Alcohol Exposure and Airway Hyperresponsiveness

NCT00990275 | Completed

• 2 other identifiers: 0268-07-FB1F32AA017024-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in airway hyperresponsiveness.

  A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness.

  2 hours

Study Arms (1)

Post-alcohol change in airway hyperresponsiveness.

EXPERIMENTAL

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

Interventions

ethanol OTHER

subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.

Post-alcohol change in airway hyperresponsiveness.

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Joseph H Sisson, MD

  University of Nebraska

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 6, 2009
• Study Start: October 1, 2009
• Primary Completion: January 16, 2013
• Study Completion: January 16, 2013
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

US (1)