Beclomethasone (QVAR) vs fluticasone furoate/umeclidinium/vilanterol

NCT00109668 · Phase 3 · completed

This was a randomized, double-blind, placebo-controlled trial with over 400 patients, which gives it solid design fundamentals. However, no results have been posted, and the record does not state what the primary outcome measure actually was, so the strength of the eventual evidence cannot yet be confirmed.

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.