At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Aclidinium bromide/formoterol Fixed-Dose Combination, Aclidinium bromide, and 2 other interventions for COPD. Completed, enrolled 1,625 participants across 74 sites in 5 countries.
Detailed Summary
This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine 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).
Study Details
Timeline
Interventions
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair
Inhaled Aclidinium bromide 400 μg, twice per day via Genuair
Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler
Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler