Nasal High Flow (NHF) Therapy Use Following Hospitalization for an Exacerbation of COPD: A Feasibility Study
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Sponsor: Fisher and Paykel Healthcare

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Title: Nasal High Flow (NHF) therapy use following hospitalization for an exacerbation 
of COPD: A feasibility study 
Acronym: N3ADS (Nasal high flow therapy 30 day readmission Study) 
Study Phase: III 
Sponsor: Fisher and Paykel Healthcare Limited, New Zealand 
Principal Investigator: Doctor James FINGLETON 

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Table of Contents 
 
1. 
REVISION HISTORY ................................................................................................... 4 
2. 
LIST OF ABBREVIATIONS ........................................................................................... 4 
3. 
MONITORING ARRANGEMENTS AND DATA MANAGEMENT ............................................. 4 
3.1. 
Monitoring arrangements 
4 
3.2. 
Data Management 
5 
4. 
INVESTIGATOR INFORMATION .................................................................................... 5 
4.1. 
Primary Investigator 
5 
4.2. 
Coordinating Investigator 
5 
4.3. 
Other Investigators 
5 
4.4. 
Institution 
6 
4.5. 
Other 
6 
5. 
SPONSOR INFORMATION ............................................................................................ 7 
6. 
DEVICE INFORMATION .............................................................................................. 7 
6.1. 
Identification of the Medical Device 
7 
6.2. 
Device Risk Analysis and Management 
7 
7. 
JUSTIFICATION FOR A CLINICAL TRIAL ........................................................................ 8 
7.1. 
Synopsis 
8 
7.2. 
Literature Review 
8 
7.3. 
Preclinical Testing 
8 
7.4. 
Previous Clinical Experience 
8 
7.5. 
Justification for Administration 
9 
8. 
OBJECTIVES OF THE CLINICAL INVESTIGATION ............................................................ 9 
8.1. 
Hypothesis 
9 
8.2. 
Objectives 
9 
8.3. 
Population 
9 
8.4. 
Risks & Benefits 
9 
8.5. 
Essential Requirements of the Relevant Directive 
10 
9. 
CLINICAL INVESTIGATION DESIGN ............................................................................ 10 
9.1. 
Type of Investigation 
10 
9.2. 
Controls 
10 
9.3. 
Bias 
10 
9.4. 
End Points 
10 
9.5. 
Variables 
11 
9.6. 
Measurements 
11 
9.7. 
Equipment 
12 
9.8. 
Inclusion / Exclusion criteria 
12 
9.9. 
Point of Enrolment 
12 
 
Patient Procedure 
12 
9.10. 12 
9.10.1. Flowchart 
12 
9.10.2. Interventions 
12 
9.10.3. Pre-discharge assessments and training 
13 
9.10.4. Post-discharge methods 
13 
9.10.5. myAIRVO 2 domiciliary oxygen assessment and prescription 
14 
9.10.6. Excluded participants 
15 
9.10.7. Associated documents 
15 
9.11. Withdrawal Criteria 
15 
9.12. Number of Trial Subjects 
15 

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9.13. Follow up Plan 
15 
9.14. Foreseeable Complications 
16 
10. CLINICAL TRIAL DOCUMENTATION .......................................................................... 16 
10.1. Consent and Recruitment 
16 
10.2. Case Report Forms 
16 
10.3. Insurance Statement 
16 
10.4. Record of Deviations 
16 
11. STATISTICAL CONSIDERATIONS ................................................................................ 16 
11.1. Description of the Statistical Design 
16 
11.2. Sample Size 
17 
11.3. Pass/Fail Criteria 
17 
11.4. Statistical Termination 
17 
11.5. Statistical Procedure Deviations 
17 
11.6. Selection Criteria 
17 
11.7. Statistical Data Management 
17 
12. ADVERSE EVENTS AND TERMINATION ...................................................................... 17 
12.1. Emergency Contact Details 
17 
12.2. Foreseeable Adverse Events 
17 
12.3. Reporting Adverse Events 
17 
12.4. Early Termination 
18 
12.4.1. Investigator 
18 
12.4.2. Sponsor 
18 
12.4.3. Institutional Review Board (IRB) or Independent Ethics Committee (IEC)18 
13. PUBLICATION POLICY ............................................................................................. 18 
14. APPROVAL ............................................................................................................. 18 
15. REFERENCES .......................................................................................................... 20 
16. APPENDIX 1: FLOWCHART .................................................................................... 21 
17. APPENDIX 2: TRAINING SESSION REQUIREMENTS ............................................. 22 
18. APPENDIX 3: INSURANCE CERTIFICATE .............................................................. 25 
 
 
 

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1. 
REVISION HISTORY 
Author 
Revision 
Date 
Description of change 
Janine Pilcher 
Sheng Feng 
A 
04/MAR/2015 
First release, this revision of the document is also 
known as the REV_A_04MAR2015 referenced in the 
clinical research agreement and insurance agreement. 
Janine Pilcher 
Sheng Feng 
B 
09/APR/2015 
Revisions based on reviewer comments prior to NZ 
HDEC submission. 
Janine Pilcher 
Sheng Feng 
C 
30/APR/2015 
Revision to spirometry wording and time frame for 
recruitment 
Janine Pilcher 
Sheng Feng 
Melanie Moylan 
D 
24/AUG/2015 
Revisions based on review by Melanie Moylan (for 
detail see tracked changes document) 
Janine Pilcher 
Melanie Moylan 
James Fingleton 
E 
20/NOV/2015 
Revisions to oxygen titration methodology, time 
windows for phone calls and visits, event reporting, 
point of enrolment and training requirement. The 
clinical trials registration number has been added. 
Minor formatting changes to differentiate protocol from 
F&P internal documents. In addition, James Fingleton 
is to be made the new PI. 
2. 
LIST OF ABBREVIATIONS 
 
AE 
 
Adverse Event 
AECOPD 
Acute Exacerbation of Chronic Obstructive Pulmonary Disease 
COPD   
Chronic Obstructive Pulmonary Disease 
CIP 
 
Clinical Investigation Plan 
CRF 
 
Case Report Form 
ED 
 
Emergency department/Emergency room 
FEV1  
Forced expiratory volume in 1 second 
FVC 
 
