Study identifier:D6570C00002
ClinicalTrials.gov identifier:NCT03022097
EudraCT identifier:N/A
CTIS identifier:N/A
A 24-week Treatment, Randomised, Parallel-group, Double blinded, Double-Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium bromide/Formoterol fumarate compared with Individual Components and Placebo and Aclidinium bromide compared with Placebo when Administered to Patients with Stable Chronic Obstructive Pulmonary Disease.
COPD
Phase 3
No
Aclidinium bromide/formoterol Fixed-Dose Combination, Aclidinium bromide, Formoterol Fumarate, Placebo
All
1067
Interventional
40 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Experimental 1 Aclidinium bromide 400μg/Formoterol fumarate 12 μg | Drug: Aclidinium bromide/formoterol Fixed-Dose Combination Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair |
Experimental: Experimental 2 Aclidinium bromide 400 μg | Drug: Aclidinium bromide Inhaled Aclidinium bromide 400 μg, twice per day via Genuair |
Active Comparator: Comparator Formoterol fumarate 12 μg | Drug: Formoterol Fumarate Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler |
Placebo Comparator: Placebo Placebo | Drug: Placebo Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler |