A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma

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

Summary

This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.

• 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; Procaterol

Criteria

Inclusion Criteria:

• Must provide written informed consent,

• Be between 12 years of age and older,

• 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 180 mcg albuterol

• Stable low dose of Inhaled Corticosteroids

• Non-smoker, 12 months smoking-free and <=10-pack years history

• Otherwise healthy

• Other criteria apply

Exclusion Criteria:

• Pregnant

• Allergic to albuterol or severe milk protein allergy

• Must not be on another trial for 30days.

• Other criteria apply