NCT00073827

Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 445 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

Detailed description

This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	levalbuterol tartrate MDI	levalbuterol 90 mcg QID
DRUG	racemic albuterol MDI	racemic albuterol 180 mcg QID
DRUG	Placebo	Placebo MDI QID

Timeline

• Start date: 2002-05-01
• Primary completion: 2003-01-01
• Completion: 2003-01-01
• First posted: 2003-12-11
• Last updated: 2012-02-22

Locations

63 sites across 1 country: United States