Forced Vital Capacity 
GP 
 
General Practitioner 
IRB 
 
Institutional Review Board 
IEC 
 
Independent Ethics Committee 
NHF 
 
Nasal High Flow  
NZ 
 
New Zealand 
PI 
 
Principal Investigator 
SAE 
 
Serious Adverse Event 
SVC(in)  
Slow Vital Capacity (inspiratory) 
USA 
 
United States of America 
 
3. 
MONITORING ARRANGEMENTS AND DATA MANAGEMENT 
3.1. 
Monitoring arrangements 
Site/clinical monitoring to assure high quality trial conduct will be conducted by Fisher and Paykel Healthcare or 
its representative. "On site" monitoring of individual case histories, assessment of adherence to the protocol, 
ensure the ongoing implementation of appropriate data entry and quality control procedures, and general 
assessment of adherence to good clinical practices. 
 

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The monitor will be allowed, on request, to have access to all source documents needed to verify the entries on 
the CRF and other protocol-related documents; provided that subject confidentiality is maintained in agreement 
with international, national and local regulations. It will be the monitor’s responsibility to inspect the CRF at 
regular intervals throughout the study, to verify the adherence to the protocol and the completeness, consistency 
and accuracy of the data being entered on them.  
 
The investigator’s file will contain the protocol/amendments, financial disclosure form, CRFs and data 
clarification and query forms, HREC approval with correspondence, informed consent, staff curriculum vitae and 
authorization forms, screening and enrolment logs, and other appropriate documents/correspondence as per 
ICH/GCP and local regulations. 
3.2. 
Data Management  
Both physical and electronic copies of forms will be kept by the sponsor at FPH.  
4. 
INVESTIGATOR INFORMATION 
4.1. 
Primary Investigator 
Name: James Fingleton 
Address: Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington Regional 
Hospital, Newtown, New Zealand 
Email: James.Fingleton@mrinz.ac.nz 
Phone: +64 4 8050241 
Professional Position: Deputy Director 
 
4.2. 
Coordinating Investigator 
 
NEW ZEALAND COORDINATING INVESTIGATOR: 
Name: James Fingleton 
Address: Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington Regional 
Hospital, Newtown, New Zealand 
Email: James Fingleton@mrinz.ac.nz 
Phone: +64 4 8050241 
Professional Position: Deputy Director 
 
USA COORDINATING INVESTIGATOR: 
Name: Robert S. Pikarsky 
Address: Alana Healthcare 4713 Crossroads Park Drive, Suite 502, Liverpool, NY 13088 
Email:Robert.Pikarsky@Alanahealthcare.com 
Phone: +1 315 313 3399 
Professional Position: Regional Director of Operations (North East) 
 
4.3. 
Other Investigators 
 
Name: Janine Pilcher 
Address: Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington Regional 
Hospital, Newtown, New Zealand 
Email: Janine.Pilcher@mrinz.ac.nz 
Phone: +64 4 8050241 
Professional Position: Deputy Director 
 
 

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Name: Richard Beasley 
Address: Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington Regional 
Hospital, Newtown, New Zealand 
Email: Richard.Beasley@mrinz.ac.nz 
Phone: +64 4 8050147 
Professional Position: Director 
 
Name: Steve McKinstry 
Address: Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington Regional 
Hospital, Newtown, New Zealand 
Email: steve.mckinstry@mrinz.ac.nz 
Phone: +64 4 8050147 
Professional Position: Clinical Research Fellow 
 
Name: Julia Wright . 
Address: Crouse Hospital, 736 Irving Ave, Syracuse, New York 13210 
Email:Juliawright@crouse.org 
Phone: +1 315 470 7130 
Professional Position: Director – Respiratory Care & Sleep Services 
 
Name: Michael Maguire, DO . 
Address: Crouse Hospital, 736 Irving Ave, Syracuse, New York 13210 
Email: MikeMaguireDO@crouse.org 
Phone: +1 315 470 7111 
Professional Position: Critical Care Physician – Critical Care Associates 
 
4.4. 
Institution 
NEW ZEALAND INSTITUTION: 
 
Name: Medical Research Institute of New Zealand 
Address: Level 7, Clinical Services Building, Wellington Regional Hospital, Newtown, New Zealand 
Email: Denise.fabian@mrinz.ac.nz 
Phone: +64 4 8050147 
 
USA INSTITUTIONS: 
 
Name: Alana Healthcare  
Address: 4713 Crossroads Park Drive, Suite 502, Liverpool, New York, 13088, USA 
Email: Robert.pikarsky@alanahealthcare.com 
Phone: +1 315 313 3399 
Country of residence: United States 
 
Name: Crouse Hospital  
Address: 736 Irving Ave, Syracuse, NY 13210, USA  
Email: Juliawright@crouse.org 
Phone: +1 315 470 7130 
4.5. 
Other 
WHO Universal Trial Number (UTN): U1111-1158-9792 
ClinicalTrials.gov Identifier: NCT02552732 
 
 
 
 
 

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5. 
SPONSOR INFORMATION 
 
Name: Fisher & Paykel Healthcare Limited 
Address: 15 Maurice Paykel Place, East Tamaki, Auckland, New Zealand. 
Name of Sponsor contact person: Stanislav Tatkov 
Phone: +64 9 574 0100 
Email: Stanislav.tatkov@fphcare.co.nz 
Profession: Clinical Research Manager at F&P Healthcare 
 
6. 
DEVICE INFORMATION 
6.1. 
Identification of the Medical Device 
myAIRVO 2 is a humidifier with integrated flow generator that entrains room air and prescribed medical gases. 
The device then humidifies these gases through a chamber, which are delivered to the patient via a nasal cannula 
‘Optiflow+™’ via a heated breathing tube, as depicted in figure1 below.  Collectively both the device and the 
cannula deliver NHF therapy.  
 
 
Figure 1 ‘myAIRVO 2 and Optiflow+ cannula’ 
 
myAIRVO 2 is designed to deliver heated and humidified gas over a range of temperature settings (31°C, 34°C 
and 37°C) and variable flow rates (10 to 60 L/min). These settings help preserve compliance with the treatment 
regimen.  
 
