NCT06053164|RecruitingPhase 2DMC
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Sponsor study identifier
interventional
60
1 country
1
Study Start
July 1, 2025
Actual (reported)Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The investigators plan to conduct a study to find out if giving portable oxygen therapy (during physical activity) to patients with interstitial lung disease will improve quality of life, exercise tolerance, shortness of breath, and blood vessel function. Oxygen will be provided for a period of 8 weeks. Additionally, the investigators plan to investigate if it is helpful to deliver individualized support when providing oxygen therapy, through check-in phone calls with a respiratory therapist and by providing additional educational material.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2023
Actual (reported)September 25, 2023
Actual (reported)July 1, 2025
Actual (reported)March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Feasibility of investigation
Number of patients recruited and completing the protocol in each arm
2 years
Exercise tolerance
6 minute walk distance
Before and immediately after the intervention
Health Related Quality of Life, (EuroQol-5 Dimension-5 Level; EQ-5D-5L)
Questionnaire for Health-Related Quality of Life. Possible Range = 5-25; 5 = 11111 (no problems on any dimension); 25 = 55555 (extreme problems on all dimensions)
Before and immediately after the intervention
Health Related Quality of Life, (King's Brief Interstitial Lung Disease Questionnaire; KBILD)
Health status questionnaire. Domain and total score ranges are 0-100; 100 represents best health status
Before and immediately after the intervention
Dyspnea (Dyspnea-12 Questionnaire)
Before and immediately after the intervention
Vascular function
Before and immediately after the intervention
Cough (Leicester cough questionnaire; LCQ)
Before and immediately after the intervention
Pulmonary Artery Pressure
Before and immediately after the intervention
Cardiac Output
Before and immediately after the intervention
8 weeks of usual care with no supplemental oxygen provided
8 weeks of portable oxygen use (from a concentrator) during exertion
8 weeks of portable oxygen use (from a concentrator) during exertion, plus additional phone calls with a respiratory educator and educational material
Use of a portable oxygen concentrator for exertional activities lasting \>2 minutes
Clinical Physiology Laboratory
Edmonton, Alberta, T6G2R3, Canada
Khor YH, Holland AE, Goh NSL, Miller BR, Vlahos R, Bozinovski S, Lahham A, Glaspole I, McDonald CF. Ambulatory Oxygen in Fibrotic Interstitial Lung Disease: A Pilot, Randomized, Triple-Blinded, Sham-Controlled Trial. Chest. 2020 Jul;158(1):234-244. doi: 10.1016/j.chest.2020.01.049. Epub 2020 Feb 28.
Johannson KA, Pendharkar SR, Mathison K, Fell CD, Guenette JA, Kalluri M, Kolb M, Ryerson CJ. Supplemental Oxygen in Interstitial Lung Disease: An Art in Need of Science. Ann Am Thorac Soc. 2017 Sep;14(9):1373-1377. doi: 10.1513/AnnalsATS.201702-137OI.
Mike Stickland
University of Alberta
First Submitted
August 3, 2023
First Posted
September 25, 2023
Study Start
July 1, 2025
Actual (reported)Palliation of Dyspnea and Cough using Morphine in patients with Fibrotic Interstitial Lung Disease
Participants will receive disease-specific educational material (Living Well with Pulmonary Fibrosis: Oxygen), and will have scheduled phone appointments with a certified respiratory educator after 1, 3, and 5 weeks of oxygen therapy in order to address individual barriers to oxygen use and facilitate the optimal use of portable oxygen.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Visca D, Mori L, Tsipouri V, Fleming S, Firouzi A, Bonini M, Pavitt MJ, Alfieri V, Canu S, Bonifazi M, Boccabella C, De Lauretis A, Stock CJW, Saunders P, Montgomery A, Hogben C, Stockford A, Pittet M, Brown J, Chua F, George PM, Molyneaux PL, Margaritopoulos GA, Kokosi M, Kouranos V, Russell AM, Birring SS, Chetta A, Maher TM, Cullinan P, Hopkinson NS, Banya W, Whitty JA, Adamali H, Spencer LG, Farquhar M, Sestini P, Wells AU, Renzoni EA. Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):759-770. doi: 10.1016/S2213-2600(18)30289-3. Epub 2018 Aug 28.
Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 23, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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