A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol (given once or twice a day) in subjects with COPD.
This study is a double-blind, repeat-dose, randomized, multicenter, two-part, parallel-group, dose-ranging study of arformoterol and placebo in the treatment of subjects with COPD. Approximately 215 subjects will be randomized in this study. Study participation will consist of a total of eight (8) study visits over approximately ten (10) weeks for each subject. 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
DOUBLE
Enrollment
215
Arformoterol 5 mcg BID
Arformoterol 15 mcg BID
Arformoterol 25 mcg BID
Unnamed facility
Encinitas, California, United States
Part A: The primary efficacy endpoint is the time-normalized area under the FEV1 percent change from pre-dose curve over 12 hours (nAUC0-12) after the first (AM) dose at the 24 hour clinic visit (Visit 4) following 14 days of double-blind treatment.
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Part B: The primary efficacy endpoint is the time-normalized area under the FEV1 percent change from pre-dose curve over 24 hours (nAUC0-24) at the 24 hour clinic visit (Visit 7) following 14 days of double-blind treatment.
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Relationship between plasma concentrations of arformoterol and changes in ECG QTc intervals at steady state throughout the dosing interval.
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Part A only: Time-normalized area under the curve for FEV1 percent change from pre-dose over 24 hours (nAUC0-24) for each 24 hour clinic visit.
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14),
Part B only: Time-normalized area under curve for the FEV1 percent change from pre-dose over 12 hours (nAUC0-12) for each 24 hour clinic visit.
Time frame: Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Time-normalized area under the curve for the percent change in FEV1 from pre-dose over 6 hours (nAUC0-6) for the 6 hour clinic visit (Visits 3 and 6).
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Placebo inhalation solution BID
Arformoterol 15 mcg QD
Arformoterol 25 mcg QD
Arformoterol 50 mcg QD
Placebo inhalation solution QD
Unnamed facility
Long Beach, California, United States
Unnamed facility
Brandon, Florida, United States
Unnamed facility
Cleawater, Florida, United States
Unnamed facility
Fort Lauderdale, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Port Orange, Florida, United States
Unnamed facility
West Palm Beach, Florida, United States
Unnamed facility
Austell, Georgia, United States
Unnamed facility
Topeka, Kansas, United States
...and 21 more locations
Percent change in FEV1 from pre-dose to each post dose time point
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Peak percent change in FEV1 post-dose
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Ipratropium bromide metered-dose inhaler (MDI) use and racemic albuterol MDI use
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Morning and evening peak expiratory flow rate (PEFR)
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Exacerbations of COPD
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
COPD symptom ratings
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Effects of withdrawal from therapy
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
Relationship between plasma concentrations of (R,R)-formoterol and selected pharmacodynamic parameters.
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
FEV1 percent change from pre-dose (24-hour trough) following 14 days of double-blind treatment.
Time frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)