A feasibility randomized controlled superiority trial of fluticasone-vilanterol once daily use for the treatment of mild asthma in adults

Abstract

Background: The objective of this pilot study is to assess feasibility (recruitment and retention rates) of conducting a definitive randomized controlled trial (RCT) to investigate the effectiveness of fluticasone-vilanterol (Long-acting beta agonist+ Inhaled corticosteroids; LABA+ICS) in the management of mild asthma in adults, compared with usual care. Methods: In this 8-month parallel two-arm pilot trial we randomly assigned 18 patients with mild asthma in a 1:1 ratio to the treatment (n=10) or usual care (n=8) arms. The treatment group received daily LABA+ICS therapy while the usual care group continued as required SABA or SABA+ICS combination. The main outcome measures were descriptors of study feasibility. Secondary outcomes were asthma control score, quality of life, and the number of asthma exacerbations.   Results: The baseline characteristics of participants did not differ significantly across the two arms at the start of the trial. Because of slow recruitment and limited funding, the study didn’t meet our recruitment target but did successfully meet our retention criteria. At 32 weeks, analysis indicated significant improvement in asthma control scores in the intervention arm (1.31 vs 2.91; 95% CI [0.72, 2.44]; P-value=0.003), but no significant differences were noted in quality-of-life scores (P-value=0.197). There were no significant differences in post-intervention asthma control mean score (P-value=0.361) or QoL mean score (P-value=0.337) between the two arms after adjustment for pre-intervention scores. Conclusions: This pilot RCT indicates that a definitive RCT is feasible in a primary health care setting. We recommend increasing the recruitment rate by relaxing eligibility criteria, extending the timeline, and increasing the number of sites for recruitment. ClincialTrials.gov registration: NCT04265105 (11/02/2020)