Clinical trial NCT02919995
Conditions: Cystic Fibrosis
Sponsor: Verona Pharma plc
Start date: 2017-02-08; Completion date: 2017-11-03
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluates two doses of RPL554 and placebo in adult patients with cystic fibrosis. All patients receive all three treatments in a randomised sequence.

Detailed description:

Arms: arm 1: Single dose of inhaled 6 mg RPL554 arm 2: Single dose of inhaled 1.5 mg RPL554 arm 3: Inhaled placebo dose
Interventions: intervention 1: RPL554 intervention 2: Placebo
Intervention descriptions: intervention 1: RPL554 suspension administered using a nebuliser intervention 2: Placebo solution administered using a nebuliser

Protocol documents:
Prot_002.pdf: 
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SAP_000.pdf: 


Verona Pharma plc  
 
 
SAP: RPL554-010-2015 
 
Date: 03Jan2018   
Page 2 of 22 
Version: Final 2.0 
 
 
Contents 
 
ABBREVIATIONS ................................................................................................................................... 3 
1 
INTRODUCTION ............................................................................................................................. 5 
2 
STUDY OBJECTIVES ..................................................................................................................... 5 
2.1 
Primary Objective........................................................................................................................ 5 
2.2 
Secondary Objectives ................................................................................................................. 5 
2.3 
Exploratory Objectives ................................................................................................................ 5 
3 
OVERALL STUDY DESIGN ............................................................................................................ 5 
3.1 
Overview of Study Design .......................................................................................................... 5 
3.2 
Withdrawals ................................................................................................................................ 6 
3.3 
Replacements ............................................................................................................................. 7 
4 
STUDY MEASUREMENTS AND VARIABLES ............................................................................... 7 
4.1 
Endpoints .................................................................................................................................... 7 
4.1.1 
Primary Endpoint ..................................................................................................................... 7 
4.1.2 
Secondary Endpoints ............................................................................................................... 7 
4.1.3 
Exploratory Endpoints .............................................................................................................. 7 
4.2 
Screening and Demographic Measurements ............................................................................. 7 
4.3 
Pharmacokinetic Measurements and Variables ......................................................................... 8 
4.4 
Pharmacodynamic Measurements and Variables ...................................................................... 8 
4.4.1 
Spirometry ............................................................................................................................... 8 
4.4.2 
Sputum Inflammatory Mediators .............................................................................................. 8 
4.4.3 
Exhaled Breath pH ................................................................................................................... 9 
4.5 
Safety Measurements and Variables .......................................................................................... 9 
4.5.1 
Adverse Events ........................................................................................................................ 9 
4.5.2 
Laboratory Safety Measurements and Variables .................................................................. 10 
4.5.3 
Vital Signs .............................................................................................................................. 11 
4.5.4 
Physical Examination ............................................................................................................. 11 
4.5.5 
12-Lead ECG ......................................................................................................................... 11 
5 
DATA MANAGEMENT .................................................................................................................. 11 
6 
STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE ...................................... 11 
6.1 
Statistical Evaluation ................................................................................................................. 11 
6.2 
Description of Analysis Sets ..................................................................................................... 11 
6.3 
Summary Statistics ................................................................................................................... 12 
6.4 
Methods of Statistical Analysis ................................................................................................. 12 
6.4.1 
Disposition ............................................................................................................................. 12 
6.4.2 
Demographic and Other Baseline Characteristics ................................................................ 12 
6.4.3 
Extent of Exposure and Treatment Compliance .................................................................... 12 
6.4.4 
Protocol Deviations ................................................................................................................ 13 
6.4.5 
Pharmacokinetic Analysis ...................................................................................................... 13 
6.4.6 
Pharmacodynamic Analysis................................................................................................... 13 
6.4.7 
Safety Analysis ...................................................................................................................... 14 
6.5 
Determination of Sample Size .................................................................................................. 16 
6.6 
Statistical Issues ....................................................................................................................... 16 
6.7 
Interim Analyses ....................................................................................................................... 16 
6.8 
Changes in the Conduct of the Study or Planned Analyses ..................................................... 16 
7 
REFERENCES .............................................................................................................................. 16 
8 
DATA PRESENTATION PLAN ..................................................................................................... 17 
8.1 
Tables for Section 14.1-3 .......................................................................................................... 17 
8.2 
Graphs for Section 14.2-3 ......................................................................................................... 18 
8.3 
Listings for Section 16.2 ........................................................................................................... 19 
APPENDICES ....................................................................................................................................... 20 
Appendix 1 Inclusion and Exclusion Criteria ......................................................................................... 20 
Appendix 2 Allowed and Disallowed Concomitant Medication ............................................................. 22 
 
 


Verona Pharma plc  
 
 
SAP: RPL554-010-2015 
 
Date: 03Jan2018   
Page 3 of 22 
Version: Final 2.0 
 
ABBREVIATIONS 
Abbreviation Term 
AE 
Adverse Event 
ANCOVA 
ATC 
Analysis of Covariance 
Anatomic Therapeutic Chemical 
ATS 
AUC 
American Thoracic Society 
Area Under the Curve 
BMI 
CAS 
Body Mass Index 
Completer Analysis Set 
CF 
Cystic Fibrosis 
CRF 
Case Report Form 
CS 
CV 
Clinically Significant 
Coefficient of Variation 
EBC 
Exhaled Breath Content 
ECG 
EDTA 
Electrocardiogram 
Ethylenediaminetetraacetic Acid 
eCRF 
Electronic Case Report Form 
FAS 
Full Analysis Set 
FEV1 
Forced Expiratory Volume in 1 Second 
FSH 
Follicle Stimulating Hormone 
FVC 
Forced Vital Capacity 
HIV 
Human Immunodeficiency Virus 
ICH 
International Conference on Harmonisation (of Technical 
Requirements for Registration of Pharmaceuticals for Human Use) 
ICS 
Inhaled Corticosteroid 
IL-8 
Interleukin 8 
LABA 
Long-Acting β2-Agonist 
LAMA 
Long-Acting Muscarinic Antagonist 
MedDRA 
MPO 
Medical Dictionary for Regulatory Activities 
Myeloperoxidase 
NCS 
PKS 
Not Clinically Significant 
PharmacoKinetic data Set 
PT 
Preferred Term 
QTcF 
SAE 
Heart-rate corrected QT interval (Fridericia’s method) 
Serious Adverse Event 
SAP 
SAS 
Statistical Analysis Plan 
Statistical Analysis Software 
SD 
Standard Deviation 
SOC 
System Organ Class 


