NCT00809757

A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma

A Safety, Efficacy, and Tolerability Study of Daily Dosing With Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months With Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 48 Months
• Healthy volunteers: Not accepted

Summary

A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to \<48 Months with Asthma.

Detailed description

This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to \<48 months 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	90 ug Levalbuterol (2 actuations)
DRUG	Levalbuterol UDV TID	0.31 ug Levalbuterol UDV TID
DRUG	Placebo	Placebo (2 actuations)

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2008-12-17
• Last updated: 2014-07-28
• Results posted: 2014-07-28

Locations

46 sites across 1 country: United States