6.2. 
Device Risk Analysis and Management 
The AIRVO 2 series devices (including myAIRVO 2) are designed and released to market, in accordance to the 
FPH design control procedures incorporating a Risk Management File, and governed by the medical device 
industry Standards:  
 
ISO-13485:2003  (Quality Systems - Medical Devices - Particular Requirements); and  
 
ISO-14971:2007  (Application of Risk Management to Medical Devices). 
 

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7. 
JUSTIFICATION FOR A CLINICAL TRIAL 
7.1. 
Synopsis 
The aim of this feasibility study is to provide data for a subsequent randomized controlled trial to investigate if 
patient outcomes will be improved after an acute COPD exacerbation using domiciliary NHF compared to 
standard care. This feasibility study will investigate the following: process, resources,  management and scientific 
aspects of delivering NHF as an adjunct therapy in COPD patients. 
7.2. 
Literature Review 
Chronic obstructive pulmonary disease (COPD) affects around 15% of the adult population of New Zealand, with 
AECOPD resulting in more than 9,000 hospital admissions per year.1 The burden of COPD is recognized 
internationally with high admission and readmission rates reported in the United States of America (USA),2  
Europe3 4 and  Australia.5 
 
There is increasing interest in the provision of NHF therapy to improve outcomes in patients with COPD. The 
myAIRVO 2 device is designed to deliver heated and humidified gases to provide respiratory support. Previous 
research in patients with COPD and bronchiectasis, has demonstrated to significantly reduce exacerbation days 
and time to first exacerbation, as well as improve lung function and quality of life.6 
 
myAIRVO 2 may provide direct benefit to patients recovering from AECOPD by providing airway hydration, 
improving mucocilliary clearance7 and increasing nasal temperature (to 37°C) which may reduce the risk of 
subsequent infection.8 As well as improving clinical outcomes, NHF therapy may reduce readmission rates 
conferring significant economic benefits. In the USA, 21% of admissions to hospital with AECOPD are followed 
by readmission within 30 days, and the costs of a second hospital stay are consistently higher when compared 
with the original admission.2 The proportion of patients that are readmitted within 30 days with a primary 
diagnosis of AECOPD in the USA is 7%.2 This is similar to New Zealand data, where 8% of patients are 
readmitted with a primary diagnosis of AECOPD within 30 days of discharge, and 14% within 60 days (based on 
recent Wellington Regional Hospital audit data).9 
 
In preparation for a randomized controlled trial powered to detect change in readmission rates, this study will 
inform an appropriate myAIRVO 2 prescription for COPD patients, recruitment rate projection and aspects of the 
trial design that need to be changed to increase the quality of data collection and patient compliance. 
 
Should NHF therapy be demonstrated as an effective and well tolerated intervention to reduce hospital 
readmissions and improve symptoms following AECOPD, NHF therapy could be considered an effective and 
routine treatment option on discharge. 
7.3. 
Preclinical Testing 
Appropriate pre-clinical testing and data evaluation was carried out as a part of the product release for the 
AIRVO 2 series. The AIRVO 2 series is cleared for both hospital and home use by the FDA, and as this study 
only involves unmodified devices used as per intended use, further preclinical/safety testing is not required for 
this feasibility study. 
7.4. 
Previous Clinical Experience 
The AIRVO 2 series has been and is currently used for delivering NHF therapy to COPD patients, worldwide 
(including New Zealand and USA), in  health care and domiciliary settings since 2013. 

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7.5. 
Justification for Administration 
Participants will be asked to use myAIRVO 2, for participants on domiciliary oxygen, the oxygen will be 
delivered via the device (see section 9.10.04). Participants will not be given a specific time period to wear the 
device, but encouraged to use the therapy every day as much as possible without impacting on their daily 
routines. The first day after discharge will be classed as day one of the study. NHF therapy will be monitored 
from day one for a period of 30 days. 
 
For all participants NHF therapy will be initiated at 25L/min with a the temperature setting of 37°C. All 
participants have the ability to reduce the temperature setting to 34°C. In participants who are not prescribed 
oxygen there will be the further option to increase or decrease flow rates (up to 30L/min or down to 20L/min). 
These modifications are to assist with comfort and adherence. Patients who are prescribed domiciliary oxygen 
flow rates will remain constant to deliver a more consistent concentration of oxygen. 
  
The outcomes of this study will inform the appropriate methodology for subsequent randomized control trials to 
investigate the efficacy of NHF therapy in the long-term management of COPD patients. Given this, therapy 
settings, compliance to the therapy in this feasibility study are modifiable to gain maximum understanding of 
therapy usage. 
8. 
OBJECTIVES OF THE CLINICAL INVESTIGATION 
8.1. 
Hypothesis 
This is a feasibility study to assess the process, resources, management and scientific aspects of NHF therapy use 
following discharge from hospital post AECOPD. This will inform the randomized controlled trial  design to 
ensure methodological robustness.   
8.2. 
Objectives 
The objectives of the study: 
1. To estimate the duration of use of the device including the mean hours of use per day and number of days 
use, to inform an daily myAIRVO 2 prescription for the proposed randomized controlled trial 
2. To estimate the proportions of potential participants who could proceed to the proposed randomized 
controlled trial 
3. To estimate the proportions of potential participants who would require oxygen delivery through 
myAIRVO 2 in the proposed randomized controlled trial 
4. To estimate aspects of the use of myAIRVO 2 after discharge and to in particular estimate patient ratings 
of ease of use, and the proportion of those who required changes to initial settings of temperature and 
flow, and the magnitude of these changes, to inform prescription design for the proposed randomized 
controlled trial 
5. To estimate particular clinical outcomes relevant to the planned randomized controlled trial, including 
hospital readmission, Emergency Department (ED visit) and General Practitioner (GP) visit rates.  
8.3. 
Population 
One hundred patients admitted to hospital with an AECOPD. Participants will be recruited from two sites: 
Wellington Regional Hospital, New Zealand (20 participants) and Alana Healthcare, USA (80 participants). 
Please see section 9.8 for details of inclusion/exclusion criteria. 
8.4. 
Risks & Benefits 
NHF therapy delivered by myAIRVO 2 may provide direct benefit to patients recovering from AECOPD by 
providing overnight respiratory support, improvement in mucocilliary clearance7 and increased nasal temperature 
(to 37°C) which may reduce the incidence of subsequent infection.8  
 

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myAIRVO 2 operates according to the principle of all active respiratory gas humidifiers by artificially 
conditioning inspiratory airflow with heat and humidity. 
 
