Skip to content

Mechanisms of Alcohol Sensitivity in AERD

Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03441438
Enrollment
60
Registered
2018-02-22
Start date
2018-05-01
Completion date
2018-09-01
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspirin-Sensitive Asthma With Nasal Polyps, Samter's Syndrome

Keywords

alcohol sensitivity, red wine, aerd

Brief summary

The purpose of this study is to determine what type of reactions in the body may be responsible for the respiratory symptoms that occur when patients with Aspirin Exacerbated Respiratory Disease (AERD) drink alcoholic beverages. These reactions are most often seen with red wine.

Detailed description

This is a prospective trial of approximately 60 subjects with AERD to explore the mechanisms behind the physiologic reactions that occur when drinking alcoholic beverages. At various time points patients will be asked to ingest a variety of substances found in red wine after which blood and urine markers of the reaction will be measured.

Interventions

DIETARY_SUPPLEMENTWater

Serum and urine markers will be obtained after drinking 5 oz of water

DIETARY_SUPPLEMENTRed wine

Serum and urine markers will be obtained after drinking 5 oz of water

DIETARY_SUPPLEMENTPolyphenolic Compounds

Serum and urine markers will be obtained after consuming 100 mg of provinols powder

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy Controls - must be 21 years or older * Aspirin Tolerant Asthma and AERD arms must note a sensitivity to alcoholic beverages

Exclusion criteria

* Enzymopathies * Mastocytosis * Alcoholism * Prior severe respiratory reaction to alcohol consumption * Current pregnancy * Monoamine Oxidase Inhibitor (MAOI) use * Age under 21 * Use of leukotriene modifier 1 week before study intervention * Having undergone and maintained aspirin desensitization

Design outcomes

Primary

MeasureTime frameDescription
24 Hour Urinary Leukotriene-E4 (LTE4)24 hourUrine LTE4 ng/mg Cr

Secondary

MeasureTime frameDescription
24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite24 hour collectionUrine PGD2 metabolite ng/mg Cr
Whole blood Activated Basophil Level2 hours after ingestionProportion of activated basophils in whole blood after ingestion
Whole Blood Activated Eosinophil Level2 hours after ingestionProportion of activated eosinophils in whole blood after ingestion
Whole Blood tryptase2 hours after ingestionLevel of tryptase concentration in whole blood

Countries

United States

Contacts

Primary ContactBJ Ferrebee-Ghamandi, MHA
Bjf8j@hscmail.mcc.virginia.edu434-243-1558

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026