fluticasone furoate/umeclidinium/vilanterol vs Salbutamol HFA-152a

NCT02924688 · Phase 3 · completed

This was a large (N=2,436) randomized, triple-blind, active-controlled Phase III trial comparing four fixed-dose combinations of fluticasone furoate/umeclidinium/vilanterol against two fluticasone furoate/vilanterol dual therapy controls in patients with inadequately controlled asthma. The primary endpoint, change from baseline in trough FEV1 at Week 24, was met for every pre-specified triple-therapy versus dual-therapy comparison, with all four least-squares mean differences favoring triple therapy and p<0.001. The combination of randomization, blinding, an active comparator, a large sample, a hard clinical endpoint, and a statistically significant primary result constitutes strong evidence.

NCT06261957 · Phase 3 · completed

The trial randomized 477 participants and used quadruple blinding with an active salbutamol comparator. Its primary clinical safety endpoint was the number of participants with adverse events, but results are not posted, so whether the primary comparison was favorable cannot be determined.