The risk of using an active humidifier are electric shocks, burns of the patient and tubing melt down. The risks 
stated above are associated with any medical device, which uses electrical power for heating/warming. These 
risks are minimized as myAIRVO 2 is CE marked and has FDA Premarket Approval (PMA) clearance. The use 
of the device is in accordance to the user instructions and participants will be instructed according to the user 
guide. 
 
The risks of NHF therapy for patients who receive supplemental oxygen are inappropriate oxygen delivery, with 
the potential for hyperoxemia, carbon dioxide retention, or hypoxemia. These risks will be minimized by an 
initial oxygen assessment by the study physician, comprehensive education for participants and exclusion of 
participants who the investigator is concerned may be at risk of giving themselves incorrect oxygen delivery.   
 
There is no contraindication known to the use of active humidifiers in patients. 
8.5. 
Essential Requirements of the Relevant Directive  
ICH GCP and Ethics Committee approval. 
9. 
CLINICAL INVESTIGATION DESIGN 
9.1. 
Type of Investigation 
Feasibility study. 
9.2. 
Controls 
There is no control group required for this study. 
9.3. 
Bias 
The feasibility study is designed to inform a future randomized controlled trial. Therefore bias is not relevant for 
the outcomes of this study. 
9.4. 
End Points 
The following end points will be evaluated: 
 
Primary outcome: 
The primary outcome will be NHF use for 30 days following discharge after AECOPD. Use will be expressed as 
hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring.  
 
Secondary outcomes: 
 
Other use variables: 
 
i. 
Number of days of use, adjusted for number of days with myAIRVO 2 at home 
ii. 
Average use per day of myAIRVO 2 during week 1, week 2, week 3 and week 4. 
iii. 
Average use per day on days of myAIRVO 2 use 
 
 
Withdrawals and exclusions: 
 
i. 
Proportion of participants screened that were excluded  
ii. 
Reason for exclusion 
iii. 
Proportion of participants enrolled that were withdrawn 
iv. 
Reason for withdrawal 
 

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Participants requiring oxygen delivery via myAIRVO 2: 
 
i. 
Proportion of participants using domiciliary oxygen 
 
 
Aspects of myAIRVO 2 use: 
 
i. 
Proportion of participants who reported having reduced myAIRVO 2 flow settings from the 
initial flow 
ii. 
Reduction in flow 
iii. 
Proportion of participants who reported having increased myAIRVO 2 flow settings from the 
initial flow 
iv. 
Increase in flow 
v. 
Proportion of participants who reported having reduced myAIRVO 2 temperature setting from 
the initial setting 
vi. 
NHF therapy Questionnaire results  
 
Clinical outcomes 
i. 
Proportion of participants with at least one hospital readmission within 30 days of discharge 
ii. 
Reasons for  hospital admissions (AECOPD, other respiratory cause or other cause) 
iii. 
In those that had at least one hospital readmission: 
a. Number of readmissions  
b. Time to first hospital readmission 
c. Hospital readmission length 
iv. 
Proportion of participants with at least one ED visit within 30 days of discharge 
v. 
Reason for  ED visits (AECOPD, other respiratory cause or other cause) 
vi. 
In those that had at least one ED visit: 
vii. 
Number of ED visits  
viii. 
Time to first ED visit 
ix. 
Proportion of participants with at least one GP visit within 30 days of discharge  
x. 
Reason for  GP visits (AECOPD, other respiratory cause or other cause) 
 
xi. 
In those that had at least 1 GP visit within 30 days of discharge: number of GP visits  
xii. 
LACE Index for hospital admissions 
xiii. 
Lung function measurements (FEV1, SVCin and FVC) at day 1 and 31. 
 
* An ED visit is counted if the patient went to ED for assessment and was not subsequently admitted to a  
hospital ward.  
9.5. 
Variables 
i. 
myAIRVO 2 electronic monitoring data (device usage) 
ii. 
Number of exclusions 
iii. 
Number of withdrawals  
iv. 
Domiciliary oxygen use 
v. 
Aspects of myAIRVO 2 use  
vi. 
Clinical outcomes 
9.6. 
Measurements 
i. 
myAIRVO 2 electronic monitoring 
ii. 
30 day NHF therapy Diary 
iii. 
NHF therapy Questionnaire 
iv. 
Recording of events: myAIRVO 2 use, exclusions, withdrawals, and clinical outcomes 
v. 
Spirometry  

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9.7. 
Equipment 
i. 
Case report forms and questionnaires will be in paper format.  
ii. 
Spirometry data will be collected using a handheld spirometer (Jaegar pneumotac spirometer 
with J-Lab software) 
iii. 
De-identified data  (Participant ID only) will be recorded on the CRFs will be scanned to Fisher 
and Paykel, who will then enter it onto a secure electronic study database.  
9.8. 
Inclusion / Exclusion criteria 
Participants will be 18 years of age or older  
Participants will be admitted to the respiratory ward(s) of either recruiting hospitals with AECOPD as the primary 
diagnostic reason for admission. They will be excluded if: 
 
i. 
They are given a new domiciliary oxygen prescription during the current hospital admission 
ii. 
The investigator believes the participant or their care giver will be unable to safely use myAIRVO 2 
device following discharge 
iii. 
They have any other condition which, at the investigator’s discretion, is believed may present a safety 
risk or impact the feasibility of the study or the study results 
  
9.9. 
Point of Enrolment 
Participants will be considered enrolled and part of the study population at the time the inclusion and exclusion 
criteria have been met on the first visit in hospital. This will be after the Consent Form has been signed by both 
the Participant and Study Investigator.  
 
