Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Bronchodilator Agents

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