This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
156
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Inhaled formoterol fumarate 12 µg twice-daily (BID)
Inhaled placebo to formoterol fumarate once-daily in the evening
Change From Baseline in Weekly Average Nocturnal Symptom Scores
Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all
Time frame: Week 4 of treatment
Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores
Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon
Time frame: Week 4 of treatment
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Inhaled formoterol fumarate 12 μg once-daily in the evening
Forest Investigative Site
Tucson, Arizona, United States
Forest Investigative Site
Tucson, Arizona, United States
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Fullerton, California, United States
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Lakewood, California, United States
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Rancho Mirage, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Stockton, California, United States
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Wheat Ridge, Colorado, United States
...and 30 more locations