9.10. Patient Procedure 
9.10.1. 
Flowchart 
The flowchart of the study is shown in Appendix 1.  
 
9.10.2. 
Interventions 
 
a. Participants will be split into 2 groups (those on a domiciliary oxygen prescription at the time of study entry 
and those who are not) with both groups receiving NHF therapy by myAIRVO 2. Participants will be encouraged 
to use myAIRVO 2 as much as possible (day and night) each day without impacting on daily living activities. 
Participants who are prescribed domiciliary oxygen will use NHF therapy via myAIRVO 2 with supplemental 
oxygen delivered via the device (section 9.10.04). 
 
b. Interventions will be initiated from the time the participant is enrolled in hospital, to aid familiarization and 
acclimatization, and used until 30 days following discharge. Note the day of discharge is defined as Day 0. 
 
c. By default, NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered 
temperature to 34°C. For participants without a domiciliary oxygen prescription they can also increase/decrease 
the flow rate (up to 30L/min or down to 20L/min). Participants who have domiciliary oxygen flow rates are fixed 
in order to deliver a more consistent concentration of oxygen to maintain oxygen saturation.  

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9.10.3. 
Pre-discharge assessments and training 
 
a. Participants will be approached at least one day prior to expected discharge to ensure familiarity with NHF 
therapy prior to discharge. Written informed consent will be obtained (see participant information sheets and 
consent forms).  
 
b. Demographic data collection will include: Date of birth, gender, year of COPD diagnosis, presence of alpha1 
antitrypsin deficiency, other respiratory conditions, current medications, pack year history (a pack year is defined 
as twenty cigarettes smoked every day for one year, for a calculator see http://smokingpackyears.com/), LACE 
index score and if domiciliary oxygen is prescribed. The Investigator will update the Medical History Log and 
Medication Log. The last recorded spirometric values in the participant’s clinical records will also be 
documented. 
  
c. Participant inclusion and exclusion criteria (Section 9.8) will be assessed, and ineligible patients excluded. 
 
d. Participants will be allocated a myAIRVO 2 device and the device serial number will be recorded. 
 
e. A training session on how to use myAIRVO 2 will be performed by the study investigator (Appendix 2). The 
participants’ next of kin will be encouraged to be present at this session. Familiarization and acclimatization to 
the device and the therapy will also be conducted prior to leaving the hospital. Where possible any issues 
regarding the device or therapy will be addressed prior to discharge. The participant will also be given the 
myAIRVO 2 user manual and ‘Quick guide sheet’ to read prior to the home visit and a phone number to contact 
the investigator with any questions during business hours.  
 
f. For participants on oxygen only: If possible, oxygen saturation testing on the participant’s usual home oxygen 
flow will take place during the hospital admission. The participant will be placed on their home oxygen 
prescription while sitting at rest for at least 5 minutes. Should the participant’s oxygen saturation levels on their 
prescribed oxygen be <88% or >95% they will be withdrawn from the study and referred for review of their home 
oxygen prescription. 
 
g. The investigator will confirm with the participant preferably on day of discharge, if they would still like to 
continue in the study. The Investigator will update the CRF, including the Medical Contact Log, Medical History 
Log, Medication Log and AE/SAE forms as required. The device plus consumables and any participant 
paperwork required for the study will be made available prior to discharge or taken to the patients home on the 
day of or day after being discharged from the hospital..  
 
9.10.4. 
Post-discharge methods 
 
a. A home visit will be made by an investigator on the day of or day after discharge. The investigator will: 
i. 
Ensure the equipment is set up correctly and reinforce the previous training on myAIRVO 2. 
(Appendix 1).  
ii. 
Check participants will have the myAIRVO 2 user manual and the ‘Patient summary sheet’ as an 
easy reference for device use.  
iii. 
Perform lung function tests using a spirometer (Jaegar pneumotac spirometer with J-Lab software) 
according to ATS/ERS Taskforce standards.10 11 Participants will not be required to withhold 
bronchodilator medication prior to testing. The drug, dose and time of the last administration prior to 
spirometry will be recorded. This will inform COPD severity of participants and baseline lung 
function measurements. 
 
b. Participants on domiciliary oxygen will have oxygen saturations recorded on simple nasal prongs according to 
their existing prescription. NHF therapy will then be initiated and oxygen will be titrated through myAIRVO 2 to 
determine the flow of oxygen delivery required to achieve the same oxygen saturation level  (Section 9.10.04). 
 

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c. myAIRVO 2 devices will electronically record data on the date and time the device was used. Should 
participants change the flow of their myAIRVO 2 device (participants without domiciliary oxygen only) or alter 
the temperature, they will be asked to document this in their diary.  
 
d. On the 3rd, 7th, 14th and 21st and 28th day post discharge the investigator will contact the participant by phone. 
Participants will be asked: 
i. 
If they are having any problems using myAIRVO 2.  
ii. 
If they have needed to return to the hospital, the reason and length of their hospital visit. 
These details will be checked against hospital records. In addition, they will be asked if they 
have needed to visit their GP or other allied health care practitioners and the reason. The 
Investigator will complete the CRF and the medical history log, concomitant medications 
log, medical contact log, adverse event/ serious adverse event forms as required. 
 
 
e. On the 31st day post discharge an investigator will perform a home visit or the participant will visit the study 
investigator at their clinic office.  
 
i. 
When the investigator contacts the participant on day 28th day post discharge they will  
confirm with the participant the home /office visit time on the 31st day post discharge and 
that their last period of myAIRVO 2 use is to commence on day 30 (the day before the 
home/office visit).  
ii. 
At the home/office visit the NHF therapy Questionnaire will be administered.  
iii. 
Participants will be asked whether they have had any hospital admissions and the length and 
cause for any admissions. These details will be checked against hospital inpatient records. In 
addition they will be asked if they have visited their GP or other allied health care 
practitioners. The Investigator will complete the CRF and the medical history log, 
concomitant medications log, medical contact log, adverse event/ serious adverse event 
forms as required. 
iv. 
Lung function will be performed using a spirometer (Jaegar pneumotac spirometer with J-
Lab software) according to ATS/ERS Taskforce standards.10 11 Participants will not be 
required to withhold bronchodilator medication prior to testing. The drug, dose and time of 
the last administration prior to spirometry will be recorded. This will inform if lung function 
has improved during the study. 
v. 
The myAIRVO 2 device and associated equipment will be collected from the participant.   
 
