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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
561
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
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Time frame: Change from Baseline to 12 weeks
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)
Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)
Time frame: Change from Baseline to 12 weeks
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