A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler)

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will measure the improvement in lung function in subjects with asthma after inhaling from two inhalers, Albuterol in a dry powder inhaler and albuterol in an HFA (hydrofluoroalkane), metered dose inhaler.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Collaborator: Parexel
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• Must provide written informed consent,

• Must be between 18-45 years of age,

• Male or Female, females of non-child bearing potential or using reliable contraception

• Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180mcg albuterol

• Stable low dose of Inhaled Corticosteroids

• Non-smoker

• Otherwise healthy

• Other criteria apply

Exclusion Criteria:

• Pregnant

• Allergic to albuterol or severe milk protein allergy

• ONLY for subject participating in PK assessments, must not have donated blood within 30 days.

• Other criteria apply