MedPath

Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

Phase 2
Completed
Conditions
Asthma
Registration Number
NCT00112411
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
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

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (9)

University of Louisville

🇺🇸

Louisville, Kentucky, 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

Mississippi Asthma and Allergy Clinic

🇺🇸

Jackson, Mississippi, United States

Northeast Medical Research Associates, Inc.

🇺🇸

North Dartmouth, Massachusetts, United States

Allergy and Asthma Research Group

🇺🇸

Eugene, Oregon, United States

Allergy Associates Research Center

🇺🇸

Portland, Oregon, United States

Medical Research Network

🇺🇸

The Woodlands, Texas, United States

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