albuterol / budesonide vs fluticasone furoate/umeclidinium/vilanterol

NCT03769090 · Phase 3 · completed

Participants were randomized and quadruple-blinded across two budesonide/albuterol groups and an active albuterol comparator, with 3,132 randomized participants. The primary clinical endpoint was met for both doses: severe exacerbations occurred in 207/1,013 versus 266/1,014 participants for high-dose treatment (hazard ratio 0.733, p<0.001) and 241/1,054 versus 276/1,056 for low-dose treatment (hazard ratio 0.835, p=0.041).

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.