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NCT00112411 Clinical Trial

Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

Asthma Clinical Trial

Official title:
Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00112411
Other study ID # IXR-204-25-167
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 30, 2005
Est. completion date September 30, 2005

Study information
Verified date December 2021
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 30, 2005
Est. primary completion date September 30, 2005
Accepts healthy volunteers No
Gender All
Age group 4 Years to 11 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bronchodilator

Locations
Country Name City State
United States Allergy and Asthma Research Group Eugene Oregon
United States Mississippi Asthma and Allergy Clinic Jackson Mississippi
United States University of Louisville Louisville Kentucky
United States Northeast Medical Research Associates, Inc. North Dartmouth Massachusetts
United States Allergy Associates Research Center Portland Oregon
United States North Carolina Clinical Research Raleigh North Carolina
United States Allergy Associates Medical Group, Inc. San Diego California
United States Aeroallergy Research Labs of Savannah, Inc. Savannah Georgia
United States Medical Research Network The Woodlands Texas

Sponsors (1)
Lead Sponsor Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

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