Verona Pharma plc  
 
 
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Date: 03Jan2018   
Page 4 of 22 
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SOP 
SUSAR 
Standard Operating Procedure 
Suspected Unexpected Serious Adverse Reaction 
TEAE 
Treatment-Emergent Adverse Event 
TFL 
Tables, Figures and Listings 
TNF-α 
Tumour Necrosis Factor Alpha 
 
 
 
 


Verona Pharma plc  
 
 
SAP: RPL554-010-2015 
 
Date: 03Jan2018   
Page 5 of 22 
Version: Final 2.0 
 
1 INTRODUCTION 
This is the Statistical Analysis Plan (SAP) for study RPL554-010-2015.  It is based 
on the Clinical Study Protocol version 4.0 dated 23 August 2017.  
2 STUDY OBJECTIVES 
2.1 Primary Objective 
To investigate pharmacokinetics of single nebulised doses of RPL554 in patients 
with cystic fibrosis (CF). 
2.2 Secondary Objectives 
Secondary objectives are: 
 
• To investigate the bronchodilator effect on peak Forced Expiratory Volume in one 
second (FEV1) after single nebulised doses of RPL554 as compared to placebo 
 
• To investigate the bronchodilator effect on AUC FEV1 over 4, 6 and 8 hours of 
single nebulised doses of RPL554, as compared to placebo 
 
• To assess the tolerability and safety of single nebulised doses of RPL554  in 
patients with CF. 
2.3 Exploratory Objectives 
To examine the anti-inflammatory effects of RPL554 after a single dose in patients 
with CF. 
3 OVERALL STUDY DESIGN 
3.1 Overview of Study Design 
This is a Phase IIa, randomised, double blind, placebo controlled, complete block 
three way crossover study to investigate the pharmacokinetics of nebulised RPL554 
(1.5 mg and 6 mg) in adult patients with CF. It is planned to enrol sufficient patients 
to assure that 10 patients complete all three treatment periods at one centre in the 
UK. The study comprises five visits: screening (Visit 1), three treatment visits (Visit 2 
to Visit 4) and an end of study visit (Visit 5). Patients will be screened for eligibility 
(Visit 1), including a reversibility test with salbutamol, between 3 and 14 days prior to 
the first dose of study treatment. 
Eligible patients will then attend for three separate 1 day treatment visits (Visits 2 to 
Visit 4) each separated by a at least a 3-day washout period. Patients will be 
randomised pre-dose at Visit 2. Patients will receive a single nebulised dose of 1.5 
mg RPL554 or 6 mg RPL554 or placebo at each visit.  The pre-dose FEV1 at Visit 3 
and Visit 4 must be within ±20% of the pre-dose FEV1 at Visit 2 in order to ensure 
consistent baseline FEV1 for each study treatment. At each visit, patients will be 
resident at the study centre from the morning until at least 8 hours after dosing. 


Verona Pharma plc  
 
 
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Date: 03Jan2018   
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Version: Final 2.0 
 
Patients will be discharged after 8 hours, but return the following morning for final 
assessments 24 hours after dosing. 
The following will be performed at each treatment visit: 
• Measurements of lung function (FEV1 and forced vital capacity [FVC]) pre-dose 
and up to 24 hours post-dose 
• Blood sampling pre-dose and up to 24 hours post-dose for pharmacokinetic 
analysis 
• Sputum sampling pre-dose and at 8 and 24 hours post-dose for rheology and 
measurement of  inflammatory mediators (interleukin 8 [IL-8], tumour necrosis 
factor alpha [TNF-α], myeloperoxidase [MPO]) 
• Exhaled breath pH measurement pre-dose and at 8 and 24 hours post-dose  
• Urine pregnancy test pre-dose (female patients only) 
• Vital signs and 12-lead electrocardiogram (ECG)s pre-dose and up to 8 hours 
post-dose 
An end of study visit (Visit 5) will be performed 3 to 10 days after the last dose of 
study treatment. Adverse events will be recorded throughout the study and 
laboratory safety tests, a physical examination and urine pregnancy tests (female 
patients only) will be performed at screening (Visit 1) and at the end of study visit 
(Visit 5). 
Inclusion/exclusion criteria are given in Appendix 1. Allowed/disallowed medications 
are given in Appendix 2.  
3.2 Withdrawals 
Investigators have the authority to ask for the withdrawal of a patient at any time for 
medical or non-compliance reasons. Should the Investigator decide it is necessary to 
withdraw any patient for specific reasons, this should be recorded in writing and 
discussed with the patient in question. Such reasons for withdrawal are expected to 
be medical or related to lack of co-operation by the patient. 
If a patient withdraws following randomisation, every attempt should be made to 
contact the patient to determine the reason for withdrawal and to complete the 
recording of any available pharmacodynamic data and all adverse event data. If a 
patient agreed to enter the study and signed a consent form but withdrew from the 
study, or was withdrawn from the study, without receiving any study treatment, no 
further follow-up is necessary. 
End of study visits will occur 3 to 10 days after the last dose of study treatment. All 
withdrawn patients will follow this routine unless it is considered by the Investigator 
that they require greater medical supervision and/or investigations and in which case 
an unscheduled visit prior to and in addition to the scheduled follow up visit may be 
performed. 
If a patient decides to withdraw voluntarily, or is withdrawn by the Investigator 
responsible at any time, the reasons for withdrawal and results of all relevant tests 
will be recorded in the case report form (CRF). Patients who withdraw may be 
replaced. 


