Head-to-head evidence
Aclidinium bromide/formoterol fumarate vs Olodaterol
Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.
Chronic Obstructive Pulmonary Disease
Shared mechanism: Beta-2 adrenergic receptor · full Chronic Obstructive Pulmonary Disease pipeline
Aclidinium bromide/formoterol fumarate · Duaklir Pressair
Marketed by Covis Pharma
NCT01437397 · Phase 3 · completed
This was a large randomized, quadruple-blind, placebo- and active-controlled trial with 1,692 randomized participants, using the regulator-accepted clinical lung-function measure FEV1 as its primary endpoint. Results were mixed: the 400/12 μg combination significantly improved post-dose FEV1 versus aclidinium and trough FEV1 versus formoterol, whereas the 400/6 μg combination did not significantly improve trough FEV1 versus formoterol (p=0.133).
Olodaterol
Marketed by Boehringer Ingelheim
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.
The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: Aclidinium bromide/formoterol fumarate's landscape · Olodaterol's landscape