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

Teva Branded Pharmaceutical Products R&D, Inc.9 sites in 1 countryJune 30, 2005

ConditionsAsthma

DrugsBronchodilator

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Locations: 9
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 30, 2005

End Date

September 30, 2005

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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