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Trial registered on ANZCTR


Registration number
ACTRN12617000054314
Ethics application status
Approved
Date submitted
28/11/2016
Date registered
11/01/2017
Date last updated
2/05/2019
Date data sharing statement initially provided
29/11/2018
Date results information initially provided
29/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Ambulatory oxygen in interstitial lung disease
Scientific title
A Randomized Controlled Trial of Ambulatory Oxygen versus Air via Portable Concentrator in Chronic Interstitial Lung Disease
Secondary ID [1] 290431 0
None
Universal Trial Number (UTN)
Trial acronym
PC-ILD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease 300781 0
Condition category
Condition code
Respiratory 300611 300611 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to have supplemental intranasal ambulatory oxygen via Inogen One G2 portable concentrator as the ambulatory oxygen therapy. They will be provided the device for use at home and in the community during exertion for 3 months. There is no specific prescription for the frequency or duration of use. Participants can use the device as much or as little as they choose, with the intention that they use it during periods of exertion. The portable oxygen concentrator will be administering at level 6 for all participants.
Therapy usage will be monitored using a 7-day usage diary prior to each visit and the number of operated hours of portable concentrators.

Intervention code [1] 296275 0
Treatment: Devices
Comparator / control treatment
Sham treatment: Supplemental intranasal ambulatory air via Inogen One G2 portable concentrator at setting of 6
Control group
Placebo

Outcomes
Primary outcome [1] 300025 0
Change in walk distance during 6-minute walk test from baseline
Timepoint [1] 300025 0
12 weeks post treatment commencement
Primary outcome [2] 300330 0
Feasibility of the study design: Number of potential participants screened
Timepoint [2] 300330 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Primary outcome [3] 300344 0
Feasibility of the study design: Number of potential participants meeting the inclusion criteria
Timepoint [3] 300344 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [1] 329736 0
Feasibility of the study design: Number of participants recruited (Primary Outcome)
Timepoint [1] 329736 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [2] 329737 0
Feasibility of the study design: Number of participants randomised (Primary Outcome)
Timepoint [2] 329737 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [3] 329739 0
Feasibility of the study design: Number of participants withdrawn and reasons (Primary Outcome)
Timepoint [3] 329739 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [4] 329740 0
Feasibility of the study design: Number of follow-up assessments completed (Primary Outcome)
Timepoint [4] 329740 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [5] 329742 0
Feasibility of the study design: Number of deviations from the protocol and reasons (Primary Outcome)
Timepoint [5] 329742 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [6] 329743 0
Feasibility of the study design: Number of participants with complete data for the primary clinical outcome of 6-minute walk test (Primary Outcome)
Timepoint [6] 329743 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [7] 329744 0
Feasibility of the study design: Success of blinding (Primary Outcome)
Timepoint [7] 329744 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [8] 329745 0
Change in walk distance during 6-minute walk test from baseline
Timepoint [8] 329745 0
4 weeks post treatment commencement
Secondary outcome [9] 329746 0
Change in physical activity level using Sensewear activity monitor from baseline
Timepoint [9] 329746 0
4 weeks and 12 weeks post treatment commencement
Secondary outcome [10] 329747 0
Therapy compliance measurement (using both self-reported diary and number of operated hours of portable concentrators)
Timepoint [10] 329747 0
4 weeks and 12 weeks post treatment commencement
Secondary outcome [11] 329748 0
Change in symptom from baseline: The University of California San Deigo Shortness of Breath Questionnaire
Timepoint [11] 329748 0
4 weeks and 12 weeks post treatment commencement
Secondary outcome [12] 329749 0
Change in symptom from baseline: St George's Respiratory Questionnaire
Timepoint [12] 329749 0
4 weeks and 12 weeks post treatment commencement
Secondary outcome [13] 329750 0
Change in symptom from baseline: Leicester Cough Questionnaire
Timepoint [13] 329750 0
4 weeks and 12 weeks post treatment commencement
Secondary outcome [14] 329751 0
Change in symptom from baseline: Hospital Anxiety and Depression Scale
Timepoint [14] 329751 0
4 weeks and 12 weeks post treatment commencement
Secondary outcome [15] 329752 0
Change in symptom from baseline: Fatigue Severity Score
Timepoint [15] 329752 0
4 weeks and 12 weeks post treatment commencement
Secondary outcome [16] 329753 0
Change in symptom from baseline: Modified Medical Research Council Dyspnoea Scale
Timepoint [16] 329753 0
4 weeks and 12 weeks post treatment commencement
Secondary outcome [17] 329754 0
Biomarker for assessment of systemic oxidative stress and inflammation: Serum thiobarbituric acid reactive substances
Timepoint [17] 329754 0
Baseline, 4 weeks, 12 weeks and 18 weeks post treatment commencement
Secondary outcome [18] 330286 0
Biomarker for assessment of systemic oxidative stress and inflammation: Serum xanthine oxidase
Timepoint [18] 330286 0
Baseline, 4 weeks, 12 weeks and 18 weeks post treatment commencement
Secondary outcome [19] 330287 0
Biomarker for assessment of systemic oxidative stress and inflammation: Serum CCL-18
Timepoint [19] 330287 0
Baseline, 4 weeks, 12 weeks and 18 weeks post treatment commencement
Secondary outcome [20] 330288 0
Biomarker for assessment of systemic oxidative stress and inflammation: Serum IL-6
Timepoint [20] 330288 0
Baseline, 4 weeks, 12 weeks and 18 weeks post treatment commencement
Secondary outcome [21] 330289 0
Feasibility of the study design: Number of participants in each group who would elect to continue using the portable concentrator at the trial completion
Timepoint [21] 330289 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [22] 330290 0
Feasibility of the study design: Number of participants in each group who would recommend participating in this trial to others in a similar situation to themselves.
Timepoint [22] 330290 0
1 year post recruitment commencement and the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [23] 342859 0
Biomarker for assessment of systemic oxidative stress and inflammation: Serum C-reactive protein
Timepoint [23] 342859 0
Baseline, 4 weeks, 12 weeks and 18 weeks post treatment commencement
Secondary outcome [24] 342860 0
Change in symptom from baseline: The University of Alabama at Birmingham Study of Aging Life-Space Assessment
Timepoint [24] 342860 0
4 weeks and 12 weeks post treatment commencement

