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
  Purpose

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 Intervention
Healthy
Other: ethanol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Alcohol Exposure and Airway Hyperresponsiveness

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: October 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post-alcohol Other: ethanol
subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990275

Contacts
Contact: Joseph H Sisson, MD 402 559 8834 jsisson@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-5910
Principal Investigator: Joseph H Sisson, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Study Director: Joseph H Sisson, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Lisa Chudomelka, Admin Research Associate, University of Nebraska
ClinicalTrials.gov Identifier: NCT00990275     History of Changes
Other Study ID Numbers: 268-07
Study First Received: October 2, 2009
Last Updated: August 30, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014