Verona Pharma plc  
 
 
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Date: 03Jan2018   
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Version: Final 2.0 
 
3.3 Replacements 
A total of 10 patients must complete all three treatment visits (Visit 2 to Visit 4) up to 
the 24 hour assessments in the study. Any patients who do not complete will be 
replaced. This should be discussed with the Sponsor on a case by case basis. 
Replacement patients will be allocated the next randomisation number in the 
randomisation list. 
4 STUDY MEASUREMENTS AND VARIABLES 
4.1 Endpoints 
4.1.1 
Primary Endpoint 
Plasma RPL554 pharmacokinetic parameters (AUC0−24, Cmax, tmax). 
4.1.2 
Secondary Endpoints 
Secondary endpoints are: 
• Peak and AUC FEV1 over 4, 6 and 8 hours 
• Determination of onset of action 
• Determination of duration of action 
• Safety and tolerability 
o Continuous monitoring of adverse events 
o Laboratory safety tests (haematology, biochemistry and urinalysis) 
o 12-lead ECG (including QTcF and heart rate), supine vital signs (blood 
pressure and pulse) over 8 hours 
4.1.3 
 Exploratory Endpoints 
Levels of inflammatory mediators in sputum and sputum rheology.  
4.2 Screening and Demographic Measurements 
Written informed consent will be obtained by the Investigator prior to any study 
related procedures being performed.  
Demographic variables, including date of birth, sex (plus details confirming 
non-childbearing status for females), height, weight, BMI (weight [kg]/height [m]2), 
race, ethnic origin and smoking status will be collected at screening (Visit 1). The 
date of diagnosis of CF and the specific CF mutations will also be recorded. 
Active medical conditions and all surgeries will be recorded at screening (Visit 1), 
including disease history which includes date of diagnosis.  
A reversibility test in response to salbutamol will be performed at screening (Visit 1). 
Spirometry (FEV1 and FVC) will be performed before and after (at 30 minutes and 1 
hour) two puffs of salbutamol administered using a pressurised metered dose 
inhaler. The pre-bronchodilator FEV1 must be ≥40% and ≤80% of predicted normal 
for inclusion. The reversibility response is not an eligibility measure. 


Verona Pharma plc  
 
 
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Date: 03Jan2018   
Page 8 of 22 
Version: Final 2.0 
 
At all three time points, three technically acceptable measurements should be made 
and recorded in the CRF. Spirometry assessments may be repeated up to eight 
times to obtain three acceptable readings according to American Thoracic Society 
[ATS] guidelines (Miller, 2005). The highest reading from each assessment will be 
used for calculation of predicted values and increase from baseline. European 
Community of Coal and Steel reference equations (Quanjer, 1993) will be used as a 
reference for predicted normal values.  
Laboratory safety assessments will be performed to check eligibility.  Unscheduled 
and/or repeat testing may be performed at the discretion of the Investigator. 
Prior respiratory therapies and medications will be recorded at screening (Visit 1) as 
well as concomitant use during the study. Other medications used prior or as 
concomitant use during the study will be recorded separately.  
Patients will be confirmed as eligible according to the inclusion and exclusion criteria 
from assessments made at screening (Visit 1) with a final check of all results 
pre-dose at Visit 2.  
4.3 Pharmacokinetic Measurements and Variables 
Pharmacokinetic analysis will be performed on samples taken from all patients. 
Blood samples (4 mL) will be collected at the following time points at Visit 2 to Visit 4: 
pre-dose, 15 and 30 minutes and 1, 2, 4, 6, 8 and 24 hours post-dose. Samples will 
be collected by venepuncture or via indwelling cannula in the forearm into lithium 
heparin tubes and will be immediately chilled (ice bath). The blood will be centrifuged 
within 15 minutes of collection. The plasma will be separated in a refrigerated 
centrifuge (about 4°C) at 1100 g for 15 minutes and transferred into polypropylene 
tubes. After each blood collection, the plasma will be dispensed into two aliquots. 
After appropriate labelling, the plasma samples will be stored at, or below -20°C. The 
plasma samples will then be transported in dry ice to the central laboratory where 
they will be stored at or below -20°C until they are analysed using a validated 
method. 
4.4 Pharmacodynamic Measurements and Variables 
4.4.1 
Spirometry 
Spirometry assessments (FEV1 and FVC) will be made at the following time points at 
Visit 2 to Visit 4: pre-dose (at -15 minutes) and 5, 15 and 30 minutes and 1, 2, 4, 6, 8 
and 24 hours post-dose in accordance with ATS guidelines (Miller, 2005). At all time 
points, three technically acceptable measurements should be made and recorded in 
the CRF. Spirometry assessments may be repeated up to eight times to obtain three 
acceptable readings. The highest FEV1 and FVC readings from each assessment 
will be used for analysis even if the FEV1 and FVC values come from two different 
forced exhalations. 
4.4.2 
Sputum Inflammatory Mediators 
Sputum samples will be taken pre-dose and at 8 and 24 hours post-dose at Visit 2 to 
Visit 4 by spontaneous expectoration over no more than 5 minutes and transported 
on ice for rapid processing (collection to storage within 30 minutes). Whole sputum 
will be immediately frozen at -20°C and then transferred to −80°C for storage prior to 
analysis (Horsley et al, 2014). 


Verona Pharma plc  
 
 
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Date: 03Jan2018   
Page 9 of 22 
Version: Final 2.0 
 
Rheological analysis will be performed before and after incubation at 37°C for 
60 minutes (Horsley et al, 2014). Inflammatory mediators (IL-8, TNF-α and MPO) will 
be measured according to the published methodology (Downey et al, 2007).  
4.4.3 
Exhaled Breath pH 
Exhaled breath pH will be measured pre-dose and at 8 and 24 hours post dose at 
Visit 2 to Visit 4. Exhaled breath pH measurement will be performed in accordance 
with the method described by MacNee et al, 2011. In brief, exhaled breath 
condensate (EBC) samples will be collected during tidal breathing for 10 minutes, 
without nose clips, using the RTubeTM (Respiratory Research Inc., Charlottesville, 
Virginia). A 200 µL aliquot of EBC will be used for the pH assay. Measurement of pH 
will be performed after deaeration by bubbling argon through the sample at 2 L/min 
while monitoring pH until the reading stabilised, usually after 8 minutes of deaeration 
with argon.  
4.5 Safety Measurements and Variables 
4.5.1 
Adverse Events 
Adverse event is defined as any undesirable experience occurring to a patient, or 
worsening in a patient, during a clinical study, whether or not considered related to 
the study treatment. An adverse event may be any of the following: 
• A new illness 
• An exacerbation of a sign or symptom of the underlying condition under treatment 
or of a concomitant illness 
• Unrelated to participation in the clinical study or an effect of the study drug 
• A combination of one or more of the above factors 
No causal relationship with the study treatment is implied by the use of the term 
“adverse event.” An exacerbation of a pre-existing condition or illness is defined as a 
more frequent occurrence or as an increase in the severity of the pre-existing 
condition or illness during the study. Planned or elective surgical or invasive 
procedures for pre-existing conditions that have not worsened are not adverse 
events. However, any complication that occurs during a planned or elective surgery 
is an adverse event (if the event fits the serious criteria, such as an extended 
hospitalisation, it will be considered to be serious). Conditions leading to unplanned 
surgical procedures may be adverse events. 
Adverse reaction is defined as all untoward and unintended responses to study 
treatment related to any dose administered. 
Serious adverse event (SAE) is any adverse experience that: 
• Results in death 
• Is life-threatening 
• Requires inpatient hospitalisation or prolongation of existing hospitalisation 
• Results in persistent or significant disability/incapacity, OR 
• Is a congenital anomaly/birth defect 
• Other medical events* 
*Important medical events that may not be immediately life-threatening or result in 
death or hospitalisation may be considered a SAE when, based on appropriate 


