Head-to-head evidence
Aclidinium bromide vs Aclidinium bromide/formoterol fumarate
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: Muscarinic acetylcholine receptor (M3) · full Chronic Obstructive Pulmonary Disease pipeline
Aclidinium bromide · Tudorza Pressair
Marketed by Covis Pharma
NCT00363896 · Phase 3 · completed
The trial randomized 843 participants to double-blind aclidinium or placebo and used trough FEV1, an accepted clinical lung-function endpoint for COPD, as its primary outcome at 12 and 28 weeks. Aclidinium showed higher reported mean FEV1 values at both time points, but because statistical significance for the primary comparisons is not reported, the result is considered unclear rather than definitively met.
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).
The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: Aclidinium bromide's landscape · Aclidinium bromide/formoterol fumarate's landscape