baseline assessment and for the pre-dose value and change from baseline at each post-baseline 
visit and end of treatment for scheduled lab assessments of continuous laboratory variables 
including serum potassium and glucose will be tabulated. “End of Treatment” is defined as the 
last non-missing assessment during the treatment period. Data from unscheduled visits will not 
be used for the by-visit summaries but both scheduled and unscheduled-visit are candidates for 
clinically significant values, for the end-of-treatment summary, and for shift tables. Data from 
both scheduled and unscheduled visits will be listed. The summaries will be provided by 
treatment (Tables 3.16.1 through 3.16.4, for hematology, blood chemistry, kidney function, and 
urinalysis, respectively). Shift tables will be produced using the categories defined by the 
Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 grades for the Safety 
Population (Tables 3.16.5 to 3.16.8) for hematology, chemistry, kidney function and urinalysis, 


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Date:  09 February 2018
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respectively) for hematology, chemistry, kidney function and urinalysis, respectively). For these 
shift tables, for each treatment, the subject’s pre-dose grade will be cross-tabulated by the 
subject’s maximum post-baseline grade during the treatment; also, the subject’s maximum post-
baseline grade during treatment will be tabulated for all baseline grades combined. Percentages 
of subjects in each maximum post-baseline grade for a treatment will be calculated for each pre-
dose grade for the treatment and also for all baseline grades combined. Laboratory abnormal 
values on-treatment will be flagged as High or Low values based on laboratory reference ranges 
provided by Covance (found in Appendix 4) as per Pearl, Inc. These flags along with the 
reference ranges will be provided in the laboratory data listings.
Potentially Clinically Significant Laboratory Values Above/Below a Clinically Relevant 
Threshold on-treatment, based on CTCAE 4.03 and other criteria, will be identified based on the 
following thresholds:
Table 8
Potentially Clinically Significant (PCS) Laboratory Parameter Criteria
Parameter
Post-Baseline Criteria
Hematology
Hemoglobin 
<8.0 g/dL (<80 g/L)
Increase of >40 g/L to a value above the ULN 
(upper limit of normal)
White Blood Cell Count
<2000/μL 
>35,000/μL
Platelet Count
<50,000/μL
>999,000/μL 
Chemistry
eGFR-EPI 
<30 mL/min/1.73 m2
AST
>3 x ULN
ALT
>3 x ULN
Alkaline Phosphatase
>5 x ULN
Total Bilirubin
>2 x ULN
Blood Glucose* (random values)
<2.2 mmol/L (<39.6 mg/dL)
>13.9 mmol/L (>250 mg/dL) if baseline is 
below 10.0 mmol/L (180 mg/dL), >16.7 
mmol/L (>300 mg/dL) if baseline is greater 
than 10.0 mmol/L (180 mg/dL).
Serum Potassium
<3.0 mmol/L
>6.0 mmol/L
*CTCAE 4.03 criteria are based on fasting glucose values. However, subjects were not required 
to fast prior to obtaining blood glucose values.
Potentially clinically significant laboratory values will be tabulated for the Safety Population 
(Table 3.16.9).


Statistical Analysis Plan
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Date:  09 February 2018
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Since a reduction in potassium and an increase in blood glucose are known class effects of 
beta-agonists, all potassium or glucose assessments for subjects who experienced newly 
occurring or worsening potentially clinically significant values after start of the study treatment 
will be provided in separate listings (Tables 3.16.10 to 3.16.11). For all laboratory parameters 
other than glucose and potassium noted in Table 7, all laboratory data for the parameter 
identified as potentially clinically significant for a subject will be listed (Table 3.16.12- Safety 
Population).
Vital Signs
6.5.3
Changes from Baseline in on-treatment supine or seated systolic blood pressure, supine or 
seated diastolic blood pressure, and heart rate will be evaluated, where baseline is defined as the 
average of all available pre-dose measurements taken prior to the start of dosing at the 
Randomization Visit (Visit 3). If there are no Visit 3 pre-dose values, the baseline will be defined 
as the average of pre-bronchodilator values at Visit 2. No Hypothesis testing will be performed.
A Clinically Significant Abnormality in vital signs identified by the Investigator will be 
recorded as an Adverse Event if it occurs after the start of treatment. These adverse events will 
be included in the AE summaries; abnormalities prior to the start of treatment will be noted in 
medical history and listed.
Potentially clinically significant changes in systolic and diastolic blood pressure will be 
defined based on the following criteria provided by Pearl, Inc.:


