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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
605
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
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
Time frame: From baseline to 52 weeks
Change From Baseline in Peak FEV1
Change From Baseline in Peak FEV1 in liters at Week 52.
Time frame: 52 weeks
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