A feasibility study of a randomised controlled trial of asthma-tailored pulmonary rehabilitation compared with usual care in adults with severe asthma.

Abstract Background Currently the acceptability and efficacy of pulmonary rehabilitation (PR) for adults with severe asthma is unknown. Objective We investigated the feasibility of performing a randomised controlled trial of asthma-tailored PR (AT-PR) versus usual care (UC). Methods Adults with severe asthma were recruited and randomised 2:1 to AT-PR:UC. The primary outcomes were recruitment, retention and serious adverse event rates (SAE). Secondary outcome measures included those for a future trial assessing the feasibility of collecting data. Assessments were performed at baseline, 12 weeks and nine months including measures of physical performance, health-related quality of life (HRQoL), and asthma control. A recruitment rate of 30% was estimated with 95%CI of ±7%, a retention rate of 75% ±14% if we recruited 40 patients to AT-PR, and a SAE rate of 2.5%. Results 61/238 (26%) eligible patients were recruited: 38 females, mean (SD) age 54 (13)years, BMI 32 (7)kg/m2, FEV1 1.9 (0.7)L, FEV1/FVC 69 (11)%. 51 were randomised to either AT-PR (n=34) or UC (n=17). The retention rates were AT-PR 62%,UC 53% with a SAE rate of 3.3% related to the study visits. Overall collection of the outcome measures was feasible. The results were suggestive of improvements in exercise performance, HRQoL and asthma control with AT-PR compared to UC. Conclusion Both recruitment and retention rates were within the a priori estimated 95%CI. Our results indicate AT-PR may be efficacious for adults with severe asthma but any future intervention and trial design would need further modifications to improve acceptability and retention rate.