Verona Pharma plc  
 
 
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Date: 03Jan2018   
Page 10 of 22 
Version: Final 2.0 
 
medical judgement, they may jeopardise the patient or may require medical or 
surgical intervention to prevent one of the outcomes listed above. 
An unexpected adverse reaction is an adverse reaction in which the nature or 
severity of which is not consistent with the Investigator Brochure. 
Suspected unexpected serious adverse reactions (SUSAR) is any suspected 
adverse reaction related to the study drug that is both unexpected and serious. 
All adverse events, whether reported spontaneously by the patient, in response to 
open questioning on treatment days or observed by the investigator or his/her staff, 
will be recorded from informed consent until the end of study visit (Visit 5). The start 
and stop time will be recorded and adverse events will be assessed by the 
investigator for the following: 
• severity (mild, moderate, severe) 
• chronicity (single occasion, intermittent, persistent) 
• causality (not related, unlikely, possibly, definitely) 
• action taken with study treatment (none, study treatment stopped, study 
treatment temporarily interrupted) 
• other 
actions 
(none, 
concomitant 
medication, 
study 
discontinuation, 
hospitalisation, other) 
• outcome and date of outcome (recovered or resolved, recovering or resolving, 
not recovered or not resolved, recovered or resolved with sequelae, fatal, 
unknown) 
• seriousness (yes, no) 
4.5.2 
Laboratory Safety Measurements and Variables 
All female patients will have a urine pregnancy test at screening (Visit 1), pre-dose at 
Visit 2 to Visit 4 and at the end of study visit (Visit 5) according to the study centre’s 
standard operating procedures (SOPs). 
All other laboratory safety assessments will be performed at the study centre’s local 
laboratory. Two samples will be collected at each time point, one sample for 
haematology using a ethylenediaminetetraacetic acid (EDTA) whole blood collection 
tube and one sample for biochemistry using a serum tube. A midstream urine 
sample will also collected in a sterile container. Samples will be taken at screening 
(Visit 1) and end of study visit (Visit 5) and analysed for: 
Haematology: haemoglobin, haematocrit, total white cell count, leukocyte differential 
count and platelet count 
Biochemistry: 
creatinine, 
total 
bilirubin, 
alkaline 
phosphatase, 
aspartate 
aminotransferase, 
alanine 
transaminase, 
gamma-GT, 
lactate 
dehydrogenase, 
creatine 
kinase, 
thyroid 
stimulating 
hormone, 
triiodothyronine and thyroxine, glucose, potassium, sodium and calcium 
Urinalysis:  leukocytes, blood, ketones, bilirubin, urobilinogen, protein and glucose 
using a dipstick. In the event of an abnormal dipstick urinalysis result, 
microscopic urinalysis may be conducted. The referral criteria will be 
specified in the laboratory manual 
In addition, unscheduled and/or repeat testing may be performed at the discretion of 
the Investigator. Laboratory results will be provided to the Investigator for each 


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patient and each visit. The Investigator should assign whether each abnormal result 
is not clinically significant or clinically significant. 
4.5.3 
Vital Signs 
Blood pressure and pulse rate will be measured at screening (Visit 1) and pre-dose, 
30 minutes and 1, 2, 4, 6 and 8 hours post-dose at Visit 2 to Visit 4  
At each time point, supine vital signs will be assessed while the patient has been at 
rest for at least 5 minutes. 
4.5.4 
Physical Examination 
A full physical examination, covering major body systems (assessments of the nose, 
throat, skin, thyroid gland, neurological system, respiratory system, cardiovascular 
system, abdomen [liver and spleen], lymph nodes and extremities) will be performed 
at screening (Visit 1). Results will be recorded in the CRF as normal, abnormal not 
clinically significant or abnormal clinically significant. The physical examination will 
be repeated at the end of study visit (Visit 5), and any changes only recorded. 
4.5.5 
12-Lead ECG 
12-lead ECGs will be taken at screening (Visit 1) and pre-dose and 1, 2, 4 and 8 
hours post-dose at Visit 2 to Visit 4.  
At each time point, 12-lead ECGs should be taken after at least 5 minutes in the 
supine position. An ECG printout must be taken at each time point and signed and 
dated by the Investigator. An overall assessment (normal, abnormal not clinically 
significant or abnormal clinically significant) and continuous variables, including QT 
interval, QTcF and heart rate, will be recorded in the CRF. 
5 DATA MANAGEMENT 
Data management will be performed by Syne-qua-non. Data handling will be 
described in a Data Management Plan and a Data Validation Plan. 
6 STATISTICAL METHODS AND DETERMINATION OF SAMPLE 
SIZE 
6.1 Statistical Evaluation 
The statistical analysis will be conducted by StatMind AB using SAS version 9.3 or 
higher. Validation will be performed using Gauss 6.25. 
The statistical analyses and reporting of results (tables, figures and listings [TFL]) for 
this study follows the International Conference on Harmonisation (ICH) guidelines. 
6.2 Description of Analysis Sets 
Allocation of patients to the analysis populations (and whether any patients or 
specific data from a patient will be excluded) will be determined at the pre-database 
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The full analysis set [FAS] will consist of all randomised patients with sufficient data 
collected after intake of study treatment to compute the pharmacodynamic 
parameters on at least two study visits. 
The completer analysis set [CAS] will consist of all randomised patients with 
sufficient data collected after intake of study treatment to compute the 
pharmacodynamic parameters on all three study visits. 
The safety set will consist of all randomised patients with safety data collected after 
intake of study treatment during at least one visit.  
The pharmacokinetic data set [PKS] will consist of all randomised patients with blood 
sampling performed after at least one dose of RPL554 and with data sufficient to 
calculate pharmacokinetic parameters. 
6.3 Summary Statistics 
Continuous variables will be summarised using descriptive statistics (number of 
patients [N], arithmetic mean, standard deviation [SD], median, minimum and 
maximum values) and for categorical (nominal) variables, the number and 
percentage of patients will be used. For continuous variables with an expected skew 
distribution (plasma RPL554 concentrations, some pharmacokinetic parameters 
[AUC0−24, Cmax], inflammatory cell mediators [IL-8, TNF-α, MPO]), geometric mean 
and coefficient of variation (CV) will be given instead of arithmetic mean and SD.  
6.4 Methods of Statistical Analysis 
6.4.1 
Disposition 
A summary of the patient flow (number and percentage) will be made of all patients 
enrolled in the study, randomized in the study, belonging to each of the analysis 
sets, completed the study or prematurely discontinued the investigational product. 
The primary reason for withdrawal from the study will be summarized into the 
following categories: consent withdrawn, adverse event, protocol violation, 
investigator’s decision, sponsor decision or other reason. Patient disposition data 
including individual reasons for withdrawal will be listed. 
6.4.2 
Demographic and Other Baseline Characteristics 
Demographics and baseline characteristics including age, sex, race, ethnic origin, 
height, weight, BMI, smoking status, pack years, time since CF diagnosis, CF 
mutations, FEV1 [both in litres and in percentage of predicted normal], FVC and 
FEV1 reversibility will be listed and summarised by descriptive statistics. 
Prior and concomitant CF therapies will be listed and summarised by ATC class for 
all enrolled patients (long-acting and short-acting LABAs and LAMAs will be 
separated).  
Other medical history and other prior and concomitant medications will be listed. 
Medical history events will be coded using the MedDRA Dictionary in addition to the 
verbatim. 
6.4.3 
Extent of Exposure and Treatment Compliance 
All administration of study treatment will be done at the clinic under supervision of 
the study staff; therefore no formal analysis of compliance will be performed. The 


