The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in adolescent and adult subjects with asthma
A randomized, modified-blind, active controlled, multicenter, parallel treatment, 3x3 dose level crossover study evaluating the dose response of levalbuterol in subjects 12 years of age and older 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
62
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
Los Angeles, California, United States
Unnamed facility
Signal Hill, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
FEV1 AUC 0-60 (% decrease from post-dose/pre-challenge FEV1)
Time frame: Days -7, 0, 5, 10, 15
Maximum percent decrease in FEV1 from visit post-dose/pre-challenge FEV1
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
time to recovery (min), Protected/Unprotected Subjects Counts
Time frame: Days -7, 0, 5, 10, 15
FVC AUC 0-60 (% decrease from post-dose/pre-challenge FEV1).
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 for pre-dose FVC,
Time frame: Days -7, 0, 5, 10, 15
FEF25-75% AUC 0-60 (% decrease from post-dose/pre-challenge FEV1),
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
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Burke, Virginia, United States