Status:
COMPLETED
Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.
Eligibility Criteria
Inclusion
- Persistent asthma for a minimum of six months duration that has been stable for at least four weeks
- Predicted FEV1 60-90%
- Demonstration of 12% airway reversibility
Exclusion
- Continuous requirement for beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, anticholinergics and/or steroids other than those inhaled;
- Presence of clinically-significant non-asthmatic acute or chronic disease
Key Trial Info
Start Date :
June 30 2005
Trial Type :
INTERVENTIONAL
End Date :
September 30 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00112411
Start Date
June 30 2005
End Date
September 30 2005
Last Update
December 8 2021
Active Locations (9)
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1
Allergy Associates Medical Group, Inc.
San Diego, California, United States, 92120
2
Aeroallergy Research Labs of Savannah, Inc.
Savannah, Georgia, United States, 31409
3
University of Louisville
Louisville, Kentucky, United States, 40202
4
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States, 02747