Expired Study
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Iowa City, Iowa 52240


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00565591


Primary Contact:

Principal Investigator
Holly Brown, MD
Private practise


Backup Contact:

N/A


Location Contact:

Iowa City, Iowa 52240
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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