Alcohol Exposure and Airway Hyperresponsiveness
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ethanol
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility 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
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Post-alcohol change in airway hyperresponsiveness.
Arm Description
Participants will ingest 3 ounces of vodka mixed with fruit juice within 30 min. Then provocative concentration causing a 20% fall in forced expiratory volume in 1 s (PC20FEV1) will be measured. A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness.
Outcomes
Primary Outcome Measures
Change in airway hyperresponsiveness.
A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness.
Secondary Outcome Measures
Full Information
NCT ID
NCT00990275
First Posted
October 2, 2009
Last Updated
August 30, 2023
Sponsor
University of Nebraska
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00990275
Brief Title
Alcohol Exposure and Airway Hyperresponsiveness
Official Title
Alcohol Exposure and Airway Hyperresponsiveness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (Actual)
Primary Completion Date
January 16, 2013 (Actual)
Study Completion Date
January 16, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Post-alcohol change in airway hyperresponsiveness.
Arm Type
Experimental
Arm Description
Participants will ingest 3 ounces of vodka mixed with fruit juice within 30 min. Then provocative concentration causing a 20% fall in forced expiratory volume in 1 s (PC20FEV1) will be measured. A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness.
Intervention Type
Other
Intervention Name(s)
ethanol
Intervention Description
subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.
Primary Outcome Measure Information:
Title
Change in airway hyperresponsiveness.
Description
A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness.
Time Frame
2 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph H Sisson, MD
Organizational Affiliation
University of Nebraska
Official's Role
Study Director
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Alcohol Exposure and Airway Hyperresponsiveness
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