Randomised controlled, crossover trial to evaluate the effects of ambulatory oxygen on health status in patients with fibrotic lung disease

Breathlessness is a key determinant of Quality of life (QoL) in patients with fibrotic ILD. 6 minute walk test (6MWT) data indicates that a fall in oxygen saturation (SaO2) in ILD patients, can be corrected by supplemental O2. However, no prospective studies have assessed the impact of ambulatory O2 on QoL in patients with ILD. We report on a prospective, multi-centre trial (NCT02286063), investigating the effects of ambulatory O2 in fibrotic ILD patients. Design: a randomized, cross-over controlled trial evaluating QoL, breathlessness, and mobility during two weeks on ambulatory O2 compared to two weeks off O2 in 80 ILD patients. Inclusion: patients with SaO2 ≥ 94% at rest, on room air dropping to ≤88% on a 6MWT.Primary outcome: health status assessed by the King9s Brief Interstitial Lung Disease Questionnaire. Key secondary outcomes: change in breathlessness and QoL scores (SGRQ, UCSDSBQ, HDAS), activity measurements and, in a subset, qualitative interviews. Interim Data patients randomized n=52, male n=37, mean age (± SD) of 64.5±1.1 yrs, ex-smokers n=36, mean FVC 69.3±18.4 %, and mean DLCO 38.7±12.8 %. Diagnosis: IIP n=31, CTD-ILD n=8, fibrotic HP n=6, miscellaneous n=7. All 45 patients that completed study wereoffered the option of continuing ambulatory O2. Conclusion: To date 35/45 (77.8%) patients have opted to continue with ambulatory O2 post study completion, suggesting the majority perceive that oxygen is beneficial. The final results of this study are expected to influence future ILD-specific guidelines for the use of ambulatory O2.