At a glance
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A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating Aclidinium Bromide 200 µg and Aclidinium Bromide 400 µg for Chronic Obstructive Pulmonary Disease. Completed, enrolled 605 participants across 113 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.
Study Details
Timeline
Interventions
aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment