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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