The purpose of this study is to compare the blood levels of arformoterol tartrate inhalation solution to racemic formoterol in male and female subjects with mild to moderate Chronic Obstructive Pulmonary Disease (COPD).
This is an open label, randomized, multiple dose, 3-way crossover, multicenter, inpatient and outpatient study to compare the pharmacokinetic (PK) profile of arformoterol tartrate inhalation solution and Foradil® in male and female subjects with mild to moderate COPD. Up to 36 subjects (with a minimum 40% of each gender) were to be randomized to ensure that at minimum 24 subjects completed the study. The study included 3 dose periods and 3 washout periods. Subjects received 3 different treatments in random order for 13 consecutive days and a single dose on the morning of the 14th day. Subjects will be randomly assigned to 1 of the 6 possible treatment sequences. During each dose period, subjects received medication via nebulization or DPI twice daily for 13 consecutive days and a single dose on the morning of the 14th day. There was be a 10 day washout period between each treatment. Subject participation was be approximately 13 weeks and included a screening visit and 7 study visits. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
12 µg of racemic formoterol fumarate BID
15 µg of nebulized arformoterol tartrate inhalation solution BID
24 µg of racemic formoterol fumarate BID
Unnamed facility
Long Beach, California, United States
Unnamed facility
Fort Lauderdale, Florida, United States
Unnamed facility
Raleigh, North Carolina, United States
Unnamed facility
Simpsonville, South Carolina, United States
The primary endpoint for this study is exposure to (R,R)-formoterol, measured by the PK parameters AUC(0-τ) and Cmax
Time frame: Treatment/Washout 1: Days 1, 12-18; T/W 2: 24, 35-40; T/W 3: 47, 58-64, EOT: 70
Additional PK parameters of (R,R)-formoterol include tmax, t ½, and AUC(0-∞)
Time frame: Treatment/Washout 1: Days 1, 12-18; T/W 2: 24, 35-40; T/W 3: 47, 58-64, EOT: 70
Accumulation ratios for (R,R)-formoterol as measured by RCmax and RAUC(0-τ)
Time frame: Treatment/Washout 1: Days 1, 12-18; T/W 2: 24, 35-40; T/W 3: 47, 58-64, EOT: 70
PK parameters for (S,S)-formoterol following racemic formoterol administration are AUC(0-τ), Cmax, tmax, t ½, and AUC(0-∞)
Time frame: Treatment/Washout 1: Days 1, 12-18; T/W 2: 24, 35-40; T/W 3: 47, 58-64, EOT: 70
Accumulation ratios for (S,S)-formoterol as measured by RCmax and RAUC(0-τ)
Time frame: Days 1, 12, 13, 14, 15, 16, 17,18
FEV1 and % predicted FEV1
Time frame: Treatment/Washout 1: Days 1, 14-15; TW2: 24, 37-38; TW3: 47, 60-61
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Unnamed facility
Spartanburg, South Carolina, United States
Unnamed facility
Spokane, Washington, United States