Eligibility
Key inclusion criteria
* Able to give written informed consent
* Chronic interstitial lung disease of any aetiology
* Able to perform a 6-minute walk test
* Desaturates to < 90% on room air during the 6-minute walk test
* Modified Medical Research Council Dyspnoea Scale greater than or equal to 1
* Participated in pulmonary rehabilitation within the 12 months prior to enrolment or has declined the offer of participation in pulmonary rehabilitation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current domiciliary or ambulatory oxygen use
* Patients meeting criteria for long term oxygen therapy based on measured arterial partial pressure of oxygen (defined as stable daytime PaO2 less than or equal to 55 mmHg, or stable daytime PaO2 56-59 mmHg with evidence of hypoxic organ damage (including right heart failure, pulmonary hypertension or polycythaemia)
* Significant communication or locomotor difficulties
* Current smokers
* Patients with concurrent chronic obstructive pulmonary disease (FEV1/FVC <60% and elevated RV/TLC ratio)
* Unstable disease in the last 4 weeks before screening
* Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To detect a difference in 6MWD of 34 metres, which we have shown is the minimal important difference for 6MWD in our population of patients with ILD, 62 patients will be required. This is based on a standard deviation of the change of 47 metres with 80% power. For an assumed dropout rate of 15%, a total of 73 participants will be randomized in a 1:1 ratio to supplemental ambulatory oxygen or air delivered via portable concentrator.

