Alcohol Exposure and Airway Hyperresponsiveness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lisa Chudomelka, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00990275
First received: October 2, 2009
Last updated: August 30, 2011
Last verified: August 2011

October 2, 2009
August 30, 2011
October 2009
May 2012   (final data collection date for primary outcome measure)
A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00990275 on ClinicalTrials.gov Archive Site
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Alcohol Exposure and Airway Hyperresponsiveness
Alcohol Exposure and Airway Hyperresponsiveness

Alcohol has well-established consequences in the lung including increased risk for upper respiratory tract infections, pneumonia and acute respiratory distress syndrome (ARDS). There have even been a few reports of alcohol-induced asthma. Data from the investigators' laboratory have established that the airways are specifically impacted by alcohol exposure. Because the airways are heavily exposed to the vapor phase of alcohol during drinking and airway motor tone is modulated by cAMP, the investigators speculated that airway bronchial motor function would be altered in mice fed alcohol. The investigators' preliminary studies demonstrate that brief alcohol administration significantly attenuates airway hyperresponsiveness (AHR) in a mouse model. This novel finding has led us to hypothesize that:

Alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.

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Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Other: ethanol
subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.
Experimental: Post-alcohol
Intervention: Other: ethanol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male
  • must be of legal drinking age in the state of Nebraska (≥ 21)
  • be between the ages of 21-65
  • be non-smokers
  • be able to dedicate 3-4 hours on two consecutive days (including waiting at least 2 hours after the alcohol ingestion)
  • able to provide informed consent

Exclusion Criteria:

  • female
  • inability to give informed consent
  • any history of lung or allergic disease
  • any alcohol intake for the week prior to the experiment
  • self-identified history of chronic heavy drinking or alcoholism or psychiatric disorder
  • If an otherwise qualifying participant has previously undocumented or unidentified asthma as indicated by the baseline methacholine challenge, that subject will be excluded from the remainder of the study and replaced by another subject
Male
21 Years to 65 Years
Yes
Contact: Joseph H Sisson, MD 402 559 8834 jsisson@unmc.edu
United States
 
NCT00990275
268-07
No
Lisa Chudomelka, University of Nebraska
University of Nebraska
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Director: Joseph H Sisson, MD University of Nebraska
University of Nebraska
August 2011

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