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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Allergic Asthma

Intervention / Treatment
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* Drug: Albuterol sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Dose escalation<br> | Drug: Albuterol sulfate<br>* Single dose dry powder by inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, inhaler device, albuterol sulfate