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The purpose of this study is to evaluate the efficacy, safety and tolerability 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 run-in period followed by a 12-week placebo-controlled lead-in treatment period. This will be followed by a 40-week treatment period and a 2-week follow up phone call. All patients from the placebo group will be randomized to one of two doses of aclidinium bromide from the 12-week placebo-controlled lead-in study.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Aclidinium bromide, Aclidinium bromide, Placebo
Forest Investigative Site 1493
Published on BioPortfolio: 2014-08-27T03:16:47-0400
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COPD (chronic obstructive pulmonary disease)
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