Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: ResMed

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Protocol 
 
 
POC-LEAN 
 
 
 
 
Evaluation of a Portable Oxygen Concentrator during Ambulation 
for Patients Who Require Supplemental Oxygen  
 
 
 
 
 
 
 

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This protocol has been written in accordance with current applicable guidelines as well as all other relevant additional 
references, medical and legal. The information herein is confidential and the property of ResMed. It is to be used in 
confidence for the conduct of the clinical study according to written agreement.

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ABBREVIATIONS AND DEFINITIONS 
Abbreviation  
Definition  
6MWT 
Six Minute Walk Test 
6MWD 
Six Minute Walk Distance 
AE 
AO 
ATS  
Adverse event 
Ambulatory oxygen 
American Thoracic Society 
COPD 
Chronic obstructive pulmonary disease 
EC 
Ethics committee 
EDC 
Electronic data capture 
ERS 
European Respiratory Society 
FDA 
U.S. Food and Drug Administration 
FiO2 
Fraction of inspired oxygen 
GCP 
Good Clinical Practice 
GP 
General practitioner 
ICH 
International Conference on Harmonisation 
IEC 
Independent ethics committee 
IRB 
Institutional Review Board 
LTOT 
Long-term oxygen therapy  
LO 
Liquid oxygen  
mBORG 
Modified BORG Scale 
OC 
Oxygen concentrators 
POC 
Portable oxygen concentrator 
PPG 
Photoplethysmography 
SAE 
Serious adverse event 
SpO2 
Oxygen saturation 
TMF 
Trial Master File 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS  
 
1. 
SUMMARY 
6 
2. 
INTRODUCTION 
7 
2.1 
Background 
8 
2.1.1 
Chronic Obstructive Pulmonary Disease 
8 
2.1.2 
Long-term oxygen therapy 
8 
2.2 
Rationale for the Study 
9 
3. 
DESCRIPTION OF THE MEDICAL DEVICES 
9 
3.1 
Portable Oxygen Concentrator (POC) 
9 
3.1.1 
Reprocessing the device 
9 
3.2 
Portable Oxygen Cylinder 
9 
3.3 
Other Medical Devices 
9 
3.3.1 
SpO2 Monitoring 
9 
4. 
OBJECTIVES AND ENDPOINTS 
9 
4.1 
Objectives 
9 
4.1.1 
Primary objective 
9 
4.1.2 
Secondary objective 
10 
4.2 
Endpoint 
10 
4.2.1 
Primary endpoint 
10 
4.2.2 
Secondary endpoints 
10 
5. 
STUDY DESIGN 
10 
5.1 
Study Design 
10 
5.2 
Study Site(s) 
10 
5.3 
Participant recruitment 
10 
6. 
STUDY POPULATION 
11 
6.1 
Number of Study Participants 
11 
6.2 
Inclusion Criteria 
11 
6.3 Exclusion Criteria 
11 
7. 
STUDY PROCEDURES 
11 
7.1 
Screening Visit 
11 
7.1.1 
Demography 
11 
7.1.2 
Body weight and height 
12 
7.1.3 
COPD history and comorbidities 
12 
7.1.4 
Medical history 
12 
7.1.5 
Concomitant medication 
12 
7.2 
Visit 1 
13 
7.2.1 
Prior to 6MWT 
13 
7.2.2 
During 6MWT 
14 
7.2.3 
Post 6MWT 
14 
7.3 
End of Study 
14 
8. 
ADVERSE EVENTS 
15 
8.1 
Definitions 
15 
8.1.1 
Adverse Event 
15 
8.1.2 
Serious Adverse Event 
16 
8.1.3 
Anticipated Adverse Events 
16 
8.2 
Adverse Event Assessment and Reporting 
17 
8.2.1 
Adverse Event Assessment 
17 
8.2.2 
Adverse Event Reporting 
17 
8.2.3 
For US only: Mandatory Medical Device Reporting 
17 
8.2.4 
Device Deficiency 
17 

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9. 
RISK AND BENEFITS 
17 
9.1 
Potential Risks 
17 
9.1.1 
Minimization of Risks 
17 
9.2 
Potential benefits 
18 
10. 
STATISTICAL CONSIDERATIONS 
19 
10.1 
Primary Objective and Endpoint 
19 
10.2 
Analysis Populations 
19 
10.3 
Statistical Analysis of the Primary Endpoint 
19 
10.4 
Justification of Sample Size 
19 
10.5 
General Statistical Analysis Guidelines 
20 
10.6 
Baseline Characteristics and Medical History 
20 
10.7 
Statistical Analysis of Secondary Endpoints 
20 
10.8 
Safety Analyses 
20 
10.9 
Handling of Missing Values 
20 
11. 
RESPONSIBILITY 
21 
11.1 
Investigator Responsibilities 
21 
11.1.1 
Statement of Compliance 
21 
11.1.2 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Ethics Committee (EC) 
Review and Approval 
21 
11.1.3 
Informed Consent Process 
21 
11.1.4 
Confidentiality 
21 
11.1.5 
Study Files and Retention of Records 
Error! Bookmark not defined. 
11.1.6 
Electronic Case Report Forms 
Error! Bookmark not defined. 
11.1.7 
Protocol Deviations 
Error! Bookmark not defined. 
11.1.8 
Device Accountability 
Error! Bookmark not defined. 
11.2 
Sponsor Responsibilities 
Error! Bookmark not defined. 
11.2.1 
Protocol Modifications 
Error! Bookmark not defined. 
11.2.2 
Data Safety Monitoring Board 
Error! Bookmark not defined. 
11.2.3 
Data management 
Error! Bookmark not defined. 
11.2.4 
Report and Publication 
Error! Bookmark not defined. 
11.3 
Joint Investigator/Sponsor Responsibilities 
Error! Bookmark not defined. 
11.3.1 
Access to Information for Monitoring 
Error! Bookmark not defined. 
11.3.2 
Access to Information for Auditing or Inspections 
Error! Bookmark not defined. 
11.3.3 
Early Study Termination 
Error! Bookmark not defined. 
12. 
REFERENCES 
22 
APPENDIX 1 
ERROR! BOOKMARK NOT DEFINED. 
APPENDIX 2 
ERROR! BOOKMARK NOT DEFINED. 
APPENDIX 3 
ERROR! BOOKMARK NOT DEFINED. 
APPENDIX 4 
ERROR! BOOKMARK NOT DEFINED. 
 
 
 

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1. Summary  
Design:  
Prospective randomized study with a cross-over design. 
Device:  
All participants entered into the study will be randomized to complete a 
6MWT with either of the following devices, in a cross-over fashion and 
with a one-hour wash-out period between tests: 
 Control device (portable oxygen cylinder) first; or  
 Study device (Mobi™, POC) first.  
 
Objectives:  
The primary objective of this study is to compare mean oxygen 
saturations (SpO2) between using the Mobi TM and an oxygen cylinder 
during the Six Minute Walk Tests (6MWTs). 
 
The secondary objective of this study is to evaluate the participant 
experience when using Mobi™ and an oxygen cylinder whilst walking, 
based on levels of dyspnea and distance covered during the 6MWTs. 
 
Primary Endpoint:  
Mean SpO2 during Six Minute Walk Tests (6MWTs) for use of Mobi™ 
compared use of oxygen cylinder. 
 
Secondary 
Endpoints:  
 Distance covered during the 6MWTs 
 Post-6MWT SpO2 
 Time spent ≥ 90% SpO2 during 6MWT 
 Participant acceptance questionnaire around ease of use and other 
aspects specific to portable oxygen use 
 Dyspnea and fatigue levels measured by Modified Borg scale 
(mBorg) 
 
Enrollment:  
Up to 32  participants who meet the inclusion and exclusion criteria are 
anticipated to be randomized for this study 
Study Site(s)  
 
1 site in the United States 

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Selection Criteria:  
Inclusion Criteria 
Participants must meet all of the following inclusion criteria to be eligible 
for participation in this study: 
 
1. Informed consent obtained before any study-related activities. Study-
related activities are any procedures that are carried out as part of the 
study, including activities to determine suitability for the study.  
2. Male or female, age ≥ 18 years at the time of signing informed 
consent.  
3. Diagnosed with COPD and currently in a stable state (at least 4 weeks 
since last exacerbation episode22). 
4. Current prescription for long-term oxygen therapy. 
5. Participant meets the criteria for pulse-dose portable oxygen delivery, 
defined as being mobile within the home and the qualifying blood gas 
study was performed at rest/ awake or during exercise.    
6. Participant can read and comprehend English. 
 
Exclusion Criteria 
Participants who meet any of the following exclusion criteria are not to 
be enrolled in this study: 
 
1. Clinically unstable, which in the investigator’s opinion, may 
jeopardize the participant’s safety or compliance with the protocol. 
2. Current oxygen therapy prescription which requires >5 L/min 
continuous flow. 
3. Known or suspected contraindication for pulse-dose (e.g. using 
oxygen for life-sustaining or life-supporting purpose. 
4. Unable to complete 6MWTs, e.g., unstable angina and myocardial 
infarction during the previous month.  
5. Female who is pregnant, breast-feeding, or intends to become 
pregnant, or is of child-bearing potential and not using an adequate 
contraceptive method (adequate contraceptive measure as required 
by local regulation or practice).  
 
Duration of study:  
Participation can last up to a week, which includes a 1-hour Screening 
Visit, an optional 7-day screening period, and a 2.5-hour Visit 1. 
Screening Visit and Visit 1 may take place at the same day depending on 
the preference of participants, however, Visit 1 must be conducted 
entirely within one visit.  
 
2. Introduction 
The study will be conducted in compliance with this protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH-GCP)1 and applicable regulatory requirements 
(Section 11.1.1). In this document, the term investigator refers to the individual responsible for 
the overall conduct of the clinical study at a study site. 

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2.1 Background  
2.1.1 Chronic Obstructive Pulmonary Disease 
Chronic Obstructive Pulmonary Disease (COPD) is characterized by progressive airflow blockage 
and breathing-related problems. COPD was the third leading cause of death in the United States 
in 2014 and is projected to be the fourth leading cause of death worldwide and seventh in 
morbidity burden by 20301,3. Smoking is by far the greatest risk factor for COPD.  Other risk 
factors include exposure to air pollution, genetics, airway hyper-responsiveness, and poor lung 
growth during childhood4. COPD severity can be stratified with the use of spirometry, which is a 
series of tests to measure the volume of air a patient can inhale, the volume of air a patient can 
exhale, and how quickly a patient can exhale. COPD treatment options depend directly on the 
severity of a patient’s condition. Therapy options for COPD symptoms include: smoking 
cessation, pharmacologic therapy, coaching on inhaler technique, vaccinations against respiratory 
diseases, and pulmonary rehabilitation5.  
2.1.2 Long-term oxygen therapy 
Long-term oxygen therapy (LTOT) is prescribed for patients whose COPD is considered severe. 
LTOT is defined by the British Thoracic Society as ≥15 hours of oxygen use per day6. Oxygen is 
provided continuously to the patient in either a continuous-flow or pulsed delivery pattern. 
Patients with more significant COPD symptoms are expected to benefit from LTOT as it has been 
shown to improve survival, exercise, sleep, and cognitive performance7. LTOT systems include 
oxygen concentrators (OC), liquid oxygen (LO) and portable oxygen concentrators (POCs). OCs 
remain the most economical way to provide oxygen at home. Many modern LTOT users are 
considered highly active and ambulatory when compared to their historic counterparts, who often 
were considered truly homebound8, 9. However, to comply with physician prescription to breathe 
oxygen for ≥ 15 hours per day, patients using many of the LTOT modalities are forced to stay at 
home and to limit their outdoor activities.  
2.1.2.1 Oxygen Cylinders – Liquid or Gas 
Oxygen is delivered to the patient either via a flow meter attached to the cylinder or via an oxygen 
conservation device. Unlike continuous flow devices, oxygen conservation devices deliver oxygen 
predominantly during inspiration and therefore avoid wastage caused by oxygen flow during 
expiration. The most common oxygen conservation devices are ‘demand flow’, which deliver a 
pre-set volume or bolus of oxygen in early inspiration. Another type of oxygen conservation 
device consists of a nasal cannula set with an integrated pendant-shaped reservoir that fills with 
oxygen during exhalation and delivers a bolus of oxygen during subsequent inspiration.10.A less 
efficient combination is the use of an OC at home and pressurized oxygen in small lightweight 
cylinder for ambulation. Need for frequent refilling and cumbersome logistics make this source 
less convenient9, for this reason, POCs represent a higher level of convenience as compared to 
other ambulatory systems (e.g., LO)8. 
2.1.2.2 Portable Oxygen Concentrators 
Like stationary OCs, POCs separate nitrogen from ambient air and are capable of delivering 93–
95% oxygen at a rate of 3–4 L/min. They are small and lightweight (maximum weight 4 kg for 
intermittent flow systems, or 9 kg for continuous flow systems) and can be powered by electricity, 
car, or rechargeable batteries11. Two types of POCs are available: continuous flow and pulse flow. 
Unlike continuous flow oxygen, pulse flow devices provide a pre-set oxygen bolus (measured in 
milliliters per breath) during the first 60% of inspiration thus reducing oxygen waste. The pulse 
flow system is capable of delivering the same volume of oxygen per breath, regardless of 
respiratory rate. 

