The results of a pilot study have demonstrated feasibility of conducting a large clinical trial in patients with fibrotic interstitial lung disease (ILD) treated with ambulatory oxygen therapy delivered via a portable oxygen concentrator, according to an article published in CHEST.
Changes in 6-minute walk distance (6MWD) in patients with ILD and isolated exertional desaturation were measured from baseline and after 4, 12, and 18 weeks of receiving either ambulatory oxygen or air delivered via portable concentrators. Participants were randomly assigned to treatment groups. Symptoms and health-related quality of life were evaluated using the mMRC Dyspnoea Scale, the University of California, San Diego Shortness of Breath Questionnaire, the Leicester Cough Questionnaire, the Fatigue Severity Scale, the Hospital Anxiety and Depression Scale, and the St. George’s Respiratory Questionnaire.
Of the 667 patients whose medical records were screened for inclusion, 194 were eligible to participate. Of these 194 patients, 30 consented to the trial, were enrolled into the study, and underwent randomization. Recruitment rates varied between 0.9 and 1.5 per month depending on the location.
Blinding was successful, with only 9 of the 24 patients who completed the study correctly guessing their intervention allocation (oxygen group=5; sham group=4), with another 9 guessing incorrectly and 6 who were uncertain. In the other primary study outcome, there was no significant difference in 6WMD on room air at week 12 between treatment groups (mean difference, -34 m; 95% CI, -105 to 36 m; P <.34).
All of the study participants stated they had positive experiences and that they would recommend a trial to others with ILD. Participants were motivated by the idea of advancing knowledge about ILD management as well as learning more about their condition through trial participation. Of the 24 participants who completed the survey at week 18, 31% and 45% in the oxygen and sham groups, respectively, noted that they would like to continue using the device.
“This study provided feasibility data for conducting a randomised controlled trial with blinding of participants, assessors and investigators to evaluate the use of [ambulatory oxygen therapy] in patients with ILD,” the researchers wrote. “In order to clarify any therapeutic effects of [portable oxygen concentrators] on clinically meaningful outcomes, a definitive randomised controlled trial of [ambulatory oxygen therapy] in patients with interstitial lung disease is currently underway (ClinicalTrials.gov Identifier: NCT03737409).”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Khor YH, Holland AE, Goh NS, et al. Ambulatory oxygen in fibrotic ILD: a pilot, randomised, triple-blinded, sham-controlled trial [published February 27, 2020]. CHEST. doi: 10.1016/j.chest.2020.01.049