PMID- 32113924 OWN - NLM STAT- MEDLINE DCOM- 20210521 LR - 20210521 IS - 1931-3543 (Electronic) IS - 0012-3692 (Linking) VI - 158 IP - 1 DP - 2020 Jul TI - Ambulatory Oxygen in Fibrotic Interstitial Lung Disease: A Pilot, Randomized, Triple-Blinded, Sham-Controlled Trial. PG - 234-244 LID - S0012-3692(20)30343-3 [pii] LID - 10.1016/j.chest.2020.01.049 [doi] AB - BACKGROUND: 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. 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. TRIAL REGISTRY: Australian New Zealand Clinical Trials Registry; No.: ACTRN12617000054314; URL: www.anzctr.org.au/. CI - Copyright (c) 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved. FAU - Khor, Yet H AU - Khor YH AD - 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. FAU - Holland, Anne E AU - Holland AE AD - Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; Department of Physiotherapy, Alfred Health and Monash University, Melbourne, Australia. FAU - Goh, Nicole S L AU - Goh NSL AD - Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia; Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia. FAU - Miller, Belinda R AU - Miller BR AD - Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Australia. FAU - Vlahos, Ross AU - Vlahos R AD - School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia. FAU - Bozinovski, Steven AU - Bozinovski S AD - School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia. FAU - Lahham, Aroub AU - Lahham A AD - Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia. FAU - Glaspole, Ian AU - Glaspole I AD - Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Australia. FAU - McDonald, Christine F AU - McDonald CF AD - 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. LA - eng SI - ANZCTR/ACTRN12617000054314 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200228 PL - United States TA - Chest JT - Chest JID - 0231335 SB - IM MH - Aged MH - Aged, 80 and over MH - Australia MH - Exercise Tolerance MH - Feasibility Studies MH - Female MH - Humans MH - Lung Diseases, Interstitial/complications/physiopathology/*rehabilitation MH - Male MH - Middle Aged MH - Oxygen Inhalation Therapy/*instrumentation MH - Pilot Projects MH - Pulmonary Fibrosis/complications/physiopathology/*rehabilitation MH - Treatment Outcome MH - Walk Test OTO - NOTNLM OT - exertional hypoxemia OT - idiopathic pulmonary fibrosis OT - interstitial lung disease OT - oxygen OT - pulmonary fibrosis EDAT- 2020/03/03 06:00 MHDA- 2021/05/22 06:00 CRDT- 2020/03/02 06:00 PHST- 2019/07/26 00:00 [received] PHST- 2020/01/08 00:00 [revised] PHST- 2020/01/10 00:00 [accepted] PHST- 2020/03/03 06:00 [pubmed] PHST- 2021/05/22 06:00 [medline] PHST- 2020/03/02 06:00 [entrez] AID - S0012-3692(20)30343-3 [pii] AID - 10.1016/j.chest.2020.01.049 [doi] PST - ppublish SO - Chest. 2020 Jul;158(1):234-244. doi: 10.1016/j.chest.2020.01.049. Epub 2020 Feb 28.