Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.

• 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: Albuterol

Criteria

Inclusion Criteria:

• Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening

• Poor inhaler coordination as assessed at screening

• Reversible bronchoconstriction (≥ 12% increase in FEV1)

Exclusion Criteria:

• Albuterol allergy

• Investigational drug within 30 days

• Injected corticosteroid within 6 weeks

• Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled

• Other criterial apply