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Randomized Controlled Trial
Ambulatory oxygen in fibrotic ILD: a pilot, randomised, triple-blinded, sham-controlled trial.
- Yet H Khor, Anne E Holland, Goh Nicole S L NSL Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia; Institute for Breathing and Sleep, Heidelberg, Victoria, , Belinda R Miller, Ross Vlahos, Steven Bozinovski, Aroub Lahham, Ian Glaspole, and Christine F McDonald.
- Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia; Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; School of Medicine, University of Melbourne, Melbourne, Victoria, Australia; Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia. Electronic address: yethong.khor@austin.org.au.
- Chest. 2020 Jul 1; 158 (1): 234-244.
BackgroundDespite a lack of evidence, ambulatory oxygen therapy is frequently prescribed for patients with interstitial lung disease (ILD) and exertional desaturation. Patients often prefer portable oxygen concentrators to oxygen cylinders. This study aimed to examine the feasibility of conducting a clinical trial of ambulatory oxygen delivered via portable concentrators in patients with ILD.Research QuestionIs it feasible to conduct a clinical trial of ambulatory oxygen delivered via portable concentrators in patients with ILD?Study Design And MethodsIn 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.ResultsStudy 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.InterpretationBased 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.Trial RegistryAustralian New Zealand Clinical Trials Registry; No.: ACTRN12617000054314; URL: www.anzctr.org.au/.Copyright © 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
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