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POCs, such as Mobi™, have been shown to  help improve moderate to severe COPD patient’s 
functional ability, quality of life, prevent emergency room encounters, and hospital admissions by 
increasing compliance with oxygen therapy12. There may be some improvements in quality of life 
with use of POCs compared with liquid oxygen cylinders, but study results are inconsistent13. 
2.2 Rationale for the Study 
Mobi™ is a relatively new POC in the market and thus it is valuable to compare data from COPD 
patients using supplemental oxygen against data from Mobi™ use during ambulation. The purpose 
of the present study is to compare Mobi™ with a continuous flow oxygen cylinder, with mean 
SpO2 during a 6MWT as the primary endpoint.  
3. Description of the Medical Devices 
3.1  Portable Oxygen Concentrator (POC) 
Mobi™ is indicated for patients who require supplemental oxygen, including COPD patients. It 
provides supplemental, high oxygen concentration to these patients. It is available via prescription 
only and may be used in the home, institution, and hospital settings, as well as travel environments 
as the Mobi™ is portable.  
3.1.1 Reprocessing the device 
When the device is used for multiple patients, the device should be cleaned between each 
participant per the Mobi™ Provider Guide15. The nasal cannula and inlet air filter should be 
disposed of and replaced between patients.  
3.2 Portable Oxygen Cylinder 
Participant will use a portable, continuous flow E oxygen cylinder provided by the study site as a 
comparison. 
3.3 Other Medical Devices 
3.3.1 SpO2 Monitoring 
Pulse oximeter oxygen saturation (SpO2) and pulse rate are monitored continuously with approved 
devices.  
3.3.1.1 Oximeter 
The PalmSat 2500 oximeter (Nonin Medical, Inc) will be used in this study. Trained study staff 
will place the oximeter on the patient’s non-dominant forefinger just before beginning each 
6MWT. This study staff representative will hold the oximeter device during the 6MWT, so they 
can continuously monitor the SpO2 levels of the patient during this assessment. 
4. Objectives and endpoints 
4.1 Objectives 
4.1.1 Primary objective 
To compare mean oxygen saturations (SpO2) between using the Mobi TM and an oxygen 
cylinder during the Six Minute Walk Tests (6MWTs). 

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4.1.2 Secondary objective 
To evaluate participant experience when using Mobi™ and an oxygen cylinder whilst walking, 
levels of dyspnea and distance covered during the 6MWTs. 
4.2 Endpoint 
4.2.1 Primary endpoint 
Mean SpO2 during Six Minute Walk Tests (6MWTs) for use of Mobi™ compared use of 
oxygen cylinder. 
4.2.2 Secondary endpoints 
 Distance covered during the 6MWTs. 
 Post-6MWT SpO2 
 Time spent ≥ 90% SpO2 during 6MWT 
 Participant acceptance questionnaire around ease of use and other aspects specific to 
portable oxygen use 
 Dyspnea and fatigue levels measured by Modified Borg scale (mBorg) 
5. Study Design 
5.1 Study Design 
This is a prospective, randomized, cross-over study design with participants serving as their own 
controls. Eligible participants will complete two 6MWTs: one while using portable oxygen 
cylinder and one while using Mobi™. All participants entered into the study will be randomized 
to complete a 6MWT with either of the following devices in a cross-over fashion, with a one-
hour wash-out period between tests: 
 Control device (portable oxygen cylinder) first; or  
 Study device (Mobi™, POC) first.  
5.2 Study Site(s) 
One (1) site in the United States will be approved to enroll participants in this study. Minimum 
criteria for study site qualification will be documented in the site qualification questionnaire, and 
filed in the Trial Master Files.  Sites that initially meet the minimum criteria may be visited by a 
qualified monitor to further discuss study details, requirements, and expectations, as well as to 
ascertain adequacy of site facilities. Qualified site will be provided with the study documents 
necessary for IRB submission.  Site readiness will be determined prior to enrollment of the first 
participant at the study site, and is contingent upon the electronic filing of final IRB approval letter 
and all other critical study documents. 
5.3 Participant recruitment 
The participants will be recruited by qualified study staff at the study site via flyer and/or 
telephone contact. Participants who may be interested in taking part will be told about the study 
details, and qualified study staff will go through the Informed Consent Form process with them. 
Participants are encouraged to ask questions and/or consult with family members with any 
questions on the study.  Participant’s that sign the Informed Consent Form may enroll into this 
study. 

