The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.
A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease. 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
117
Nebulized unit dose vial for inhalation, low dose (0.15 mg, 0.31 mg or 0.63 mg), adjusted for body weight
Nebulized unit dose vial for inhalation, high dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
Nebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
Unnamed facility
Little Rock, Arkansas, United States
Maximum decrease in Respiratory Status Scale© total score
Time frame: Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged
Time to meet discharge criteria or clinical decision to discharge.
Time frame: Days 0-7
Time to maximum decrease in Respiratory Status Scale© total score.
Time frame: Days 0-7
Individual Respiratory Status Scale© items.
Time frame: Days 0-7
Time to hospitalization.
Time frame: Days 0-7
Rate of hospitalization.
Time frame: Days 0-7
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Unnamed facility
Corona, California, United States
Unnamed facility
Englewood, California, United States
Unnamed facility
Huntington Beach, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Lake Worth, Florida, United States
...and 24 more locations