Asthma Clinical Trial
Official title:
Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.
This was a randomized, open-label, active controlled, multicenter, parallel-group safety
study in subjects 12 years of age and older with asthma. Subjects of appropriate age who
completed the Phase III levalbuterol HFA MDI trials (Studies 051-353 or 051-355) were
eligible to participate. Studies 051-353 and 051-355, both entitled "An Efficacy and Safety
Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and
Older with Asthma" were multicenter, randomized, double-blind, placebo- and
active-controlled, parallel-group studies of up to nine weeks in duration (a one-week
single-blind placebo run in period followed by an eight-week double-blind treatment period).
Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to
rollover into the current study could also participate but only after a 30-day washout. New
subjects and subjects who participated in the Phase III trials who were not immediately
eligible (ie, had a >30-day washout) were considered to be de novo subjects.Study
participation included 10 study visits over a 12 month period.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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