NCT00685022

Safety and Tolerability Study of Levalbuterol HFA Compared to Racemic Albuterol HFA in Subjects With Asthma

A Cumulative Dose Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Subjects Twelve Years of Age and Older With Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI.

Detailed description

A randomized, modified-blind active-controlled multicenter, two-way crossover study of HFA levalbuterol (without using a spacer) in subjects 12 years of age and older with asthma. 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 HFA MDI followed by Racemic albuterol HFA MDI	1. Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) 2. Arm #A 3. Xopenex HFA MDI, albuterol HFA MDI
DRUG	Racemic Albuterol followed by levalbuterol HFA MDI	1. Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) 2. Arm #B 3. albuterol HFA MDI, Xopenex HFA MDI

Timeline

• Start date: 2003-06-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2008-05-28
• Last updated: 2012-02-22

Locations

3 sites across 1 country: United States