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

This is a single blind (investigator unblinded), open label, single exposure, non-randomized, single center, outpatient, stepwise, rising dose study in male subjects with mild intermittent asthma to assess topical safety and tolerability of Albuterol Sulfate Acu-30™ DPI, compared with Placebo Acu-30™ DPI. Increasing doses of each drug will be administered in a sequential fashion in 4 steps to 3 different subjects at each step (a total of 12 subjects) with mild intermittent asthma in each step.

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