Alcohol Exposure and Airway Hyperresponsiveness
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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 |
- 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 |
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| Contact: Joseph H Sisson, MD | 402 559 8834 | jsisson@unmc.edu |
| United States, Nebraska | |
| University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198-5910 | |
| Principal Investigator: Joseph H Sisson, MD | |
| 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 May 22, 2013