Alcohol Exposure and Airway Hyperresponsiveness

Healthy Clinical Trial

Official title:

Alcohol Exposure and Airway Hyperresponsiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990275
• Other study ID #: 0268-07-FB
• Secondary ID: 1F32AA017024-01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2009
• Est. completion date: January 16, 2013

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alcohol has consequences including increased risk for upper respiratory tract infections, pneumonia, acute respiratory distress syndrome (ARDS), and alcohol-induced asthma. The investigators have established that airways are specifically impacted by alcohol exposure because the airways are heavily exposed to the vapor phase of alcohol during drinking. These preliminary studies demonstrate that brief alcohol administration significantly attenuates airway hyperresponsiveness (AHR) in a mouse model leading to the hypothesis that alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 16, 2013
• Est. primary completion date: January 16, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Respiratory Hypersensitivity

Intervention

Other:
• ethanol
subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in airway hyperresponsiveness.	A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness.	2 hours