drugset
drugset / Trial / NCT00809757

A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma

NCT00809757 ↗

Phase 3 Completed 197 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to \<48 Months with Asthma.

Timeline

Start
2008-12
Primary completion
2013-06
Completion
2013-06

Outcome

Missed primary endpoint

registry Placebo vs Levalbuterol MDI; Mean Difference (Final Values) -0.54 (95% CI -1.412 to 0.342) NCT00809757 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Levalbuterol Other / unclassified 0.31 ug Inhaled
Subject Levalbuterol Other / unclassified 90 ug Inhaled

Indications

asthma