At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Aclidinium bromide and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 561 participants across 112 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.
Study Details
Timeline
Interventions
Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment
Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment
Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment