Status:
COMPLETED
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing ...
Eligibility Criteria
Inclusion
- Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening
- Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
- Ability to perform spirometry
- Demonstrate 12% airways reversibility
Exclusion
- Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
- Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases
Key Trial Info
Start Date :
June 10 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2006
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00308685
Start Date
June 10 2006
End Date
December 4 2006
Last Update
April 1 2022
Active Locations (14)
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1
Little Rock Allergy and Asthma
Little Rock, Arkansas, United States, 72205-4565
2
Allergy & Asthma Specialist Medical Group
Huntington Beach, California, United States, 92647
3
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States, 95117
4
William Storms Medical Research
Colorado Springs, Colorado, United States, 80907