9.10.5. 
myAIRVO 2 domiciliary oxygen assessment and prescription 
 
a. The participant will have their prescribed domiciliary oxygen flow rate recorded. 
  
b. Oxygen saturation levels will be measured (Point A) by oximetry after at least 5 minutes at rest using standard 
nasal prongs with oxygen administered according to their prescription (Flow A). Should the participant’s oxygen 
saturation levels be <88% or >95% they will be withdrawn from the study and referred for review of their home 
oxygen prescription. 
 
c. NHF therapy will then be administered to the participant by myAIRVO 2 set at a flow rate of 25L/minute with 
supplemental oxygen delivered at Flow A for at least 5 minutes whilst the participant is at rest. Oxygen saturation 
levels will then be recorded. 
 
d. While myAIRVO 2 is delivering 25L/min flow, oxygen will be titrated via the device by 0.5L/min every 5 
minutes until the oxygen saturation levels measured at Point A (i.e. with the portable oximetry probe after sitting 
at rest for at least 5 minutes using standard nasal prongs with oxygen administered at Flow A) are equivalent. 
This flow rate will be used for supplemental oxygen delivered during NHF therapy via  myAIRVO 2 throughout 
the study period. 
 

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e. An explanation will be given to the participant in respect to the risks and symptoms of hyperoxia, hypoxia, and 
hypercapnea, how to use myAIRVO 2 with correct oxygen flow rates, and how to change the oxygen flow 
between myAIRVO 2 and their standard nasal prongs (if required). They will also be provided with  the “‘Quick 
guide sheet’ specific to patients on domiciliary oxygen. 
 
f. If there is any clinical concern, the participant will be withdrawn from the study at the Investigator’s discretion. 
This may include, but is not limited to, concern regarding ability to maintain oxygen saturations within a safe 
range, the participant’s ability to understand the risks and symptoms of hypercapnia and hypoxia, and the 
participant’s ability to administer oxygen safely within the prescribed regimen. 
 
9.10.6. 
Excluded participants 
All participant exclusions will be documented on the Participant eligibility_screening log 
9.10.7. 
Associated documents 
Documents associated with this methodology include: 
1. Consent form and participation information sheet for New Zealand participants 
2. Consent form and participant information sheet for USA participants 
3. Case report forms: 
a. CRF NZ 
b. CRF US 
c. Medical history log 
d. Concomitant medications log 
e. Adverse event (AE) form 
f. Serious adverse event (SAE) form 
g. Medical contact log 
4. NHF therapy diary oxygen 
5. NHF therapy diary no oxygen 
6. NHF therapy questionnaire 
7. Participant eligibility_screening log 
8. Participant enrolment_withdrawal log 
9. Fisher and Paykel myAIRVO 2 user manual   
10. Patient summary sheet oxygen NZ 
11. Patient summary sheet oxygen US 
12. Patient summary sheet no oxygen NZ 
13. Patient summary sheet no oxygen US 
14. Data collection SOP 
15. myAIRVO 2 electronic monitoring SOP 
16. Equipment provision SOP 
17. Equipment log 
18. LACE Index 
 
9.11. Withdrawal Criteria 
Participants are able to stop the intervention at any time, without being withdrawn from subsequent portions of 
the study. Participants may withdraw from the entire study at any time without giving a reason. Participants may 
be withdrawn at the discretion of the Investigator for any reason that is believed may present a safety risk.  
 
9.12. Number of Trial Subjects 
100 (20 from NZ and 80 from USA sites, respectively) subjects.  
9.13. Follow up Plan 
The device will be used for 30 days at home post discharge of AECOPD. Participant contact by phone will occur 
on the 3rd, 7th, 14th and 21st and 28th day post discharge to check whether the participant has any problems 

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using myAIRVO 2. At the end of the 30 days a further home visit or office visit (participant preference) will 
occur, a questionnaire will be administered and the device collected. Participants are also able to contact 
investigators during the study period by phone for assistance. When study visits and phone calls fall outside of 
the working week these should be rescheduled to take place +/- 1 day of the specified date.  
 
The level and duration of follow up should permit the demonstration of performance over a period of time 
sufficient to represent a realistic test of the protocol and the myAIRVO 2 device.  
 
9.14. Foreseeable Complications 
There are no foreseeable complications with recruitment or completion of the study in general. All units have 
already been prepared for trial. Complications relating to adherence to the study protocol and NHF therapy use 
are outcome measures of this study. 
 
10. 
CLINICAL TRIAL DOCUMENTATION 
10.1. Consent and Recruitment 
NZ specific and USA specific information sheets and consent forms are to be used, as approved by their local 
regulatory body. 
10.2. Case Report Forms 
The CRFs are to be filled in by hand, see Data Collection SOP. CRFs are to be scanned to Fisher and Paykel who 
will then entered data into an electronic database. 
 
10.3. 
Insurance Statement 
A copy of the insurance statement is shown in Appendix 3. This is to document that compensation to subjects(s) 
for trial related injury will be available 
10.4. 
Record of Deviations  
This version of the protocol has was completed prior to participant recruitment, there are no deviations to date. 
11. 
STATISTICAL CONSIDERATIONS 
11.1. 
Description of the Statistical Design 
As this is a feasibility study the primary outcome variable (9.4.1) will be expressed as the mean number of hours 
per day used, with standard deviation. The mean may be weighted for time in the study and allocated 95% 
confidence intervals for each by weighted regression. 
 
Continuous outcomes 9.4.2-4, 9.4.11, 9.4.13, 9.4.18c, and 9.4.26 will also be expressed as mean, standard 
deviation. Means may be weighted for time in the study and allocated 95% confidence intervals for each by 
weighted regression.  
 
For the mean number of hospital readmissions (9.4.18a), ED visits (9.4.21a) and GP visits (9.4.24) Poisson 
regression will be used.  
 
Time to first hospital readmission (9.4.18b) and first ED visit (9.4.21b) will be analyzed by Kaplan-Meier 
survival estimates and CI for quantiles of survival, those who don’t get admitted within the study time will be 
censored data. 
 
