The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma
A randomized, double-blind, active-controlled multicenter, two-way crossover study of HFA levalbuterol (with and without a spacer) in subjects 4-11 years of age with asthma. 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
31
(a) Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses)
(a) Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)
Unnamed facility
Madera, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Savannah, Georgia, United States
Unnamed facility
Louisville, Kentucky, United States
Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic), potassium and glucose
Time frame: 0, 7, 10 days
Percent change in FEV1 (from visit pre-dose to each post dose measure)
Time frame: Days 0, 7, 10
Percent change in FVC (from visit pre-dose to each post dose measure)
Time frame: Days 0, 7, 10
Percent change in FEF25-75% (from visit pre-dose to each post dose measure)
Time frame: Days 0, 7, 10
Number of cumulative actuations received
Time frame: Days 0, 7, 10
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Unnamed facility
Cortland, New York, United States
Unnamed facility
Medford, Oregon, United States
Unnamed facility
Portland, Oregon, United States
Unnamed facility
Chester, Pennsylvania, United States
Unnamed facility
Knoxville, Tennessee, United States
Unnamed facility
Dallas, Texas, United States
...and 1 more locations