drugset / Trial / NCT00124176

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children

NCT00124176

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis * Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses * Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol. * Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.

Timeline

Start
2004-04
Primary completion
2006-02
Completion
2006-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Levalbuterol Other / unclassified 10 mg Inhaled
Comparator racemic albuterol Unknown 20 mg

Indications