Data analysis will be performed according to the intention-to-treat principle. Level of statistical significance will be set at p = 0.05. Demographic data will be compared using chi2 or t tests. Other outcome measures will be analysed using linear mixed models or repeated measures analysis of variance as appropriate. Variables selected a priori to identify subgroups which might benefit differentially from ambulatory oxygen will be the severity of ventilatory impairment based on lung function results, gender, and patients with IPF.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6996 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 6997 0
The Alfred - Prahran
Recruitment postcode(s) [1] 14726 0
3084 - Heidelberg
Recruitment postcode(s) [2] 14727 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 294835 0
Charities/Societies/Foundations
Name [1] 294835 0
Institute for Breathing and Sleep
Address [1] 294835 0
145 Studley Road, Heidelberg, 3084 VIC
Country [1] 294835 0
Australia
Funding source category [2] 295076 0
Hospital
Name [2] 295076 0
Austin Medical Research Foundation
Address [2] 295076 0
145 Studley Road, Heidelberg, 3084 VIC
Country [2] 295076 0
Australia
Funding source category [3] 298606 0
Charities/Societies/Foundations
Name [3] 298606 0
Lung Foundation Australia
Address [3] 298606 0
Level 2, 11 Finchley Street
Milton QLD 4006
Country [3] 298606 0
Australia
Funding source category [4] 298607 0
Commercial sector/Industry
Name [4] 298607 0
Boehringer Ingelheim
Address [4] 298607 0
78 Waterloo Road
North Ryde, NSW, 2113
Country [4] 298607 0
Australia
Funding source category [5] 302652 0
Charities/Societies/Foundations
Name [5] 302652 0
Sir Edward Dunlop Medical Research Foundation
Address [5] 302652 0
145 Studley Road, Heidelberg, Victoria 3084
Country [5] 302652 0
Australia
Funding source category [6] 302653 0
Commercial sector/Industry
Name [6] 302653 0
Air Liquide Healthcare
Address [6] 302653 0
Unit 5, 476 Gardeners Road, Alexandria, NSW 2015 - Australia
Country [6] 302653 0
Australia
Primary sponsor type
Individual
Name
Dr Yet Hong Khor
Address
Institute for Breathing and Sleep
Austin Health
145 Studley Road, Heidelberg, 3084 VIC
Country
Australia
Secondary sponsor category [1] 293888 0
None
Name [1] 293888 0
Address [1] 293888 0
Country [1] 293888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296221 0
Austin Human Research Ethics Committee
Ethics committee address [1] 296221 0
145 Studley Road, Heidelberg, 3084 VIC
Ethics committee country [1] 296221 0
Australia
Date submitted for ethics approval [1] 296221 0
06/04/2016
Approval date [1] 296221 0
09/06/2016
Ethics approval number [1] 296221 0
HREC/16/Austin/103

Summary
Brief summary
Interstitial lung disease (ILD) is a group of chronic lung diseases of different causes which lead to symptoms of breathlessness, fatigue, reduced exercise tolerance and poor quality of life. There are limited medical treatments available to date for the majority of patients with ILD. Although ambulatory oxygen is commonly prescribed for patients with ILD suffering significant breathlessness or low oxygen levels during exercise, its clinical benefits are uncertain. Potential adverse effects include increased systemic oxidative stress and the negative impact on patients’ mental well-being from such a burdensome treatment. In addition, the use of oxygen therapy has significant costs for both patients and the health care system.

Ambulatory oxygen is usually delivered using oxygen cylinders. Portability and comfort of oxygen cylinders are important factors which prevent patients from using ambulatory oxygen as prescribed. The new lightweight portable oxygen concentrator (POC) may be an attractive alternative to oxygen cylinders. This study aims to compare the effects of ambulatory oxygen with room air delivered via portable concentrator on health outcomes, including exercise capacity, symptoms, activity levels, systemic oxidative stress and inflammation, in patients with chronic ILD and low oxygen levels during exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70050 0
Dr Yet Hong Khor
Address 70050 0
Department of Respiratory and Sleep Medicine
Austin Health
145 Studley Road, Heidelberg, 3084 VIC
Country 70050 0
Australia
Phone 70050 0
+613 9496 3688
Fax 70050 0
+613 9496 5124
Email 70050 0
yethong.khor@austin.org.au
Contact person for public queries
Name 70051 0
Dr Yet Hong Khor
Address 70051 0
Department of Respiratory and Sleep Medicine
Austin Health
145 Studley Road, Heidelberg, 3084 VIC
Country 70051 0
Australia
Phone 70051 0
+613 9496 3688
Fax 70051 0
+613 9496 5124
Email 70051 0
yethong.khor@austin.org.au
Contact person for scientific queries
Name 70052 0
Dr Yet Hong Khor
Address 70052 0
Department of Respiratory and Sleep Medicine
Austin Health
145 Studley Road, Heidelberg, 3084 VIC
Country 70052 0
Australia
Phone 70052 0
+613 9496 3688
Fax 70052 0
+613 9496 5124
Email 70052 0
yethong.khor@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For privacy reason
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary