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Title: | Ambulatory oxygen in fibrotic ILD: a pilot, randomised, triple-blinded, sham-controlled trial. | Austin Authors: | Khor, Yet H ;Holland, Anne E ;Goh, Nicole S L ;Miller, Belinda R;Vlahos, Ross;Bozinovski, Steven;Lahham, Aroub;Glaspole, Ian;McDonald, Christine F | Affiliation: | Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia Department of Medicine, Monash University, Melbourne, Australia School of Medicine, University of Melbourne, Melbourne, Victoria, Australia Institute for Breathing and Sleep Department of Physiotherapy, Alfred Health and Monash University, Melbourne, Australia Respiratory and Sleep Medicine School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia |
Issue Date: | 27-Feb-2020 | Date: | 2020-02-27 | Publication information: | Chest 2020; online first: 27 February | Abstract: | Despite 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. In this randomised, triple-blinded, sham-controlled trial, 30 participants with ILD and isolated exertional desaturation to <90% on 6-minute walk tests were randomised 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. 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, 0.40) for the oxygen group and 0 (-0.42, 0.42) for the sham group. There was no significant difference in 6MWD between groups at Week 12 (mean difference of -34m [95% CI: -105, 36], p = 0.34). For secondary outcomes, compared to 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, 1.6], p = 0.01), but a shorter duration of moderate-to-vigorous activities (mean difference of -135 [95% CI: -267, -3], p = 0.04) at Week 12. Based on the results of this pilot study, a definitive randomised controlled trial with a longer intervention duration is warranted to clarify therapeutic impacts of ambulatory oxygen in patients with ILD. | URI: | https://ahro.austin.org.au/austinjspui/handle/1/22760 | DOI: | 10.1016/j.chest.2020.01.049 | ORCID: | 0000-0002-5434-9342 0000-0001-6481-3391 0000-0003-2065-4346 0000-0003-2061-845X |
Journal: | Chest | PubMed URL: | 32113924 | Type: | Journal Article |
Appears in Collections: | Journal articles |
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