NCT00577655

Albuterol HFA MDI in Pediatric Participants With Asthma

Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Albuterol	Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days.
DRUG	Placebo	Placebo HFA MDI four times a day (q.i.d) for 21 days.
DRUG	Proventil® HFA	Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-12-20
• Last updated: 2021-11-12
• Results posted: 2009-12-03

Locations

13 sites across 1 country: United States