fluticasone furoate/umeclidinium/vilanterol vs Proventil

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.

NCT00577655 · Phase 3 · completed

The trial randomized 103 children to albuterol or placebo and masked participants, caregivers, investigators, and outcome assessors. Its primary measures were physiologic lung-function outcomes rather than hard clinical outcomes; the FEV1 comparison was statistically significant, while the PEF comparison was not significant at the prespecified threshold, so the findings were mixed.