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

Condition(s) targeted: Allergic Asthma

Intervention: Albuterol sulfate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Respirics Inc.

Official(s) and/or principal investigator(s):
Holly Brown, MD, Principal Investigator, Affiliation: Private practise

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.

Official title: A Stepwise, Rising Dose Study of Male Subjects With Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI Compared With Placebo Acu-30™ DPI

Study design: Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety Study

Primary outcome: To assess the safety and tolerability of Albuterol Sulfate Acu-30™ DPI compared with Placebo Acu-30™ DPI in male volunteers with mild intermittent asthma.

Secondary outcome: To perform an exploratory assessment of the pharmacokinetics (PK) of a single dose of Albuterol Sulfate Acu-30™ in a limited population of male volunteers with mild intermittent asthma.

Detailed 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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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

Iowa Clinical Research Corporation, Iowa City, Iowa 52240, United States

Starting date: November 2007
Ending date: February 2008
Last updated: February 12, 2008