The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).
This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. 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
TRIPLE
Enrollment
445
percent change in FEV1 from visit predose averaged over the 8-week double-blind period
Time frame: Weeks 0, 4, 8
area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period
Time frame: Weeks 0, 4, 8
peak percent change in FEV1 from study baseline
Time frame: Weeks 0, 4, 8
peak change in FEV1 from visit predose
Time frame: Weeks 0, 4, 8
peak percent of predicted FEV1
Time frame: Weeks 0, 4, 8
area under the FEV1 curve (AUC)
Time frame: Weeks 0, 4, 8
peak change and peak percent change in FEF25-75% from visit predose
Time frame: Weeks 0, 4, 8
peak change and peak percent change in FVC from visit predose
Time frame: Weeks 0, 4, 8
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