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6. Study Population   
Eligible COPD participants using home oxygen will be included in this study and the dropout rate 
is anticipated to be 5%.   
6.1 Number of Study Participants 
Number of participants planned to be screened: up to 100 
Number of participants planned to be randomized: 32 
6.2 Inclusion Criteria  
Participants must meet all of the following inclusion criteria to be eligible for participation in this 
study: 
1. Participant has given informed consent before any study-related activities. Study-related 
activities are any procedures that are carried out as part of the study, including activities 
to determine suitability for the study.  
2. Participant is male or female, age ≥ 18 years, at the time of signing informed consent.  
3. Participant has been diagnosed with COPD and is currently in a stable state (at least 4 
weeks since the last exacerbation episode). 
4. Participant is currently prescribed long-term oxygen therapy. 
5. Participant meets the criteria for pulse-dose portable oxygen delivery. Criteria is defined 
as being mobile within the home and has undergone a qualifying blood gas study at rest 
(awake) or during exercise.    
6. Participant can read and comprehend English. 
6.3 Exclusion Criteria   
Participants who meet any of the following exclusion criteria are not to be enrolled in this study: 
 
1. In the investigator’s opinion, participant is clinically unstable and their participation may 
jeopardize the participant’s safety or compliance with the protocol. 
2. Participant is currently prescribed long-term oxygen therapy of  >5 L/min continuous flow. 
3. Participant has a known or suspected contraindication for pulse-dose oxygen (e.g. using 
the device for life-sustaining or life-supporting purposes).  
4. Participant is unavailable to complete 6MWTs (e.g., unstable angina and myocardial 
infarction during the previous month16).  
5. Participant is a female who is pregnant, breast-feeding, or intends to become pregnant, or 
is of child-bearing potential and not using an adequate contraceptive method (adequate 
contraceptive measure as required by local regulation or practice).  
7. Study Procedures 
Participation includes a 1-hour Screening Visit, up to 7-days screening period (optional), and a 
2.5-hours Visit 1. Screening Visit and Visit 1 may be combined depending on the preference of 
participants. Each participant is to attend both visits at the site. The Investigators must document 
any deviation from study procedures and notify ResMed.  
7.1 Screening Visit 
7.1.1 Participants will be screened to determine eligibility for participation in the study. Before 
any study-related activity, the Investigator or designee must provide the subject with the 
Informed Consent Form, explaining the trial and the procedures involved. Each potential 

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participant must sign and date the Informed Consent Form before any study-related activities are 
performed. Once a person agrees to participate in this trial, by signing and dating the Informed 
Consent Form, the following will be performed and documented at screening: 
7.1.2 Demography 
Demography will be recorded in the eCRF at screening and consists of: 
 Date of birth 
 Sex 
 Ethnicity 
 Race 
7.1.3 Body weight and height 
Body weight (with an empty bladder, without shoes and only wearing light clothing) must be 
measured and recorded in the eCRF in kilogram or pound (kg or lb), to one decimal place. The 
body weight should be assessed on the same scale throughout the study, if possible. 
 
Height (without shoes) is measured in centimeters or inches (cm or in), and recorded in the eCRF 
to the nearest ½ cm or ¼ inch. 
7.1.4 COPD history and comorbidities 
 Date of diagnosis of COPD  
 Stage of COPD, if known 
 Comorbidities 
 History of Pulmonary Rehabilitation: last date of Pulmonary Rehabilitation 
7.1.5 Medical history 
Medical history is a medical event that the participant has experienced in the past. Only relevant 
medical history as judged by the investigator should be reported. 
 
The information collected for medical history includes diagnosis, date of onset and date of 
resolution or continuation, as applicable. 
7.1.6 Concomitant medication 
In this study, only medications related to respiratory disease will be collected, as well as if a 
participant is using an antianginal medication. All relevant medications in use at time of 
screening through completion of the study will be recorded. 
 
Details of any concomitant medication must be recorded at the screening visit. Changes in 
concomitant medication must also be recorded (for example, if participant completes Visit 1 on 
a different date than Screening visit). 
7.1.7 Oxygen prescription 24 
 Long-term oxygen therapy history 
 POC use history 
 Normal practice with oxygen use during ambulation/exertion 
 
Participants meeting all of the inclusion criteria and none of the exclusion criteria are qualified to 
enroll in this study. A qualified participant can continue to Visit 1 immediately, or return to the 
investigational site within 7 days. 

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7.2 Visit 1 
Eligible participants will be randomized into one of two study groups, which will define the order 
in which they use the control device or Mobi™ device during the 6MWT. The overall Visit 1 
procedure is presented graphically in Figure 7-1: 
 
 
 
Figure 7-1 
  
The order of 6MWTs will be randomized within the EDC, and in each of the two 6MWTs the 
participants will use either: 
 Mobi™; or 
 A portable oxygen cylinder.  
 
Site staff will pull the oxygen cylinder via a trolley or carry the Mobi™ device via its carrying 
bag. This will ensure consistency across tests. 6MWTs will be conducted according to current 
ERS/ATS field test guidelines16,17.   
7.2.1 Prior to 6MWT 
Prior to 6MWT, the following will be performed and documented: 
7.2.1.1 Oxygen titration 
Each participant will undergo titration using MobiTM to reach SpO2 of ≥90%. After the MobiTM 
titration, each participant will rest for at least 1 hour while breathing their supplemental oxygen 
device to obtain resting SpO2 levels. Participants shall have a resting SpO2 of ≥90% prior to 
starting each 6MWT.  
During use of the oxygen cylinder 6MWT, the settings will be based on the patient’s original 
prescription.   
During the use of the Mobi™ device 6MWT, the patient will use Mobi™ based on the titrated 
Mobi™ setting.   
After starting therapy, the site staff should also wait for approximately 5 minutes to make sure no 
alarms turn on. Both of these oxygen system settings will be recorded.  
7.2.1.2 Vital signs 
 Respiratory rate 
 Systolic and diastolic blood pressure should be measured in a sitting position after the 
participant has been resting and by using the standard clinical practice at the site. 
 Pulse (beats per minute) must be recorded after the participant has been resting for 5 
minutes in a sitting position. 

