Trial | NCT00565591  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    albuterol ...

  • Study Participants

    12
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.
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.
Study Started
Nov 30
2007
Primary Completion
Jan 31
2008
Study Completion
Feb 29
2008
Last Update
Feb 15
2008
Estimate

Drug Albuterol sulfate

Single dose dry powder by inhalation

Dose escalation Placebo Comparator

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
No Results Posted