According to study results published in CHEST, it is feasible to conduct a randomized, triple-blinded, sham-controlled trial of ambulatory oxygen delivered via portable oxygen concentrator (POC) to evaluate its effects in patients with interstitial lung disease (ILD).
Exertional desaturation is common in patients with ILD and ambulatory oxygen therapy (AOT) is frequently prescribed despite a lack of data on its clinical benefits. POCs are an alternative source of AOT, which are rechargeable, more ergonomically designed, and preferred by patients.
Researchers conducted a pilot study (Australian New Zealand Clinical Trials Registry No.: ACTRN12617000054314) to explore the feasibility of conducting an adequately powered, randomized, triple-blinded, sham-controlled trial examining the efficacy of AOT delivered via POC in 30 patients with ILD and isolated exertional desaturation to <90% on 6-minute walk distance (6MWD) tests. Patients were randomly assigned to either 12-week ambulatory oxygen (active) or air (sham) delivered via portable concentrators, with assessments performed at baseline and weeks 4, 12, and 18.
While the researchers found no significant difference in 6MWD between groups at week 12 (P =.34), the oxygen group had a significantly higher Leicester Cough Questionnaire psychological domain score compared with the sham group, indicating better cough-related quality of life (P =.01) but a shorter duration of moderate to vigorous activities (P =.04). To adequately evaluate the therapeutic effects of AOT on daily activities, a longer duration of ≥6 months is necessary in future randomized controlled trials.
“In conclusion, this study provided feasibility data for conducting a randomized controlled trial with blinding of participants, assessors, and investigators to evaluate the use of AOT in patients with ILD,” the researchers wrote. “To clarify any therapeutic effects of POC on clinically meaningful outcomes, a definitive randomized controlled trial of AOT in patients with ILD is currently underway (ClinicalTrials.gov Identifier: NCT03737409).”
Disclosure: This clinical trial was supported by research grants from Austin Medical Research Foundation, Boehringer Ingelheim, Institute for Breathing and Sleep, Lung Foundation Australia (Ivan Cash Grantin-Aid for Idiopathic Pulmonary Fibrosis Research), and Sir Edward Dunlop Medical Research Foundation. Air Liquide Healthcare provided loan portable oxygen concentrators, nasal cannulas, and servicing of the concentrators without charge. Please see the original reference for a full list of authors’ disclosures.
Khor YH, Holland AE, Goh NSL, et al. Ambulatory oxygen in fibrotic interstitial lung disease. A pilot, randomized, triple-blinded, sham-controlled trial. CHEST. 2020;158(1):234-244.