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7.2.1.3 Modified Borg scale 
Each participant will rate their baseline dyspnea and fatigue levels using the modified Borg scale 
(see Appendix 4) and move to the starting point 
7.2.2 During 6MWT 
During each 6MWT, the following will be measured25: 
 SpO2 
 Time to participant’s first rest, if applicable 
 Distance at point of participant’s first rest, if applicable 
 Number of rest times, if applicable 
 6MWD 
 
If the participant uses walking aids (cane, walker, etc.), these aids should be used during each 
6MWT. 
Trained study staff will walk alongside the participant for each 6MWT. This study representative 
will carry the SpO2 monitor, and monitor the participant during the walk, assessing for any 
variables that may require the participant to rest or terminate the test (eg: study representative may 
terminate the 6MWT if the participant’s SpO2 is below 80%). 
7.2.3 Post 6MWT 
Post each 6MWT, participants will record  
 Respiratory rate 
 Pulse (beats per minute) 
 Post-walk dyspnea and fatigue levels measured by the Modified Borg scale 
 
Before the next 6MWT, participants will rest for at least 1 hour breathing their supplemental 
oxygen device prior to switching to the alternate device for the second test. 
 
After each of the two 6MWTs, participants will complete a participant acceptance questionnaire 
involving questions about ease of use and other aspects specific to portable oxygen use. 
7.3 End of Study 
End of study is considered to be the completion of Visit 1. There is no follow up period.  

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8. Adverse Events 
8.1 Definitions 
8.1.1 Adverse Event 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in 
participants, whether or not related to the investigational medical device. 
 
An AE includes: 
 A clinically significant worsening of a pre-existing condition. 
 
The following should not be reported as AEs: 
 Pre-existing conditions, including those found as a result of screening or other study 
procedures performed before exposure to study product (pre-existing conditions should be 
reported as medical history or concomitant illness). 
 Pre-planned procedures, unless the condition for which the procedure was planned has 
worsened from the first study related activity after the participant has signed the informed 
consent. 
 
The following three definitions are used when assessing an AE: 
 Severity  
– Mild - no or transient symptoms, no interference with the participant’s daily activities. 
– Moderate - marked symptoms, moderate interference with the participant’s daily 
activities. 
– Severe - considerable interference with the participant’s daily activities; unacceptable. 
 Causality  
Relationship between an AE and device(s):  
– Unrelated: The event is due to the underlying disease state or concomitant medication or 
therapy not related to the study-specific devices or procedures. 
– Unlikely related:  The event had no significant temporal relationship to the study-specific 
devices or procedures and/or a more likely alternative etiology exists. 
– Possibly related: The event had a strong temporal relationship to the study-specific 
devices or procedures and alternative etiology is equally or less likely compared to the 
potential relationship to the study-specific devices or procedures.  
– Probably related: The event had a strong temporal relationship to the study-specific 
devices or procedures and another etiology is unlikely. 
– Unknown:  Relationship of the event to the study-specific devices or procedures and 
alternative etiology is unknown 
 Final outcome 
– Recovered/resolved - The participant has fully recovered, or by medical or surgical 
treatment the condition has returned to the level observed at the first study -related activity 
after the participant signed the informed consent. 
– Recovering/resolving - The condition is improving and the participant is expected to 
recover from the event. This term is only applicable if the participant has completed the 
study or has died from another AE. 

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– Recovered/resolved with sequelae - The participant has recovered from the condition, 
but with lasting effect due to a disease, injury, treatment or procedure. If a sequelae meets 
an SAE criterion, the AE must be reported as an SAE. 
– Not recovered/not resolved - The condition of the participant has not improved and the 
symptoms are unchanged, or the outcome is not known. 
– Fatal - This term is only applicable if the participant died from a condition related to the 
reported AE. Outcomes of other reported AEs in a participant before he/she died should 
be assessed as “recovered/resolved”, “recovering/resolving”, “recovered/resolved with 
sequelae” or “not recovered/not resolved”. An AE with fatal outcome must be reported as 
an SAE. 
– Unknown  
8.1.2 Serious Adverse Event 
A serious adverse event is an adverse event that:  
 Leads to death, or 
 Leads to serious deterioration in the health of a participant that: 
o results in a life-threatening illness or injury, 
o results in permanent impairment of a body structure or body function, 
o requires inpatient hospitalization or prolongation of existing hospitalization, 
o results in medical or surgical intervention to prevent permanent impairment to a 
body structure or a body function. 
 Leads to fetal distress, fetal death or a congenital abnormality or birth defect. 
8.1.3 Anticipated Adverse Events 
Warnings, contraindications, and hazards are outlined in the User Manual for Mobi™ and should 
be reviewed with participants when they receive their study devices.  All study devices are to be 
used in accordance with their respective approved, current instructions found in the manual14. 
Anticipated adverse events include events that are reasonably expected to occur as a result of the 
participant’s disease state or treatment. 
8.1.3.1 COPD-related Anticipated Adverse Events:   
 COPD exacerbation and related symptoms anticipated during this study include: 
o Cough 
o Dyspnea (shortness of breath) 
o Excessive mucus production 
o Wheezing 
o Chest tightness 
o Cyanosis 
 Lack of energy (fatigue) 
8.1.3.2 LTOT-related Anticipated Events18: 
Adverse events associated with LTOT during this study include, but are not limited to, the 
following: 
 Nosebleed 
 Dry mouth 
 Dry throat 
 Headache 

