Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI
Overview
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 Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: January 2008
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.
Interventions
- Drug: Albuterol sulfate
- Single dose dry powder by inhalation
Arms, Groups and Cohorts
- Placebo Comparator: Dose escalation
Clinical Trial Outcome Measures
Primary Measures
- 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.
- Time Frame: 3 hours
Secondary Measures
- 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.
- Time Frame: 3 hours
Participating in This Clinical Trial
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
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Respirics Inc.
- Provider of Information About this Clinical Study
- Andre van As MD PhD, Respirics Inc.
- Overall Official(s)
- Holly Brown, MD, Principal Investigator, Private practise
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