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RPL554 exposure will be calculated based on residual volume in the nebuliser cup 
and summarised by treatment group. The exposure would equal (nominal volume – 
residual volume) times the drug concentration. 
6.4.4 
Protocol Deviations 
Protocol deviations will be categorized as eligibility deviation, sample handling error, 
missed assessment, late or early assessment, outside visit window or other 
category. All protocol deviations collected will be divided into major or minor 
categories. Prior to database lock protocol deviations will be reviewed and 
consequences for inclusion of patients in various analysis population sets 
determined and documented. All details of protocol deviations in the study will be 
listed. Further protocol deviation will be summarised by category and minor/major 
assessment. 
6.4.5 
Pharmacokinetic Analysis 
Blood sampling for pharmacokinetic assessments will be done pre-dose and up to 24 
hours post-dose. From the plasma concentrations of RPL554 collected, the following 
pharmacokinetic parameters will be calculated using standard non-parametric 
methods. 
• AUC0−24 is the area under the plasma concentration curve from time 0 to 24 
hours post-dose, computed using the linear trapezoidal method 
• Cmax denotes the highest plasma concentration measured 
• tmax denotes the time point corresponding to Cmax 
Pharmacokinetic parameters will be summarised by dose level using descriptive 
statistics. Graphics will include individual and mean plasma concentration – time 
curves (both on linear and semi-log scale) and scatter plots of computed 
pharmacokinetic parameters with mean levels indicated. 
6.4.6 
Pharmacodynamic Analysis 
6.4.6.1 Spirometry 
For FEV1 the average effect, (Eav), will be calculated as the Area Under the Curve 
(AUC) divided by the length of the time interval of interest. The AUC will be 
computed using the linear trapezoidal rule. Linear interpolation/extrapolation will be 
used to fill in a missing value (at most one missing value allowed) at end of the 
computational interval prior to calculation. In addition, the peak effect on FEV1 will be 
computed as the maximum value (Emax) within 4 hours post-dosing. In analysis, Eav 
and Emax will be normalized using the baseline value.  
Computed pharmacodynamic parameters for FEV1 will be compared between 
placebo and the two doses of RPL554 using analysis of covariance (ANCOVA) 
models with fixed factors for treatment, period and patient, and using the baseline of 
the day as a covariate. FEV1 will be analysed using multiplicative models, which 
means that data is logged prior to analysis and the result then transformed back to 
the linear scale giving treatment differences as ratios of geometric means. All three 
pairwise comparisons will be stated and expressed as the geometric mean ratio with 
95% confidence interval and associated, 2-sided, p-value. 
All spirometry data will be listed and summarized by treatment and assessment point 
as well as the change from baseline. Pharmacodynamic parameters will be 


