drugset / Trial / NCT00064389

Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

NCT00064389

Phase 3 Completed 746 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.

Timeline

Start
2003-01
Primary completion
2005-07
Completion
2005-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Levalbuterol Other / unclassified 90 ug Inhaled
Comparator racemic albuterol Unknown 180 ug Inhaled

Indications