Statistical Analysis Plan
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Date:  09 February 2018
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Table 9
Potentially Clinically Significant Criteria for Systolic and Diastolic Blood Pressure 
Parameters
Parameter (mmHg)
Post-Baseline Criteria
Systolic Blood Pressure, increase
DQGLQFUHDVHIURPEDVHOLQH
Systolic Blood Pressure, decrease
DQGGHFUHDVHIURPEDVHOLQH
Diastolic Blood Pressure, increase
DQGLQFUHDVHIURPEDVHOLQH
Diastolic Blood Pressure, decrease
DQGGHFUHDVHIURPEDVHOLQH
PCS changes in heart rate will be assessed as follows:
Table 10
Potentially Clinically Significant Criteria for Heart Rate Parameters
Parameter
Post-Baseline Criteria
Tachycardia Event
ESPDQGLQFUHDVH from baseline
Bradycardia Event
ESPDQGGHFUHDVHIURPEDVHOLQH
Vital sign measurements (Heart rate, systolic blood pressure, diastolic blood pressure and body 
temperature, weight, height) during the study will be displayed in a vital signs listing 
(Listing 9.1).
A summary of baseline weight, height, and BMI will be presented by treatment (Tables 1.4.1 to 
1.4.4 for the mITT, RVU, and Safety Populations, and all subjects not randomized, respectively).
Summary statistics (n, mean, median, standard deviation and range) of the absolute value and 
change from baseline for systolic blood pressure, diastolic blood pressure, and heart rate will be 
tabulated by treatment, visit, and time point. These summaries (Table 3.17.1.1, Table 3.17.1.2)
will be prepared for baseline and each scheduled post-baseline nominal time point at each 
scheduled post-baseline visit and end of treatment. End of Treatment will be summarized for 
each scheduled post-baseline time point (pre-dose 1 hr, and post-dose 30 minutes and 4 hours). 
“End of Treatment” for each of these assessment points is defined as the last non-missing 
on-treatment assessment available for the time point. Data from unscheduled visits will not be 
used for the by-visit summaries but both scheduled and unscheduled-visit data are candidates for 
clinically significant values and for the end-of-treatment summary. Data from both scheduled 
and unscheduled visits will be listed. Time windows will be derived for each post-baseline 
visit using the time intervals for the study time windows detailed in Table 11. No hypothesis 
tests will be performed.