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summarized by treatment. Graphics will include individual and mean FEV1 and FVC 
curves over time (expressed as change from baseline on absolute scale) and scatter 
plots of computed pharmacodynamic parameters with the mean levels indicated. 
Onset of effect will be defined as time to reach a 10% increase in FEV1 counted from 
start/end of nebulization. Patients not reaching a response after 2 hours will be 
censored. Outcome will be illustrated using a Kaplan-Meier plot and, if appropriate, 
the median time to onset by (active) treatment group determined. 
Duration of effect will be assessed by consecutively testing effect of active treatment 
versus placebo for increasing time points using similar models as the analysis of the 
pharmacodynamics parameters. If missing values exist, these will be filled in using 
linear interpolation/extrapolation prior to analysis. 
6.4.6.2 Sputum inflammatory mediators, rheology and exhaled breath pH 
Il-8, TNF-α, MPO, exhaled breath pH and sputum viscoelasticity (log G) collected 6 
and 24 h after dose administration will be compared between treatments using 
similar ANCOVA models as for the FEV1 parameters. Multiplicative models will be 
used for the sputum inflammatory mediators, additive (linear) models for exhaled 
breath pH and sputum viscoelasticity (log G) that already are expressed on log 
scales.  
All data will be listed and summarized by treatment and assessment point as well as 
the change from baseline. Graphics will include individual and mean value curves 
over time for each variable. 
6.4.7 
Safety Analysis 
6.4.7.1 Adverse Events 
Adverse events (AEs) will be collected throughout the study and will be coded 
according to the current version of the MedDRA dictionary. A treatment-emergent 
adverse event (TEAE) is defined as an AE that started or worsened after intake of 
study treatment in each treatment period. If the start date is unknown then the AE 
will be assumed to be treatment emergent unless the partial start date, or other data 
(i.e. stop date) indicates differently. The TEAEs will be assigned to the treatment 
given prior to onset of the event. In summaries, causally related AEs will consist of 
AEs classified as Unlikely, Probably or Definitely related to study treatment. 
Coded adverse event terms will be presented by system organ class (SOC) and 
preferred term and summarised by treatment group. A summary table by treatment 
group with total number and number of patients with adverse events, SAEs, adverse 
events leading to discontinuation of study treatment, causally related adverse events 
and severe adverse events will be produced. Further SAEs, causally related adverse 
events and adverse events of each intensity will be summarised by SOC and 
preferred term. 
AEs will be presented in decreasing frequency of the total number of patients with 
TEAEs. All AEs, including those which are not treatment emergent, will be listed. If 
appropriate, SAEs and AEs leading to discontinuation of study treatment will also be 
separately listed. 
6.4.7.2 Laboratory tests 
Safety laboratory test data will be summarised by treatment group and time point. 
For continuous variables, the change from baseline (pre-dose at each treatment 


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visit) to each post-dose time point will also be calculated and summarised. Data will 
further be illustrated by shift tables (showing changes from low/normal/high) and shift 
plots for change over the study. 
The baseline value will be defined as the last scheduled, unscheduled or repeat 
value collected prior to first dosing. The tabulation will only include scheduled visits; 
all unscheduled assessments will be displayed in the listing as appropriate.  
All laboratory values will be listed showing reference ranges and flagging all 
abnormal findings and their clinical significance (CS or NCS). Out of reference range 
values will be flagged as high (H) or low (L). A similar listing including all post-dose 
laboratory values found abnormal, including the baseline result and clinical 
significance, will also be produced.  
6.4.7.3 Vital Signs 
Vital signs data will be summarised by treatment group and time point. The change 
from baseline (pre-dose at each treatment visit) to each post-dose time point will also 
be calculated and summarised. Data will further be illustrated by shift tables 
(showing changes from low/normal/high) and shift plots for the change from baseline 
to worst case during the treatment period.  
The baseline value will be defined as the last scheduled, unscheduled or repeat 
value collected prior to dosing in a period. The tabulation will only include scheduled 
visits; all unscheduled assessments will be displayed in the listing as appropriate.  
Vital signs will be listed showing reference ranges and flagging all abnormal findings 
and their clinical significance (CS or NCS). Out of reference range values will be 
flagged as high (H) or low (L). A similar listing including all post-dose vital signs 
values found abnormal, including the baseline result and clinical significance, will 
also be produced.  
Further, for data collected during treatment days, graphics will include individual and 
mean value curves over time for each variable expressed as change from baseline. 
6.4.7.4 12-Lead ECG 
12-lead ECG data will be summarised and illustrated in the same way as vital signs 
data. In addition, for QTcF, a plot showing the baseline value of the treatment day on 
the x-axis versus the post-dose value indicating the largest absolute change on the 
y-axis will be constructed. QTcF data will also be summarised according to 
frequencies of values >450 ms, >480 ms and >500 ms and according to frequencies 
of shifts from baseline of the treatment day to post-dose of >30 ms and >60 ms. 
6.4.7.5 Physical Examination 
Physical examination data (changes in status between Visit 1 and Visit 5) will be 
listed.  
6.4.7.6 Rescue Medication 
Rescue medication used during the treatment visits will be summarised by treatment 
group and all individual use listed. 
6.4.7.7 Concomitant Medications 
Prior medications are defined as those with a stop date prior to the date of the first 
dose of study treatment. Concomitant medications are defined as those medications 
with either a start date or a stop date that is after the date of first dose of study 


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treatment. If the start date is unknown then it will be assumed to be concomitant 
unless the partial start date, or other data (i.e. stop date) indicates differently. 
All prior and concomitant medications will be listed by reported name, medication 
class, standardised medication name, indication. dose, dose unit, route of 
administration, dosing frequency, start and end dates.  
6.4.7.8 Pregnancy tests 
Pregnancy test results, or reasons for not performing the test(s), from females at 
screening, pre-dose at each treatment visit and at end-of-study will be listed. 
6.5 Determination of Sample Size 
This is a sample size of convenience. No calculation of power was performed. 
6.6 Statistical Issues 
All hypothesis testing will be done using two-sided alternative hypotheses. P-values 
less than 5% will be considered statistically significant. 
No adjustment for multiple testing will be done. A closed testing procedure will be 
applied: first the higher dose of RPL544 will be tested versus placebo and then, if 
statistically significant, the lower dose of RPL554 versus placebo. Finally the two 
doses of RPL554 will be compared. 
Patients withdrawn after only one treatment period will not be included in the efficacy 
analyses. No imputation of missing data other than described under Section 6.4 will 
be performed. 
Sensitivity analyses of pharmacodynamic data will be done to explore the impact of 
outliers or, for FEV1 parameters, the use of rescue medication during the clinic visits. 
All available data from all patients who have received study treatment will be listed 
and summarised. Any unscheduled or unplanned readings will be presented within 
the patient listings, but only the scheduled readings will be used in any summaries. If 
a visit is rescheduled due to variability in FEV1 or other reason, the rescheduled visit 
will be listed and summarised as the valid visit. 
6.7 Interim Analyses 
No formal interim analysis is planned for the study. 
6.8 Changes in the Conduct of the Study or Planned Analyses 
Clinical Study Protocol version 2.2 stated that the pharmacokinetic parameters 
should include AUC0-∞, Cmax, Tmax and the terminal half-life, t1/2. Due to the sampling 
scheme was considered insufficient to capture an appropriate t1/2 estimate, this 
parameter was omitted and AUC0-∞ was replaced with an AUC0-24 (area under the 
scheduled sampling period). 
7 REFERENCES 
Miller MR, Hankinson J, Brusasco V et al. Standardisation of spirometry. Eur Respir 
J 2005;26(2):319-338 


