NCT00667407

Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma

A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 627 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.

Detailed description

This study is a double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in adult subjects with acute reversible airways disease. Approximately 600 subjects will be enrolled and study participation will consist of 2 periods: Period I (Acute Period): Double-blind treatment in the Emergency Department (ED) or Clinic until disposition, for a maximum of 24 hours of double-blind treatment and Period II (Post-Acute Period): Subjects discharged from the ED or Clinic will continue double blind treatment (with the same treatment provided as rescue medication as MDI) for approximately 10 days. Subjects will be contacted by telephone 30 days post discharge to assess relapse. 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 1.25 mg	levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated. Period II: TID for 3 days (same time of day), then PRN to TID for 7 days
DRUG	Racemic Albuterol Sulfate	Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated. Period II: TID for 3 days then PRN to TID for 7 days

Timeline

• Start date: 2000-11-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2008-04-28
• Last updated: 2012-02-22

Locations

28 sites across 1 country: United States