Olodaterol vs Umeclidinium/Vilanterol

NCT00782210 · Phase 3 · completed

This was a randomized, double-blind, placebo-controlled phase 3 trial in 624 patients with COPD comparing two doses of olodaterol (5 mcg and 10 mcg once daily) against placebo. Both pre-specified co-primary endpoints—FEV1 AUC 0-3h and trough FEV1 at 12 weeks—were met for both doses, with large, statistically significant differences versus placebo (p<0.0001 for all primary comparisons). The trial was adequately powered, used a regulator-accepted lung function endpoint for COPD, and the primary results were clearly positive.

NCT01777334 · Phase 3 · completed

The trial randomly assigned 905 participants and used double blinding with tiotropium as an active comparator. Its primary endpoint was the clinical lung-function measure trough FEV1, and the primary comparison significantly favored umeclidinium/vilanterol.

NCT00467740 · Phase 2 · completed

The study randomized 296 participants to placebo or one of four olodaterol doses, but the registry does not clearly report whether treatment assignment was blinded. Its primary outcome was a lung-function surrogate rather than a hard clinical outcome, and results were mixed across doses: only olodaterol 20 micrograms significantly improved trough FEV1 versus placebo at 4 weeks.

No graded featured trial for this indication yet; the grade above reflects that absence, not a judgment.