The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
57
carmoterol (CHF 4226) 2 μg once a day, in the morning (1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)
carmoterol (CHF 4226) 4 μg once a day, in the morning (1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)
placebo once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)
Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, United States
Pulmonary Associates, PA
Phoenix, Arizona, United States
FEV1 AUC0-24 standardized by time
Time frame: on Day 15 (after 14 days of dosing)
FEV1(L)
Time frame: 30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods
blood pressure
Time frame: at the beginning and end of each of the four 14-day treatment periods
heart rate
Time frame: at the beginning and end of each of the four 14-day treatment periods
FEV1 percent change
Time frame: 30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods
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Salmeterol 50 μg twice daily, in the morning and in the evening (1 blister of Serevent Diskus BID)
UCLA David Geffen School of Medicine
Los Angeles, California, United States
University Clinical Research - DeLand, LLC
DeLand, Florida, United States
Pulmonary Medicine and Critical Care
Austell, Georgia, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States
Commonwealth BioMedical Research
Madisonville, Kentucky, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
...and 5 more locations