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drugset / Trial / NCT00685126

Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)

NCT00685126 ↗

Phase 3 Completed 117 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2001-02
Primary completion
2002-07
Completion
2002-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Levalbuterol Other / unclassified 0.15 mg Inhaled
Subject Levalbuterol Other / unclassified 0.31 mg Inhaled
Subject Levalbuterol Other / unclassified 0.63 mg Inhaled
Subject Levalbuterol Other / unclassified 1.25 mg Inhaled
Comparator Salbutamol Unknown 0.31 mg Inhaled
Comparator Salbutamol Unknown 0.63 mg Inhaled
Comparator Salbutamol Unknown 1.25 mg Inhaled
Comparator Salbutamol Unknown 2.5 mg Inhaled

Indications

reactive airway disease