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 Tripping/falling over equipment 
 Noise irritation 
8.2 Adverse Event Assessment and Reporting 
8.2.1 Adverse Event Assessment 
Adverse event information will be collected on all participants.  At every participant encounter 
throughout the study, the investigator will inquire about adverse events since the last encounter.  
8.2.2  Adverse Event Reporting 
Adverse events (AEs) are to be reported in the electronic study database on an AE eCRF as soon 
as possible after discovery by the site and are to be updated with new information and upon final 
resolution of the event.  Supporting source documents for SAEs may be requested; if requested, 
these documents are to be de-identified, labeled with the participant number, and an email will be 
promptly provided or uploaded to the electronic study database.  Adverse events will be evaluated 
by the investigator and classified for seriousness (as defined in Section 8.1.2), relatedness, and 
severity.  
8.2.3 For US only: Mandatory Medical Device Reporting  
Manufacturers are required to report to the FDA via an electronic equivalent of Form 3500A when 
they learn that any of their devices may have caused or contributed to a death or serious injury or 
has malfunctioned and the malfunction would be likely to cause or contribute to a death or serious 
injury if it were to recur (key terms are defined in 21 CFR 803.3.).   Manufacturers must also 
report to the FDA when they become aware that their device has malfunctioned and would be 
likely to cause or contribute to a death or serious injury if the malfunction were to recur.  Should 
such an event occur during this study, the appropriate device manufacturer will file Form 3500A 
with FDA’s Center for Devices and Radiological Health as required by law. 
8.2.4 Device Deficiency 
Inadequacy of a medical device related to its identity, quality, durability, reliability, safety or 
performance, such as malfunction, misuse or use error or inadequate labelling. 
 
The investigator shall record every Device Deficiencies with assessment on the study Case Report 
Forms (CRF) (paper or electronic). 
 
All Device Deficiencies assessed by the investigator that may have led to (had the potential to 
lead to) an SAE, if appropriate action had not been taken, intervention had not occurred, or 
circumstances had been less fortunate are treated as the same reporting category as SAEs and must 
be reported accordingly to the SAE process 
9. Risk and Benefits  
9.1 Potential Risks 
Refer to Section 8.1.3 for a list of potential risks. 
9.1.1 Minimization of Risks 
This study involves the use of a FDA-cleared, Class II medical device and CE marked devices 
that deliver oxygen therapy with no greater than minimal risk to participants.  All study devices 
will be used in accordance with their respective approved indications and instructions.  

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As per FDA good practice guidelines (21 CFR 10.115), this study protocol as well as the Mobi™ 
device was assessed for risk to participants. As this study does not meet the definition of 
significant risk as defined by 21 CFR 812.3(m), the investigative team has determined that this 
protocol and the Mobi device is non-significant risk.    All participants will maintain all other 
therapy regimens per standard clinical care; this protocol does not dictate any other adjustments 
to the participants’ care regimen and there are no protocol-required assessments or procedures that 
pose significant risk to the participants. As required by the FDA, the IRB will review this study 
protocol and make the final determination of NSR designation. 
 
Participants should be encouraged to discuss any issues they are having with therapy during the 
study. The investigator should assess for changes in the health or well-being of the participant in 
response to general, non-directed questioning (e.g., “How are you feeling while using the 
therapy?”).  Side effects should be documented on the site’s source documents. Furthermore, if 
during the evaluation the participant cannot complete an assessment, the participant may sit down 
until they feel stable to continue.  Potential expected adverse events are believed to be mild and 
similar to other commercially available POC systems. 
 
The attending study staff have experience setting up the eligible patient population in this study.  
All participants return to their current oxygen therapy after completing the study visits. 
The following will be performed to minimize risks: 
9.1.1.1 Safety assessments 
During this study, participants SpO2 and heart rate will be monitored before, during and 
immediately following the walk to ensure devices connectivity and to ensure participant safety19. 
  
9.1.1.2 Site staff training and experience 
A delegated site staff will be present during each session with participants. A delegated site staff 
should be certified in cardiopulmonary resuscitation with a minimum of Basic Life Support by an 
American Health Association–approved cardiopulmonary resuscitation course. Advanced cardiac 
life support certification is desirable. Training, experience, and certification in related health care 
fields (registered nurse, registered respiratory therapist, certified pulmonary function technician) 
are also desirable.  
9.1.1.3 6MWT guidelines compliance 
6MWTs will be conducted according to the guidelines (ERS/ ATS) and participants will be 
followed by a delegated site staff. Safety check points for immediately stopping a 6MWT in ERS/ 
ATS guideline will be undertaken to minimize risk associated with this test. A delegated site staff 
must recognize these problems and the appropriate responses. If in their clinical judgment there 
are signs of participant distress, the test session will be stopped and participants will be returned 
to their current oxygen device. 
9.2 Potential benefits 
There may be no benefits to participants from taking part in the study.  Benefits during the study 
may include: 
 Symptomatic relief from dyspnea. 
 Maintenance of SpO2 during 6MWTs. 
However, it is not expected that these benefits will last longer than the duration of the study. 

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10. Statistical Considerations 
10.1 Primary Objective and Endpoint 
The primary endpoint is mean SpO2 measured during a 6 Minute Walk Test (6MWT).  The 
primary aim of this protocol is to show non-inferiority between the Mobi oxygen device and the 
control device with respect to mean SpO2 during the 6MWT. 
The null and alternative hypothesis is based on a one-sided non-inferiority test using a non-
inferiority margin (NIM) of 2%. 
H0: μA - μB ≤ -NIM (Mobi is inferior) 
H1: μA - μB > -NIM (Mobi is non-inferior) 
where μA and μB are the mean SpO2 after using the Mobi device (A) and the Control device (B), 
respectively, and NIM equals the non-inferiority margin.  A significant level of 0.025 will be used. 
10.2 Analysis Populations 
The populations are defined as follows. 
 
The Intent-To-Treat (ITT) is defined as all patients who meet the inclusion/exclusion 
criteria and begin the first 6MWT. 
 
