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

Respirics

Status and phase

Completed

Phase 1

Conditions

Allergic Asthma

Treatments

Drug: Albuterol sulfate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00565591

RA1101C

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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