Alcohol Exposure and Airway Hyperresponsiveness

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: ethanol

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post-alcohol change in airway hyperresponsiveness.; 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.	Other: ethanol; subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in airway hyperresponsiveness.	A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness.	2 hours

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Study Director: Joseph H Sisson, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): January 16, 2013
• Study Completion (Actual): January 16, 2013

Study Registration Dates

• First Submitted: October 2, 2009
• First Submitted That Met QC Criteria: October 5, 2009
• First Posted (Estimated): October 6, 2009

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Respiratory Hypersensitivity; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: 0268-07-FB; 1F32AA017024-01 (U.S. NIH Grant/Contract)