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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
746
levalbuterol MDI 90 mcg QID
racemic albuterol HFA MDI 180 mcg QID
incidence of post-randomization adverse events
Time frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
rate of discontinuations due to adverse events
Time frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
time-to-selected adverse events (AEs with an incidence ≥5%)
Time frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
asthma attacks, asthma adverse events, and expanded-definition asthma events
Time frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
clinical laboratory values
Time frame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53
vital signs (blood pressure, heart rate, respiration rate, and body temperature)
Time frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53
ECG parameters
Time frame: Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53
physical examinations
Time frame: Weeks -1, 0, 26, 27, 52, 53
rescue medication, and daytime asthma control days
Time frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
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Jefferson Clinic PC
Birmington, Alabama, United States
Pulmonary Associates Research Division
Mobile, Alabama, United States
Montgomery Pulmonary Consultants
Montgomery, Alabama, United States
Center of Research Excellence, LLC
Oxford, Alabama, United States
Lovelace Scientific Resources
Phoenix, Arizona, United States
Alta Clinical Research, LLC
Tucson, Arizona, United States
Integrated Research Group
Corona, California, United States
Northern California Research Corp
Fair Oaks, California, United States
Allergy, Asthma & Respiratory Care Center
Long Beach, California, United States
Madera Family Medical Group
Madera, California, United States
...and 86 more locations
FEV1, FVC, FEF25-75%, peak expiratory flow
Time frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Weeks 0, 26, 27, 52, 53
subject and physician global evaluations
Time frame: Weeks 26, 27, 52, 53
(S) and (R) albuterol plasma concentrations
Time frame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53
subject assessment of study inhaler device performance
Time frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53