fluticasone furoate/umeclidinium/vilanterol vs salbutamol

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.

NCT03528577 · Phase 3 · completed

The study randomized 128 participants in a quadruple-blind, four-period crossover design with active and placebo comparators. However, its primary endpoint was a pharmacodynamic surrogate rather than a hard clinical outcome. Results were not posted at the time of grading; the key result shown was recorded subsequently from the registry record.