Categorical outcomes 9.4.5-10, 9.4.12, 9.4.14, 9.4.16, 9.4.17, 9.4.19, 9.4.20, 9.4.22, 9.4.23 and 9.4.25 will be 
described by absolute numbers and proportions. Confidence intervals may be calculated for outcomes 9.4.5-10, 
9.4.12, 9.4.14, 9.4.16, 9.4.19, and 9.4.22.  

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NHF questionnaire results (9.4.15) will likely be presented by mean, standard deviation and confidence interval, 
however if the data distribution is heavily skewed data may be presented as proportions.  
 
11.2. 
Sample Size 
The NZ site and USA site will recruit 20 and 80 patients, respectively. These values are based on an estimated 
drop-out rate of 20% and the requirement for a minimum of 80 patients in total to assess feasibility and provide 
robust information in respect of appropriate outcome measures.  
 
11.3. 
Pass/Fail Criteria 
There will be no pass/fail criteria as this is a feasibility study for evaluation of outcomes for subsequent trial 
design. 
11.4. 
Statistical Termination 
There will not be a statistical interim analysis. Therefore no criteria for termination on statistical grounds. 
11.5. 
Statistical Procedure Deviations 
Any deviation(s) from the original statistical plan will be described and justified in the protocol or final report, as 
appropriate. 
11.6. 
Selection Criteria 
For endpoint details see section 9.4. All participants who were screened to take part in the study will be included 
in the analysis of endpoint 2.b.i. All patients who were discharged with a myAIRVO 2 device to take home will 
be included in analysis of all other endpoints. 
11.7. 
Statistical Data Management 
As above. Data analysis will be with SAS 9.3 
12. 
ADVERSE EVENTS AND TERMINATION 
Fisher and Paykel Healthcare Data Safety Monitoring Board will review all SAE’s.  
12.1. 
Emergency Contact Details 
 
Contact details below are for Investigator’s to contact the Sponsor. SAEs will be reported to the Data Safety 
Monitoring Board within 24 hours:  
 
Name: Stanislav Tatkov 
Address: 15 Maurice Paykel Place, East Tamaki, Auckland 2013, NZ 
Email: stanislav.tatkov@fphcare.co.nz 
Phone: +64 9 574 0123  EXT 7938 
Professional Position: Clinical Research Manager, F&P Healthcare 
12.2. 
Foreseeable Adverse Events 
Participants may wish to discontinue NHF therapy should they find it uncomfortable. Adverse events are 
expected, including death, hospital and Intensive Care Unit admissions and patient deterioration as part of disease 
progression. 
12.3. 
Reporting Adverse Events 
For the purposes of this study the following events will be considered to be serious adverse events (SAEs): 
 Death 
 Life-threatening event 

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 Permanently disabling or incapacitating event 
 Hospitalisation or prolongation of hospitalisation.  Hospitalisation for the purposes of SAE reporting is 
defined as an admission to hospital and does not include a presentation to the ED followed by discharge 
without admission or an admission for elective reasons  
 Any event considered serious by the study investigator 
 
SAEs will be reported to the Sponsor (Fisher and Paykel Healthcare) within 24 hours of the investigator 
becoming aware of the event on the study SAE form. Other adverse events will also be reported to the Sponsor 
within seven days.  
 
Other adverse events (AEs) will be reported to the Sponsor (Fisher and Paykel Healthcare) within 7 days of the 
investigator becoming aware of the event on the study AE form. 
 
Device deficiencies (related to the identity, quality, durability, reliability, safety or performance of a device) will 
be reported to the Sponsor (Fisher and Paykel Healthcare) in writing. If the investigator deems the event could 
have led to a serious adverse event, it must be reported within 24 hours of the investigator becoming aware it, 
otherwise it should be reported within 7 days. The sponsor will manage device deficiency reports as part of its 
ongoing post marketing safety review process and the investigator will supply the sponsor with additional safety 
information as required. 
 
Adverse events and device deficiencies will be reported to the HDEC, IRB, Medsafe and FDA as required 
 
12.4. Early Termination 
Early termination may occur at the discretion of the Investigators for any reason that is believed may present a 
safety risk. 
 
The following documentation is required if the appropriate party terminates a clinical trial. 
12.4.1. 
Investigator 
If the investigator terminates or suspends a trial without prior agreement of the Sponsor, the investigator should 
inform the institution, where required by the applicable regulatory requirements and the investigator/institution 
should promptly inform the sponsor and the IRB/IEC, and should provide the sponsor and the IRB/IEC a detailed 
written explanation for the termination or suspension.  
12.4.2. 
Sponsor 
If the Sponsor terminates or suspends a trial, the Sponsor should promptly inform the investigator. The 
investigator should then promptly inform the IRB/IEC and provide the IRB/IEC a detailed written explanation for 
the termination or suspension. 
12.4.3. 
Institutional Review Board (IRB) or Independent Ethics Committee (IEC)  
If the IRB/IEC terminates or suspends its approval/favorable opinion of a trial the investigator should inform the 
institution, where required by the applicable regulatory requirements, and the investigator/institution should 
promptly notify the sponsor and provide the sponsor with a detailed written explanation for the termination or 
suspension. 
13. 
PUBLICATION POLICY 
The study sites, represented by the principal investigator (PI), will take responsibility to report the results in an 
appropriate scientific venue. Publication of the study outcomes will comprise the study as a whole and is 
encouraged by the sponsor regardless of outcome. The sponsor retains editorial rights to protect the sponsor’s 
proprietary information and intellectual property.  
14. 
APPROVAL  
Signing the below approval indicates that the principle investigator(s) (PI) in each trial center and the sponsor 
agree to this version of Clinical Investigator Plan. 

