Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
Overview
This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.
Full Title of Study: “Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Double
- Study Primary Completion Date: September 30, 2005
Interventions
- Drug: Bronchodilator
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 4 Years
Maximum Age: 11 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Provider of Information About this Clinical Study
- Sponsor
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