Overview

Albuterol HFA MDI in Pediatric Participants With Asthma

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Branded Pharmaceutical Products, R&D Inc.
Treatments:
Albuterol
Criteria
Inclusion Criteria:

- Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months
duration that has been stable for at least four weeks prior to screening.

Exclusion Criteria:

- Hospitalization for acute asthma exacerbation greater than two years in 12 months
prior to screening and/or received ER treatment or hospitalization for asthma
exacerbation.