fluticasone furoate/umeclidinium/vilanterol vs Ipratropium

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.

NCT06074185 · Phase 2 · completed

The study was not randomized or blinded and compared patients treated before and after implementation of the bundle rather than using a concurrent controlled trial; the intervention also included dexamethasone and a checklist, so the effect cannot be attributed to ipratropium alone. Although hospital admission is a clinical endpoint, the primary comparison was based on a small and internally inconsistent set of reported participants, with no reported significance analysis, so the result is unclear.