drugset / Trial / NCT00626522

Aclidinium/Formoterol Fixed Combination Dose Finding Study

NCT00626522 ↗

Phase 2 Completed 808 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials

Timeline

Start
2008-02
Primary completion
2008-11
Completion
2008-11

Outcome

Met primary endpoint

registry Aclidinium 200 μg / Formoterol 6 μg vs Placebo; p <0.0001; Least squares mean difference 0.206 (95% CI 0.131 to 0.280); ANCOVA NCT00626522 ↗

registry Aclidinium 200 μg / Formoterol 12 μg vs Placebo; p <0.0001; Least squares mean difference 0.254 (95% CI 0.180 to 0.329); ANCOVA NCT00626522 ↗

registry Aclidinium 200 μg / Formoterol 18 μg vs Placebo; p <0.0001; Least squares mean difference 0.265 (95% CI 0.191 to 0.340); ANCOVA NCT00626522 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aclidinium Unknown — Inhaled
Subject Formoterol Other / unclassified — Inhaled