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Alcohol Exposure and Airway Hyperresponsiveness

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ClinicalTrials.gov Identifier: NCT00990275
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Healthy Other: ethanol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Alcohol Exposure and Airway Hyperresponsiveness
Study Start Date : October 2009
Primary Completion Date : January 2013
Study Completion Date : January 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: Post-alcohol Other: ethanol
subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.


Outcome Measures

Primary Outcome Measures :
  1. A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness. [ Time Frame: 2 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990275


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5910
Sponsors and Collaborators
University of Nebraska
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Study Director: Joseph H Sisson, MD University of Nebraska
More Information

Responsible Party: Lisa Chudomelka, Admin Research Associate, University of Nebraska
ClinicalTrials.gov Identifier: NCT00990275     History of Changes
Other Study ID Numbers: 268-07
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Respiratory Hypersensitivity
Respiratory Tract Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs