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

Objectives Current international guidelines recommend using a combination of Long-Acting Beta-Agonists and Inhaled Corticosteroids (LABA+ICS) therapy for symptomatic mild asthma. However, this change has yet to be widely implemented in the Middle East. The objective of this pilot study is to assess the feasibility (recruitment and retention rates) of conducting a future definitive RCT to investigate the effectiveness of fluticasone-vilanterol (LABA+ICS) in the management of mild asthma in adults, compared with usual care. Design This 8-month parallel two-arm pilot trial took place in the Kingdom of Bahrain. 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 (recruitment and retention rates). We also compared unblinded outcome assessment of asthma control score, quality of life, and the number of asthma exacerbations experienced by patients in both arms. Results A total of 18 patients were recruited from a single primary healthcare center and randomized by remote web-based allocation into intervention (n=10) and usual care (n=8) groups. 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, the 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) compared to the baseline levels. 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 healthcare setting in Bahrain. In a definitive trial, we recommend increasing the recruitment rate by relaxing eligibility criteria, extending the timeline, and increasing the number of sites for recruitment. Additionally, outcomes of this pilot trial suggest that LABA+ICS is a feasible, acceptable, safe, and effective intervention for the management of mild asthma in a Middle Eastern context.SPSSFunding provided by: Royal College of Surgeons in IrelandCrossref Funder Registry ID: http://dx.doi.org/10.13039/100012921Award Number