Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

This open label single blind study will determine the safety of albuterol sulfate dry powder in a novel inhaler by observing for the potential occurrence of reflex bronchial constriction after inhalation of increasing doses of the compound.

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

Details

• Lead Sponsor: Respirics Inc.
• Treatments: Albuterol

Criteria

Inclusion Criteria

• Mild intermittent asthma (meeting GINA specifications - www.ginasthma.com)

• Medically normal subjects with no significant abnormal findings

• No tobacco (nicotine products) use for at least 2 years before the study starts

• Normal (or abnormal and clinically insignificant) laboratory values at screening (potassium or glucose levels)

• No significant medical or surgical conditions (COPD, cystic fibrosis, severe allergic rhinitis)

Exclusion Criteria:

• Past or present history of experiencing any allergic reaction to the medications/formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity

• Subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator