Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial
RCT (n=2439) found that in patients with inadequately controlled asthma despite being on ICS/LABA, adding UMEC improved lung function but did not lead to significant reduction in moderate and/or severe exacerbations.
Source:
The Lancet Respiratory Medicine
SPS commentary:
In the study, the least squares mean improvement in FEV 1 change from baseline for FF/UMEC/VI 100/62·5/25 μg versus FF/VI 100/25 μg was 110mL (p<0·0001) and for 200/62·5/25 μg versus 200/25 μg was 92 mL (49–135;p<0·0001).
According to a commentary, these findinds are consistent with two RCTs of the single-inhaler triple-therapy (beclomethasone/formoterol/glycopyrronium), which were of similar design. However, the lack of significant effect of UMEC on moderate or severe exacerbation rates, and no clinically relevant effect on measures of asthma control, health status, or rescue medication use, leads to uncertainty about its clinical importance.
The FDA has just approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older, based on a supplemental New Drug Application which included data from the CAPTAIN study.
In Feb 2020, the European Medicines Agency accepted a submission seeking approval of Trelegy Ellipta for the treatment of asthma in adults.