NCT00685347

Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects

A Dose Response Study of Levalbuterol and Racemic Albuterol HFA MDI in Pediatric Subjects With Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma

Detailed description

A randomized, double-blind, active controlled, multicenter, parallel treatment, 3x3 dose level crossover study evaluating the dose response of levalbuterol in pediatric subjects between the ages of 6 and 11, inclusive with exercise induced bronchoconstriction. 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
• Bronchoconstriction

Interventions

Type	Name	Description
DRUG	Levalbuterol HFA MDI	1. levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each). 2. Arm #A 3. Xopenex HFA MDI
DRUG	Racemic Albuterol	1. racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg). 2. Arm #B 3. Proventil HFA MDI

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2008-05-28
• Last updated: 2012-02-22

Locations

6 sites across 1 country: United States