At a glance
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A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating Aclidinium bromide for Chronic Obstructive Pulmonary Disease. Completed, enrolled 291 participants across 83 sites in 2 countries.
Detailed Summary
The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.
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