The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma
A randomized, double-blind, active controlled, multicenter, parallel treatment, 3x3 dose level crossover study evaluating the dose response of levalbuterol in pediatric subjects between the ages of 6 and 11, inclusive with exercise induced bronchoconstriction. 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
33
1. levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each). 2. Arm #A 3. Xopenex HFA MDI
1. racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg). 2. Arm #B 3. Proventil HFA MDI
Unnamed facility
Long Beach, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Englewood, Colorado, United States
Unnamed facility
Russells Mills, Massachusetts, United States
Maximum percent decrease in FEV1 from visit post-dose/pre-challenge FEV1
Time frame: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit post-dose/pre-challenge FEV1 curve
Time frame: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit pre-dose FEV1 curve.
Time frame: Days -7, 0, 5, 10, 15
Minimum percent change in FEV1 from visit pre-dose FEV1.
Time frame: Days -7, 0, 5, 10, 15
Minimum percent change in FEV1 from visit post dose/pre-challenge FEV1
Time frame: Days -7, 0, 5, 10, 15
percent change in FEV1 from visit predose to the post-dose/pre-challenge FEV1
Time frame: Days -7, 0, 5, 10, 15
Time to recovery (min), Protected/Unprotected Subjects Counts
Time frame: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit post-dose/pre-challenge FVC,
Time frame: Days -7, 0, 5, 10, 15
Maximum percent decrease in FVC from visit post-dose/pre-challenge FVC
Time frame: Days -7, 0, 5, 10, 15
Minimum percent change in FVC from pre-dose FVC
Time frame: Days -7, 0, 5, 10, 15
Area under the percent decrease from visit post-dose/pre-challenge FEF25%-75% curve
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Unnamed facility
Dallas, Texas, United States
Unnamed facility
Burke, Virginia, United States
Time frame: Days -7, 0, 5, 10, 15
Maximum percent decrease in FEF25-75% from visit post-dose/pre-challenge FEF25-75%
Time frame: Days -7, 0, 5, 10, 15
Minimum percent change in FEF25%-75% from visit pre-dose FEF25-75%.
Time frame: Days -7, 0, 5, 10, 15