Asthma is a common respiratory condition characterized by the narrowing and swelling of airways in the lungs, resulting in the production of extra mucus. The ICS/LABA therapy is routinely given to asthma patients, but the condition in patients with moderate-severe asthma remains inadequately controlled. This study aims to compare the safety and efficacy of two inhaler therapies: fluticasone furoate-umeclidinium-vilanterol (FF/UMEC/VI) and fluticasone furoate-vilanterol) FF/VI) for inadequately controlled asthma.
This randomized, double-blind, phase 3A trial included a total of 2,439 patients with inadequately controlled asthma. The patients were randomly assigned in a 1:1:1:1 ratio to receive FF/VI (100/25 μg or 200/25 μg) or FF/UMEC/VI (100/31.25/25 μg, 100/62.5/25 μg, 200/31.25/25 μg, or 200/62.5/25 μg). The primary outcomes of the study were a change from baseline in FEV1 and annualized moderate/severe asthma exacerbation rate.
The least-squares improvement in FEV1 change from baseline was 119 mL for FF/UMEC/VI 100/62·5/25 μg vs. FF/VI 100/25 μg and 92 mL for 200/62·5/25 μg versus 200/25 μg. Non-significant reductions in moderate/severe exacerbating rates occurred in the FF/UMEC 62·5 μg/VI versus FF/VI analysis.
The research concluded that in patients with inadequately controlled asthma, FF/UMEC/VI improved lung function but did not significantly impact moderate/severe exacerbations when compared with FF/VI.