fluticasone furoate/umeclidinium/vilanterol vs Ventolin

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.

NCT01076322 · Phase 3 · completed

The study randomized participants to treatment sequences and included Ventolin as the active comparator, but it was open-label and small, with an estimated 17 participants. Its primary endpoint, change in FEV1, is a clinical lung-function measure, but no results are posted to show whether the comparison was favorable for Ventolin or met its prespecified objective.