NCT01656811

A 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 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study up to four weeks in duration. Seven days of QID (four times a day) single-blind, placebo administration (via metered dose inhaler (MDI)) was followed by 21 days of QID double-blind treatment. During the single-blind period, rescue medication consisted of racemic albuterol MDI (90 mcg per actuation) for all subjects. During the double-blind period, rescue medication consisted of double-blind levalbuterol MDI (45 mcg per actuation) for all subjects in the levalbuterol treatment groups or double-blind racemic albuterol MDI (90 mcg per actuation) for all subjects in the racemic albuterol and placebo treatment groups.The study consisted of two periods, an optional follow-up visit, and a final telephone evaluation. This study was previously conducted 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 90 mcg	90 mcg levalbuterol delivered via MDI 2 actuations of 45 mcg QID
DRUG	levalbuterol 180 mcg	180 mcg levalbuterol delivered via MDI 2 actuations of 90 mcg QID
DRUG	racemic albuterol 180 mcg	180 mcg racemic albuterol delivered via MDI 2 actuations of 90 mcg QID
DRUG	Placebo	Placebo 2 actuations QID

Timeline

• Start date: 2001-10-01
• Primary completion: 2002-07-01
• Completion: 2002-07-01
• First posted: 2012-08-03
• Last updated: 2012-08-03