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Ambulatory oxygen in fibrotic interstitial lung disease: a pilot, randomized, triple-blinded, sham-controlled trial
Research question: Is it feasible to conduct a clinical trial of ambulatory oxygen delivered via portable concentrators in patients with ILD?
Study design and methods: In this randomized, triple-blinded, sham-controlled trial, 30 participants with ILD and isolated exertional desaturation to < 90% on 6-minute walk tests were randomized to 12-week ambulatory oxygen or air delivered via portable concentrators, with assessments performed at baseline and weeks 4, 12, and 18. Primary outcomes were trial feasibility and the change in 6-minute walk distance (6MWD) on room air at week 12.
Results: Study recruitment was completed within 18 months, with six withdrawals. Participant blinding was successful, with the Bang's Blinding Index being 0 (95% CI, -0.40 to 0.40) for the oxygen group and 0 (95% CI, -0.42 to 0.42) for the sham group. No significant difference in 6MWD was seen between groups at week 12 (mean difference of -34 m [95% CI, -105 to 36], P = .34). For secondary outcomes, compared with the sham group, the oxygen group had a significantly higher Leicester Cough Questionnaire psychological domain score, indicating better cough-related quality of life (mean difference of 0.9 [95% CI, 0.2 to 1.6], P = .01), but a shorter duration of moderate-to-vigorous activities (mean difference of -135 [95% CI, -267 to -3], P = .04) at week 12.
Interpretation: Based on the results of this pilot study, a definitive randomized controlled trial with a longer intervention duration is warranted to clarify therapeutic impacts of ambulatory oxygen in patients with ILD.
History
Publication title
ChestVolume
158Pagination
234-244ISSN
0012-3692Department/School
Menzies Institute for Medical ResearchPublisher
Amer Coll Chest PhysiciansPlace of publication
3300 Dundee Road, Northbrook, USA, Il, 60062-2348Rights statement
Copyright 2020 American College of Chest PhysiciansRepository Status
- Restricted