The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of 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 double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
544
Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.
Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment
Forest Investigative Site 1493
Birmingham, Alabama, United States
Forest Investigative Site 1419
Birmingham, Alabama, United States
Forest Investigative Site 1413
Muscle Shoals, Alabama, United States
Forest Investigative Site 1353
Pell City, Alabama, United States
Forest Investigative Site 1379
Phoenix, Arizona, United States
Part A: Morning Predose (Trough) 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 (Week 0) to Week 12
Part B: Morning Predose (Trough) FEV1
Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)
Time frame: Change from baseline (Week 0) to 52 Weeks
Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)
Time frame: Change from baseline (Week 0) to Week 12
Part B: Peak FEV1
Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)
Time frame: Change from baseline (Week 0) to 52 Weeks
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Forest Investigative Site 2065
Fullerton, California, United States
Forest Investigative Site 1451
National City, California, United States
Forest Investigative Site 1388
Paramount, California, United States
Forest Investigative Site 1424
Rolling Hill Estates, California, United States
Forest Investigative Site 1427
Sacramento, California, United States
...and 102 more locations