Statistical Analysis Plan
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Date:  09 February 2018
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Table 11
Analysis Study Time Windows for Vital Signs Assessments
Calculated Study Time Window
Time Interval for the Study Time Window
Pre-dose 60 min.
PLQSULRUWRGRVH
Post-dose 30 min.
>0 to <75 min. post-dose
Note that minutes are rounded to the nearest whole number before applying time 
windows.
If there are multiple vital sign values for the same parameter at pre-dose assessments after Visit 3 
or within the same post-dose study time window at a visit, the last value will be chosen for 
analysis.
The percentage of subjects with potentially clinically significant values for vital signs at any time 
post-dose at a visit will be summarized by treatment based on the criteria in Table 9 and Table 10
(Table 3.17.2.1- Safety Population).
All vital sign assessments for subjects with potentially clinically significant values will be listed 
(Tables 3.17.3.1, 3.17.3.2, 3.17.4.1, Table 3.17.4.2).
12-Lead Electrocardiogram Measurements
6.5.4
Changes from baseline in Heart Rate, PR Interval, QRS Axis, QRS Interval, QT Interval and 
QTcF (Fridericia Corrected QT) interval will be calculated where baseline is defined as the average 
of the pre-dose measurements taken prior to the start of treatment at the randomization visit 
(Visit 3). If there are no Visit 3 pre-dose values, the baseline will be defined as the value 
obtained at Visit 1. The QTcF is defined as [QT/(RR1/3)]. Heart rate (bpm) is estimated as 
60,000/RR, where RR is in units of ms. These assessments will be tabulated for each treatment 
and assessment time. 
A Clinically Significant Abnormality for a 12-Lead ECG measurement identified by the 
Investigator as a clinically significant abnormality will be recorded as an Adverse Event if it 
occurred after the start of study treatment. These adverse events will be included in the AE 
summaries.
All 12-Lead ECG measurements for the Safety Population will be listed (Listing 9.2). Summary 
statistics (mean, median, standard deviation and range) for raw values and change from baseline 
values in Heart Rate, PR Interval, QRS Axis, QRS Interval, QT Interval and QTcF interval will 
be calculated. These assessments will be tabulated for each treatment and each scheduled 
nominal time point at each visit and at end of treatment (Table 3.18.1). End of Treatment is 
defined as the last non-missing on-treatment assessment available. Data from unscheduled visits 
will not be used for the by-visit summaries but both scheduled and unscheduled-visit data are 
candidates for clinically significant values and for the end-of-treatment summary. Data from 
both scheduled and unscheduled visits will be listed. Mean pre-dose change from baseline for 
heart rate and QTcF will be plotted across post-baseline visits by treatment (Figures 3.18.1 to 


Statistical Analysis Plan
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Date:  09 February 2018
(Page 70 of 115)
3.18.5). ECG data from subjects with pacemakers will not be included in analyses, but will be 
listed.
If there are multiple ECG values for the same parameter at pre-dose of a visit date (other than for 
Visit 3), the last value will be chosen for analysis.
Other than for the change from baseline analyses mentioned above, all available data 
post-baseline including data from unscheduled visits will be used for ECG parameter analyses.
Table 12
Criteria for PCS ECG Values
Parameter 
Post-Baseline Criteria 
QTcF Prolongation 
PVHFLIPVHFDWVWXG\EDVHOLQHDQGPVHF
change from study baseline
PVHFLIPVHFDWVWXG\EDVHOLQHDQGPVHF
change from study baseline 
PVHFDQGPVHFFKDQJHIURPVWXG\EDVHOLQH
&KDQJHRIPVHFIURPVWXG\EDVHOLQHUHJDUGOHVVRILQLWLDO
value 
Potentially clinically significant ECG parameter values will be identified based on criteria listed 
in Table 12. The number and percentage of subjects who had such values observed any time 
post-dose will be tabulated for each treatment (Table 3.18.2) and listed (Table 3.18.3) for QTcF 
prolongation). No hypothesis tests will be performed.
Healthcare Resource Utilization
6.5.5
Data on healthcare resource utilization will be collected at all visits post-baseline and 
summarized by treatment group.
The following variables will be calculated unadjusted (per subject) over the entire Treatment 
Period and tabulated by actual treatment received for those subjects for whom they or one or 
more of their family members missed work:
x
The number of days missed work due to COPD.
x
The number of days that caregivers of subjects missed from work as a result of the subject’s 
COPD.
The following variables will be tabulated by actual treatment received and relationship to COPD 
(COPD-related, not COPD-related, and combined). The mean and the mean per person-year will 
be calculated across all subjects in a treatment.
x
The percentage of subjects with telephone calls to health-care providers:
o
Calls to any health-care provider (physician or other)
o
Calls to physician


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o
Calls to other health-care provider
x
The mean number of telephone calls to health-care providers:
o
Calls to any health-care provider (physician or other)
o
Calls to physician
o
Calls to other health-care provider
x
The percentage of subjects with visits to health-care providers:
o
Visits to any health-care provider (GP, specialist, or other)
o
Visits to GP
o
Visits to specialist
o
Visits to other health-care provider
x
The mean number of visits to health-care providers:
o
Visits to any health-care provider (GP, specialist, or other)
o
Visits to GP
o
Visits to specialist
o
Visits to other health-care provider
x
Ambulance Transport
o
The percentage of subjects who required ambulance transport
o
The mean number of times ambulance transport was required
x
ER Visits
o
The percentage of subjects with ER visits
o
The mean number of visits to ERs
x
Hospitalizations
o
The percentage of subjects hospitalized
o
The mean number of subject hospitalizations 
o
The mean number of days in the hospital
x
Hospitalizations with some time spent in the ICU or CCU
o
The percentage of subjects hospitalized with some time spent in the ICU or CCU
o
The mean number of subject hospitalizations with some time spent in the ICU or CCU
o
The mean number of days in the hospital with some time spent in the ICU or CCU
x
Hospitalizations with No time spent in the ICU or CCU
o
The percentage of subjects hospitalized with No time spent in the ICU or CCU
o
The mean number of subject hospitalizations with No time spent in the ICU or CCU


Statistical Analysis Plan
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Date:  09 February 2018
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o
The mean number of days in the hospital with No time spent in the ICU or CCU
x
ICU
o
The percentage of subjects in the ICU
o
The mean number of days in ICUs
x
CCU
o
The percentage of subjects in the CCU
o
The mean number of days in CCUs
Analyses will be performed using the mITT Population.
Descriptive statistics (n, mean, standard deviation, median, minimum and maximum) will be 
provided by actual treatment received for the number of days missed from work per year, the 
number of days that family members of subjects missed from work per year overall during the 
study (Table 3.20.1 and Listing 9.4).
Also, descriptive statistics will be provided by actual treatment received and relationship to 
COPD (related, not-related, and total) overall during the entire Treatment Period for the 
following variables: the number of telephone calls to health-care providers, the number of visits 
to health-care providers, the number of ER visits, the number of number of times ambulance 
transport was required, the number of subject hospitalizations, the number of days in the 
hospital, the number of days in the ICU, and the number of days in the CCU (Table 3.20.2 and 
Listings 9.4 and 9.5).
Physical Examination
6.5.6
Any physical examination abnormality reported after the start of treatment for a subject is to be 
reported as an adverse event. Thus, these will be included in listings of adverse events and 
summarized in adverse event summaries. Abnormalities seen at the Screening physical 
examinations will be recorded as Medical History and listed.
7.
CHANGES FROM METHODS PLANNED IN THE PROTOCOL 
The changes described in this section are discrepancies from protocol version 4.0 (Amendment 
3).
x
The Type I error control figure in the protocol for the ex-US approach (Protocol, Figure 9-4) 
incorrectly lists “RS-Total Score” as a secondary analysis.  It should be “EXACT-Total 
Score”.  The correction has been made to the figure in this SAP (Figure 8).
Any further changes to methods planned in this SAP will be documented in a revision to this 
statistical plan prior to database lock, or identified in the clinical study report.


Statistical Analysis Plan
Study:  PT009003 
Date:  09 February 2018
(Page 73 of 115)
8.
STATISTICAL SOFTWARE
Data processing, statistical screening, descriptive reporting and analysis of the efficacy and 
safety data will be performed using SAS (Version 9.3 or higher). Graphs may also be produced 
using R (R Development Core Team, 2003).
9.
REFERENCES
Carroll KJ, Fleming TR. Statistical Evaluation and Analysis of Regional Interactions: The 
PLATO Trial Case Study. Statistics in Biopharmaceutical Research 2013; 5:2, 91-101. DOI: 
10.1080/19466315.2013.783878
COPD Assessment Test (CAT) (http://www.catestonline.org/)
Cro, S (2017) Relevant Accessible Sensitivity Analysis for Clinical Trials with Missing Data. 
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