The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD
This was a multicenter, open-label, randomized, active controlled, parallel group chronic safety study of arformoterol 50 mcg once daily over a period of 12 months in subjects with COPD. 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
799
Arformoterol inhalation solution, 50 mcg QD
Salmeterol MDI, 42 mcg BID
Overall occurrence of adverse events
Time frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Laboratory parameters
Time frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
ECG parameters
Time frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
24-hour holter monitoring parameters
Time frame: Weeks -1, 0, 13, 26, 39, 52
Vital signs
Time frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Plasma arformoterol concentrations
Time frame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Physical examination findings
Time frame: Weeks -1, 53
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