The Completed Cases (CC) population is defined as all patients in the ITT population 
who complete both the first and second 6MWTs. 
The primary endpoint analysis will be based on the CC participant population.  A participant may 
rest during the 6MWT and still complete the test, however if the participant stops completely then 
the 6MWT will be considered incomplete.  A sensitivity analysis of the primary endpoint will be 
generated for the ITT population.  The ITT population may contain some participants who 
complete the first study 6MWT but not the second study 6MWT.  This will require the use of 
imputation methods for missing values which are documented in Section 10.9. 
All safety analyses will be generated for participants in the ITT population.  All secondary 
endpoints will be generated using the CC population. 
10.3 Statistical Analysis of the Primary Endpoint 
The primary hypothesis will be tested using a cross-over Analysis of Variance test (ANOVA).  
Specifically, a repeated-measures ANOVA with fixed treatment and period effect and random 
participant effects will be fit to the data. The mean difference between treatment effects will 
compared to a non-inferiority margin of -2%, using a Wald test.  Additionally, the 97.5% lower 
one-sided confidence bound for the mean paired difference in mean SpO2 between the Mobi 
device and the Control device will be calculated.   
10.4 Justification of Sample Size 
Based on a study by Khor et al.26, evaluating the clinical effectiveness of the Inogen One G2 
device compared to Continuous Oxygen Cylinder, the observed mean (standard deviation) in 
mean SpO2 during the 6MWT was 82.3% (3.5) for Inogen and 80.3% (2.2) for continuous oxygen.  
For estimating the SD of the difference, we assume that the SD for the Mobi device will be similar 
to the Inogen One G2 results.  The within patient correlation is assumed to be small, r=0.2. The 
standard deviation of the difference is 3.74, estimated using the following formula:  sqrt(SD12 + 

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SD22 – (2*r*SD1*SD2)), where SD1 and SD2 are the standard deviations for each study treatment 
and r is the correlation between the repeated measures (within a participant).   
Assuming a standard deviation of the difference is 3.74, a true mean difference between treatments 
of 0, and one-sided significance level of 0.025, a sample size of 30 provides 80% power to detect 
non-inferiority when the non-inferiority margin is -2.0.  This sample size was generated using the 
Non-Inferiority Tests for the Difference Between Two Means in a 2x2 Cross-over Design 
procedure, PASS Version 2019 software27.   Since both treatments will be completed during the 
same visit, a small drop-out rate is assumed at 5%.  Thus, a total of 32 (30/0.95) participants will 
be enrolled in the study, each participant randomized with respect to the order of treatment. 
10.5 General Statistical Analysis Guidelines 
Descriptive statistics will be used to summarize both continuous and categorical endpoints.  The 
number of observations, mean, median, standard deviation, standard error, minimum and 
maximum will be calculated for continuous variables, unless otherwise stated. The number of 
significant digits reported will be as follows: minimum and maximum will have the same number 
of significant digits as the raw data; the mean, median, standard deviation, and standard error will 
be reported with one more significant digit than the raw data. Frequencies and percentages will be 
calculated for categorical data using one significant digit for percentages. 
10.6 Baseline Characteristics and Medical History 
Demographic, baseline characteristics (age, sex, ethnicity, race, BMI), medical history and 
concomitant medications collected during the screening visit will be summarized descriptively for 
the ITT population. For continuous variables, the mean, standard deviation (SD), number 
evaluated, median, minimum and maximum will be provided. For categorical variables, the 
number with the characteristic, the number evaluated, and the percentage will be presented 
10.7 Statistical Analysis of Secondary Endpoints 
Secondary endpoints include post-6MWT oxygen saturation (SpO2), distance walked during the 
6MWT (6MWD), time spent ≥90% SpO2 during 6MWT, pre and post-6MWT modified Borg 
Dyspnea Scale, and acceptance questionnaires comparing patient experience and comfort between 
Mobi and Control treatments.  Descriptive statistics will be presented for each secondary endpoint 
by treatment group, including mean, standard deviation, median, median, inter-quartiles, 
minimum and maximum values.  A cross-over ANOVA with fixed treatment and period effects 
and random subject effects will be used to summarize the difference in means between treatment 
groups and the associated 95% confidence intervals for each secondary endpoint.   
10.8 Safety Analyses 
A listing of all adverse events occurring during the study period will be generated including all 
participants in the ITT population.  The listing will include the event description, time of 
occurrence, severity, outcome and action taken.  
10.9 Handling of Missing Values 
The primary endpoint analysis will be based on the CC population.  A sensitivity analysis will be 
done using the ITT population and a mixed-effects cross-over analysis.  The mixed-effects 
analysis uses maximum likelihood to estimate parameters when there are missing values and is 
appropriate when data is missing at random (MAR). 

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11. Responsibility  
11.1 Investigator Responsibilities 
11.1.1 Statement of Compliance 
This study shall be conducted: 
• 
In accordance with the ethical principles that have their origin in the Declaration of 
Helsinki20; 
• 
FDA good practice guidelines (21 CFR 10.115) 
• 
In compliance with ISO14455:2011: the National Statement on Ethical Conduct in 
Human Research21; 
• 
Under ethics approval;  
• 
Under regulatory approval; and 
• 
With appropriate insurance.  
11.1.2 Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Ethics 
Committee (EC) Review and Approval 
The Investigator (or sponsor, as appropriate according to local regulations) will submit this 
protocol, ICF, and any accompanying material to be provided to the participant (such as 
advertisements, participant information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB/IEC/EC. The Investigator will not begin any study participant 
activities until approval from the IRB/IEC/EC has been documented and provided as a letter to 
the Investigator. Before implementation, the investigator will submit to and receive documented 
approval from the IRB/IEC/EC of any modifications made to the protocol or any accompanying 
material to be provided to the participant after initial IRB/IEC/EC approval, with the exception of 
those necessary to reduce immediate risk to study participants. 
11.1.3 Informed Consent Process 
Written informed consent shall be obtained for all study participants. Informed consent involves 
the process through which potential participants learn about the study, and make the informed 
decision on whether they wish to take part. This includes the participant being able to ask any 
questions they may have, and have ample time to consider the study. The participant is encouraged 
to consult with their GP and/or family members before making the decision to participate in the 
study. 
 