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Primary Investigator Approval:  
 
PI Name:  
 
 
 
 
_______________________________________ 
 
PI Signature:   
 
 
 
_______________________________________ 
Date (dd/mmm/yyyy):   
 
 
_______________________________________ 
 
Sponsor Approval  
 
Sponsor Name:  
 
 
 
_______________________________________ 
 
Sponsor Signature:  
 
 
 
_______________________________________ 
Date (dd/mmm/yyyy):   
 
 
_______________________________________ 
 
 

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15. 
REFERENCES 
1. Martin P, Glasgow H, Patterson J. Chronic obstructive pulmonary disease (COPD): smoking remains 
the most important cause. N Z Med J 2005;118(1213):U1409. 
2. Elixhauser A, Au DH, Podulka J. Readmissions for Chronic Obstructive Pulmonary Disease, 2008: 
Statistical Brief #121. 2006. 
3. Garcia-Aymerich J, Farrero E, Felez MA, Izquierdo J, Marrades RM, Anto JM. Risk factors of 
readmission to hospital for a COPD exacerbation: a prospective study. Thorax 2003;58(2):100-5. 
4. Price LC, Lowe D, Hosker HS, Anstey K, Pearson MG, Roberts CM. UK National COPD Audit 2003: 
Impact of hospital resources and organisation of care on patient outcome following admission for acute 
COPD exacerbation. Thorax 2006;61(10):837-42. 
5. Wong AW, Gan WQ, Burns J, Sin DD, van Eeden SF. Acute exacerbation of chronic obstructive 
pulmonary disease: influence of social factors in determining length of hospital stay and readmission 
rates. Can Respir J 2008;15(7):361-4. 
6. Rea H, McAuley S, Jayaram L, Garrett J, Hockey H, Storey L, et al. The clinical utility of long-term 
humidification therapy in chronic airway disease. Respir Med 2010;104(4):525-33. 
7. Gotera C, Diaz Lobato S, Pinto T, Winck JC. Clinical evidence on high flow oxygen therapy and 
active humidification in adults. Rev Port Pneumol 2013;19(5):217-27. 
8. Singh M. Heated, humidified air for the common cold. Cochrane Database Syst Rev 
2011(5):CD001728. 
9. Pilcher J, Cameron L, Braithwaite I, Bowles D, Swain A, Bailey M, et al. Comparative audit of oxygen 
use in the prehospital setting, in acute COPD exacerbation, over 5 years. Emerg Med J, emermed-2013-
203094, Published Online First 2013. 
10. Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, et al. General considerations 
for lung function testing. Eur Respir J 2005;26(1):153-61. 
11. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, et al. Standardisation of 
spirometry. Eur Respir J 2005;26(2):319-38. 
 
 

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16. 
APPENDIX 1: FLOWCHART  
 
 
 
 

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17. 
APPENDIX 2: TRAINING SESSION REQUIREMENTS 
 
Hospital Acclimatization/Familiarization session  
 
Instruction 
myAIRVO 2 manual reference 
 
 
Familiarize and acclimatize participant to NHF therapy 
using myAIRVO 2, this should include a period of 
NHF use by the participant. 
 
N/A 
Explain warnings on page A-2 of myAIRVO 2 
 
A-2 
Explain how myAIRVO 2 works and what each of the 
consumables are for 
 
A-3 
Demonstrate switch on and startup of myAIRVO 2 and 
document participant’s nasal cannula size (small, 
medium or large)  
 
A-7 
Instruct participant to change temperature setting and 
NOT activate junior mode  
 
 
A-8 to A-9 
Participants NOT on domiciliary oxygen: Demonstrate 
how to change target flow  
OR 
Participants on domiciliary oxygen only: Demonstrate 
how to connect oxygen tubing, explaining warnings for 
oxygen use  & instruct participant NOT to change 
myAIRVO 2 flow setting 
A-8 
 
 
A-10 
Demonstrate how to put myAIRVO on night mode 
 
A-9 
Give participant myAIRVO 2 manual and ’Quick 
guide’ sheet 
N/A 
 
 
 

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Full training Session at home visit: 
 
 
Instruction 
myAIRVO 2 manual reference 
Explain warnings on page A-2 of myAIRVO 2 
 
A-2 
Re-explain how myAIRVO 2 works and what each of 
the consumables are for 
 
 
 
 
A-3 
Demonstrate startup of myAIRVO 2 including: 
- 
Position of AIRVO 
- 
Water chamber instillation, and that distilled 
water must be used 
- 
How to check water level and to avoid letting 
water run out 
- 
Installation of heated breathing tube 
 
 
A-4 to A-6 
Demonstrate how to switch on myAIRVO 2 
including: 
- 
Switch on 
- 
Warm up screen 
- 
Connection of patient interface 
 
 
A-7 
Explain the drying mode and that should the 
participant wish to use myAIRVO 2 while it is in 
drying mode they can override it by pressing the main 
button twice or switching it off then on at the wall. 
 
A-7 
Participants NOT on domiciliary oxygen: 
Demonstrate how to change target flow  
OR 
Participants on domiciliary oxygen only: 
Demonstrate how to connect oxygen tubing, 
explaining warnings for oxygen use  & instruct 
participant NOT to change MyAIRVO 2 flow setting 
 
A-8 
 
 
A-10 
Instruct participant NOT to activate junior mode  
 
 
A-8 to A-9 
Demonstrate how to put myAIRVO 2 on night mode 
 
A-9 
Show participant where the alarms section is in the 
manual is and advise to: 
- 
Consider contact with investigator if the 
A-11 to A-12 

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alarm sounds.   
- 
Contact with investigator MUST take place if 
the “Fault (E###) message is displayed 
 
Explain daily and weekly cleaning and maintenance 
regimens 
 
A-13 
Explain that there is a spare set of cannulas available 
should the participant soil theirs, and to contact the 
Investigator if more cannulas are needed 
A-14 
Instruct that the Filter in new and must NOT be 
removed, tampered with or replaced. 
A-14 
Ensure participant still has the ‘Quick guide’ sheet at 
front of myAIRVO 2 manual and reiterate that: 
 
- 
Participants can call during business hours 
with questions 
- 
myAIRVO 2 does NOT provide life support 
and should NOT be used to treat worsening 
symptoms, participant’s should instead seek 
medical help 
- 
If unsure, do not use myAIRVO 2 until 
contact has been made with one of the 
Investigators 
- 
myAIRVO 2 should NOT be left running 
when not in use. The only exception to this is 
if the participant removes it for a very short 
period of time (e.g. to go to the bathroom or 
make a drink) 
 
N/A 

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18. 
APPENDIX 3: INSURANCE CERTIFICATE