drugset / Trial / NCT01656811

A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

NCT01656811

Phase 2 Completed 146 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study of up to four weeks in duration. The study consisted of a screening visit followed by a one-week single blind placebo period. At next visit, each subject was randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180 mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4 times a day for 21 days.

Timeline

Start
2001-10
Primary completion
2002-07
Completion
2002-07

Drugs

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

Indications