All participation is voluntary and participants have the right to withdraw at any time for any 
reason. 
Informed consent shall be gained through the researcher explaining the study to the participant, 
allowing them to read the participant information statement and informed consent form, and ask 
any questions they may have. If they are happy to continue they should sign and date the consent 
form. The investigator will then also sign and date the form. A second copy will be signed for the 
participant’s records.  
11.1.4 Confidentiality 
The investigator must assure that participants’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only partial date of birth (as applicable in 
certain countries), another unique identifier (as allowed by local law), and an identification code 
will be recorded to the Sponsor or IRB/IEC/EC. 
  

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NOTE: The investigator must keep a screening log showing codes, names, and addresses for all 
participants screened and for all participants enrolled in the study. Participant data will be 
processed in accordance with all applicable regulations. 
 
The investigator agrees that all information received from ResMed, including but not limited to 
this protocol, eCRFs, the device, and any other study information, remain the sole and exclusive 
property of ResMed during the conduct of the study and thereafter. This information is not to be 
disclosed to any third party (except employees or agents directly involved in the conduct of the 
study or as required by law) without prior written consent from ResMed. The investigator further 
agrees to take all reasonable precautions to prevent the disclosure by any employee or agent of the 
study site to any third party or otherwise into the public domain. 
12. References   
1. International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. 
Guideline for Good Clinical Practice E6(R1) 
2. Am J Respir Crit Care Med. 2016 Dec 15;194(12):1483-1493 
3. Projections of global mortality and burden of disease from 2002 to 2030; Mathers CD et 
al. PloS Med. 2006 Nov;3(11):442 
4. COPD National Action Plan, Centers for Disease Control and Prevention, 2017  
5. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global 
Initiative for Chronic Obstructive Lung Disease; Vogelmeier CF  et al. Respirology. 2017 
Apr;22(3):575-601 
6. British Thoracic Society guidelines for home oxygen use in adults: accredited by NICE; 
Hardinge M; Thorax. 2015 Jun;70 Suppl 1:1-43 Standards for the diagnosis with COPD: 
a summary of the ATS/ERS position paper; B.R. Celli et al.; Eur Respir J. 2004 
Jun;23(6):932-46 
7. Oxygen Conserving Devices: Optimizing the Benefit; Joseph S. Lewarski et al.; AARC 
Tımes 2016 
8. Perceived Satisfaction With Long-Term Oxygen Delivery Devices Affects Perceived 
Mobility and Quality of Life of Oxygen-Dependent Individuals With COPD; Mussa CC 
et al.; Respir Care. 2018 Jan;63(1):11-19 
9. Ambulatory Oxygen for Exercise-Induced Desaturation and Dyspnea in Chronic 
Obstructive Pulmonary Disease (COPD): Systematic Review and Meta-Analysis; Stanley 
I et al., Chronic Obstr Pulm Dis. 2016; 3(1): 419-434 
10. The Clinical Impact of New Long-Term Oxygen Therapy Technology; Dunne PJ. Et al., 
Respir Care. 2009;54(8):1100–11 
11. Oxygen-conserving techniques and devices; McCoy R. et al., Respir Care 2000;45(1):95-
103 
12. A Prospective Observational Study to Evaluate the Use of a Lightweight (<5 lbs) Pulse 
Wave Delivery Portable Oxygen Concentrator (POC) to Improve the Quality of Life and 
Outcomes of Patients Who Are Diagnosed With Chronic Obstructive Pulmonary Disease 
(COPD) and Require Long-term Oxygen Therapy (LTOT); Pertelle V et al; October 2014 
Volume 146, Issue4, Supplement 2, Page 525A 
13. Oxygen Therapy for Patients With COPD: Current Evidence and the Long-Term Oxygen 
Treatment Trial; Stoller JK et al.; Chest. 2010;138(1):179–87. 
14. Mobi user guide 
15. Mobi provider guide 
16. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 
Jul 1;166(1):111-7 

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17. ATS Statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2016 
May 15;193(10):1185 
18. A Randomized Multi-Arm Repeated-Measures Prospective Study of Several Modalities 
of Portable Oxygen Delivery During Assessment of Functional Exercise Capacity 
Comparing supplementary oxygen benefits from a portable oxygen concentrator and a 
liquid oxygen portable device during a walk test in COPD patients on long-term oxygen 
therapy Respir Med. 2008 Jul;102(7):1021-5 
19. A multi-center randomized study that compared the clinical efficacy of the LifeChoice 
Activox Portable Oxygen Concentrator (POC) featuring PULSE-WAVE® Technology to 
traditional continuous liquid oxygen therapy C1000; Jean-François Muir et al 
20. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical 
Research Involving Human Subjects. Last amended by the 64th WMA General Assembly, 
Fortaleza, Brazil. October 2013. 
21. In compliance with ISO14455:2011; the National Statement on Ethical Conduct in 
Human Research; 2007 
22. Clinical Effectiveness of LifeChoice ActivoxTM Medical Device: Clinical Evaluation 
December 2013; French National Home Care Association for Chronic Respiratory 
Insufficiency 
23. A Randomized Multi-Arm Repeated-Measures Prospective Study of Several Modalities 
of Portable Oxygen Delivery During Assessment of Functional Exercise Capacity; 
Respiratory Care  March 2009,  54  (3)  344-349; Shawna L et al. 
24. Patient Perceptions of the Adequacy of Supplemental Oxygen Therapy. Results of the 
American Thoracic Society Nursing Assembly Oxygen Working Group Survey; Annals 
ATS volume 15, January 2018; Jacobs et al 
25. Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients 
With COPD; Chest April 2017 Volume 151, Issue 4, Pages 795–803; Jarosch et al. 
26. Portable oxygen concentrators versus oxygen cylinder during walking in interstitial lung 
disease: A randomized crossover trial; Respirology 2017,22, 1598–1603; Khor et al. 
27. PASS 2019 Power Analysis and Sample Size Software (2019). NCSS, LLC. Kaysville, 
Utah, USA, ncss.com/software/pass. 
 
 
 

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