The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.
Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.
Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.
Forest Investigative Site 0909
Glendale, Arizona, United States
Forest Investigative Site 2050
Pheonix, Arizona, United States
Forest Investigative Site 2029
Rancho Mirage, California, United States
Forest Investigative Site 1084
Stockton, California, United States
Forest Investigative Site 2045
Wheat Ridge, Colorado, United States
Forest Investigative Site 1152
Clearwater, Florida, United States
Forest Investigative Site 2053
Tampa, Florida, United States
Forest Investigative Site 2047
Tampa, Florida, United States
Forest Investigative Site 1431
North Dartmouth, Massachusetts, United States
Forest Investigative Site 2084
Summit, New Jersey, United States
...and 10 more locations
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)
Time frame: 0 to 12 hours post-dose on Day 14
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Time frame: Day 14
Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)
Time frame: Day 14
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