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Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI
This study has been completed.
Study NCT00565591   Information provided by Respirics Inc.
First Received: November 29, 2007   Last Updated: February 12, 2008   History of Changes

November 29, 2007
February 12, 2008
November 2007
January 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00565591 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
 
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

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.

Phase I
Interventional
Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety Study
Allergic Asthma
Drug: Albuterol sulfate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
12
February 2008
January 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00565591
Andre van As MD PhD, Respirics Inc.
RA1101C
Respirics Inc.
 
Principal Investigator: Holly Brown, MD Private practise
Respirics Inc.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP