drugset / Trial / NCT06053164
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Phase 2
Recruiting
60 enrolled
University of Alberta
Alberta Boehringer Ingelheim Collaboration · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2025-07-01
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
Publications
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxygen | Other / unclassified | — | — |