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Quanjer PH, Tammeling GJ, Cotes JE et al. Lung volumes and forced ventilatory 
flows. Report Working Party Standardization of Lung Function Tests, European 
Community for Steel and Coal. Official Statement of the European Respiratory 
Society. Eur Respir J Suppl. 1993 Mar; 16:5-40 
8 DATA PRESENTATION PLAN 
8.1 Tables for Section 14.1-3 
Safety set used for tables if not otherwise indicated  
o 14.1.1.1 Patient disposition 
o 14.1.1.2 Patient flow 
o 14.1.2.1 Summary of protocol deviations  
o 14.1.3.1 Summary of demographic data and baseline characteristics 
o 14.1.3.2 Summary of prior cystic fibrosis medications  
o 14.1.3.3 Summary of life-style restrictions and nebuliser training  
o 14.1.3.4 Summary of drug exposure data from nebulisations   
o 14.2.1.1 Summary of plasma RPL554 concentrations [PKS] 
o 14.2.1.2 Summary of pharmacokinetic parameters based on plasma RPL554 
concentrations [PKS] 
o 14.2.2.1 Summary of spirometry (FEV1 and FVC) at clinic visits [FAS and 
CAS] 
o 14.2.2.2 Summary of pharmacodynamic parameters based on FEV1 [FAS and 
CAS] 
o 14.2.2.3 Statistical analysis of pharmacodynamic parameters based on FEV1 
(multiplicative models) [FAS and CAS] 
o 14.2.2.4 Statistical analysis of FEV1 by assessment point (duration of action, 
multiplicative models) [FAS] 
o 14.2.3.1 Summary of inflammatory mediators, sputum rheology and exhaled 
breath pH at clinic visits [FAS] 
o 14.2.3.2 Statistical analysis of inflammatory mediators (multiplicative models) 
[FAS] 
o 14.2.3.3 Statistical analysis of sputum rheology and exhaled breath pH 
(additive models) [FAS] 
o 14.3.1.1 Summary of treatment emergent adverse events  
o 14.3.1.2 Summary of adverse events by system organ class and preferred 
term  
o 14.3.1.3 Summary of adverse events causally related to treatment by system 
organ class and preferred term  
o 14.3.1.4 Summary of adverse events of moderate or severe intensity by 
system organ class and preferred term  


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o 14.3.1.5 Summary of adverse events with chronicity intermittent or persistent 
by system organ class and preferred term  
o 14.3.2.1 Summary of serious adverse events by system organ class and 
preferred term  
o 14.3.4.1 Summary of  laboratory tests (continuous variables) at clinic visits  
o 14.3.4.2 Summary of laboratory tests (categorical variables) at clinic visits  
o 14.3.4.3 Summary of abnormal findings on laboratory data  
o 14.3.5.1 Summary of vital signs at clinic visits  
o 14.3.5.2 Summary of abnormal findings on vital signs  
o 14.3.5.3 Summary of 12-lead ECG data at clinic visits  
o 14.3.5.4 Summary of abnormal findings on 12-lead ECG  
o 14.3.5.5 Summary of abnormal findings on physical examination  
o 14.3.5.6 Summary rescue medication use during clinic visits  
o 14.3.5.7 Summary of pregnancy tests  
8.2 Graphs for Section 14.2-3 
Safety set used for graphics if not otherwise indicated 
o 14.2.1.1 Individual plasma concentration-time curves for RPL554 [PKS] 
o 14.2.1.2 Mean plasma concentration-time curves for RPL554 [PKS] 
o 14.2.1.3 Scatter plots of computed pharmacokinetic parameters [PKS] 
o 14.2.2.1 Individual curves for FEV1 on absolute scale [FAS] 
o 14.2.2.2 Individual curves for FEV1 as change from baseline [FAS] 
o 14.2.2.3 Mean value curves for FEV1 on absolute scale [FAS and CAS] 
o 14.2.2.4 Mean value curves for FEV1 as change from baseline [FAS and CAS] 
o 14.2.2.5 Scatter plots of pharmacodynamic parameters based on FEV1 [FAS] 
o 14.2.2.6 Individual curves for FVC, absolute and as change from baseline 
[FAS] 
o 14.2.2.7 Mean value curves for FVC, absolute and as change from baseline 
[FAS]  
o 14.2.3.1 Individual curves for inflammatory mediators, exhaled breath pH and 
sputum rheology by treatment [FAS] 
o 14.2.3.2 Mean value curves for inflammatory mediators, exhaled breath pH 
and sputum rheology, absolute and change from baseline [FAS] 
o 14.3.4.1 Shift plots for laboratory data 
o 14.3.5.1 Individual curves for vital signs, absolute and change from baseline 
o 14.3.5.2 Mean value curves for vital signs, absolute and change from baseline 
o 14.3.5.3 Individual curves for 12-lead ECG, absolute and change from 
baseline 


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o 14.3.5.4 Mean value curves for 12-lead ECG, absolute and change from 
baseline 
o 14.3.5.5 Scatter plot of baseline QTcF versus post-dose assessment 
indicating largest absolute change from baseline 
8.3 Listings for Section 16.2 
Safety set used for listings if not otherwise indicated 
o 16.2.1.1 Randomised patients that completed the study 
o 16.2.1.2 Randomised patients that were withdrawn the study 
o 16.2.1.3 Visit dates by patient 
o 16.2.1.4 Eligibility by patient 
o 16.2.2.1 Listing of protocol deviations 
o 16.2.3.1 Analysis dataset allocation by patient 
o 16.2.4.1 Demographic data and baseline characteristics 
o 16.2.4.2 Lung function at baseline and diagnosis of cystic fibrosis 
o 16.2.4.3 Listing of medical history 
o 16.2.5.1 Listing of drug exposure 
o 16.2.5.2 Life-style restrictions to adhere to prior to visits and nebuliser training 
o 16.2.5.3 Plasma concentrations of RPL554 [PKS] 
o 16.2.5.4 Pharmacokinetic parameters [PKS] 
o 16.2.6.1 Listing of spirometry data [FAS] 
o 16.2.6.2 Derived pharmacodynamic parameters based on FEV1 [FAS] 
o 16.2.6.3 Listing of inflammatory mediators, sputum rheology and exhaled 
breath pH [FAS] 
o 16.2.7.1 Listing of adverse events 
o 16.2.7.2 Listing of serious adverse events 
o 16.2.7.3 Listing of adverse events leading to discontinuation of study 
treatment 
o 16.2.8.1 Listing of laboratory data 
o 16.2.9.1 Listing of vital signs 
o 16.2.9.2 Listing of 12-lead ECG 
o 16.2.9.3 Listing of physical examination 
o 16.2.9.4 Concomitant medications at entry and during the study 
o 16.2.9.5 Rescue medication used during clinic visits 
o 16.2.9.6 Listing of pregnancy tests (female patients) 
 
