Khor, YH and Holland, AE and Goh, NSL and Miller, BR and Vlahos, R and Bozinovski, S and Lahham, A and Glaspole, I and McDonald, CF, Ambulatory oxygen in fibrotic interstitial lung disease: a pilot, randomized, triple-blinded, sham-controlled trial, Chest, 158, (1) pp. 234-244. ISSN 0012-3692 (2020) [Refereed Article]
Copyright 2020 American College of Chest Physicians
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.
|Item Type:||Refereed Article|
|Keywords:||exertional hypoxemia, idiopathic pulmonary fibrosis, interstitial lung disease, oxygen, pulmonary fibrosis|
|Research Division:||Biomedical and Clinical Sciences|
|Research Group:||Cardiovascular medicine and haematology|
|Research Field:||Respiratory diseases|
|Objective Group:||Clinical health|
|Objective Field:||Clinical health not elsewhere classified|
|UTAS Author:||Lahham, A (Dr Aroub Lahham)|
|Web of Science® Times Cited:||7|
|Deposited By:||Menzies Institute for Medical Research|
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