NCT00073814

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

An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET. 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 MDI 90 mcg QID
DRUG	racemic albuterol MDI	racemic albuterol MDI 180 mcg QID
DRUG	Placebo	Placebo MDI QID

Timeline

• Start date: 2002-12-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2003-12-10
• Last updated: 2012-02-22

Locations

45 sites across 1 country: United States