 


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APPENDICES 
Appendix 1 Inclusion and Exclusion Criteria 
Inclusion Criteria: 
 
1. 
Sign an informed consent document indicating they understand the purpose of 
and procedures required for the study and are willing to participate in the study. 
2. 
Male or female aged ≥18 years at the time of informed consent. Females of 
childbearing potential must have been using a consistent and reliable form of 
contraception from the last menses before the first study treatment 
administration, and must commit to continue to do so during the study and for 3 
months after the last dose of study treatment. 
3. 
Have a 12-lead electrocardiogram (ECG) recording at screening (Visit 1) and 
Visit 2 pre-dose showing the following: 
• 
Heart rate between 45 and 90 beats per minute 
• 
QT interval corrected for heart rate using Fridericia’s formula (QTcF) 
interval ≤450 msec  
• 
QRS interval ≤120 msec 
• 
PR interval ≤220 msec 
• 
No clinically significant abnormality including morphology (e.g. left bundle 
branch 
block, 
atrioventricular 
nodal 
dysfunction, 
ST 
segment 
abnormalities) 
4. 
Capable of complying with all study restrictions and procedures including ability 
to use the study nebuliser correctly. 
5. 
Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) with a minimum 
weight of 40 kg. 
6. 
Patients with a genetic diagnosis of CF  
7. 
Spirometry at screening demonstrating an FEV1 ≥40% and ≤80% of predicted 
normal. 
8. 
Capable of withdrawing from long acting bronchodilators for 48 hours prior to 
study visits, and short acting bronchodilators for 8 hours prior to study visits. 
9. 
Clinically stable CF in the 2 weeks prior to randomisation (Visit 2). 
Exclusion Criteria: 
 
1. 
History of cirrhotic liver disease or portal hypertension. 
2. 
CF exacerbation requiring hospitalization in the month prior to screening 
(Visit 1) or prior to randomisation (Visit 2). 
3. 
Use of oral or intravenous antibiotics (in additional to usual maintenance 
therapy) in the 2 weeks prior to screening (Visit 1) or randomisation (Visit 2). 


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4. 
Other non-CF related respiratory disorders: Patients with a current diagnosis of 
asthma, active tuberculosis, lung cancer, sarcoidosis, sleep apnoea, known 
alpha-1 antitrypsin deficiency or other active pulmonary diseases. 
5. 
Previous lung resection or lung transplant. 
6. 
History of, or reason to believe a patient has, drug or alcohol abuse within the 
past 3 years. 
7. 
Received an experimental drug within 3 months or five half-lives, whichever is 
longer.  
8. 
Patients with a history of chronic uncontrolled disease including, but not limited 
to, cardiovascular (including arrhythmias), endocrine, active hyperthyroidism, 
neurological, hepatic, gastrointestinal, renal, haematological, urological, 
immunological, or ophthalmic diseases that the Investigator believes are 
clinically significant. 
9. 
Documented cardiovascular disease: angina, recent or suspected myocardial 
infarction, congestive heart failure, a history of unstable, or uncontrolled 
hypertension, or has been diagnosed with hypertension in last 3 months. 
10. 
Has had major surgery, (requiring general anaesthesia) in the 6 weeks prior to 
screening (Visit 1), or will not have fully recovered from surgery, or planned 
surgery through the end of the study. 
11. 
Infection 
with 
nontuberculous 
mycobacteria, 
methicillin-resistant 
Staphylococcus aureus (MRSA), B. Cepecia, or B. cenocepecia. 
12. 
Use of immune-suppression; long term use of prednisolone >10 mg/day 
13. 
History of malignancy of any organ system within 5 years with the exception of 
localised skin cancers (basal or squamous cell) 
14. 
Clinically significant abnormal values for safety laboratory tests (haematology, 
biochemistry or urinalysis) at screening, as determined by the Investigator. 
15. 
A disclosed history or one known to the Investigator, of significant 
non-compliance in previous investigational studies or with prescribed 
medications. 
16. 
Requires oxygen therapy on a regular basis. 
17. 
Pregnancy or lactation (female patients only) 
18. 
Any other reason that the Investigator considers makes the patient unsuitable 
to participate. 
 


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Appendix 2 Allowed and Disallowed Concomitant Medication 
Patients taking inhaled steroids may continue their medication only if the dose is 
stable from at least four weeks prior to screening and is expected to remain stable. 
All long acting (once or twice daily) bronchodilators will be stopped at the screening 
visit and are not allowed during the study. Patients should not use a long acting 
bronchodilator 
(long 
acting 
muscarinic 
antagonists 
[LAMA], 
long 
acting 
beta2-agonists [LABA], or combination LABA/inhaled steroid) on the day of 
screening.  
• Patients taking LAMAs and LABAs should be placed on short acting 
bronchodilators (e.g. salbutamol, ipratropium or Combivent) as per the discretion 
of the Investigator. These can be dosed on a regular scheduled basis and/or as 
needed use 
• Patients taking combination products should be prescribed the inhaled steroid at 
the same or equivalent dose contained in the combination product to allow 
continuation of steroid use regularly throughout the study while stopping the 
LABA component  
Patients currently taking terbutaline will be switched to other short acting 
bronchodilators (e.g. salbutamol). 
Short acting bronchodilators must be withheld for at least 8 hours prior to spirometry 
at each study visit (Visit 1 to Visit 4). If this withhold is not met, the patent should be 
rescheduled for a repeat visit within 7 days.  
Patients may continue other prescribed non-respiratory therapies during the study 
that the Investigator considers to neither compromise patient safety nor affect study 
data. Pulmonary rehabilitation programs should not be started or completed during 
this period. Oxygen therapy is an exclusion criterion for this study.