Mechanisms of Alcohol Sensitivity in AERD

Not Applicable

• Conditions: Aspirin-Sensitive Asthma With Nasal Polyps; Samter's Syndrome
• Interventions: Dietary Supplement: Water; Dietary Supplement: Red wine; Dietary Supplement: Polyphenolic Compounds

• Registration Number: NCT03441438
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-22
• Status Verified: 2018-05
• Study Start: 2018-05-01
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-07
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin Intolerant Asthma / AERD	Polyphenolic Compounds	Patients with AERD who note sensitivity to alcoholic beverages
Control	Water	Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages
Aspirin Tolerant Asthma	Red wine	Patients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages
Aspirin Tolerant Asthma	Polyphenolic Compounds	Patients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages
Aspirin Tolerant Asthma	Water	Patients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages
Aspirin Intolerant Asthma / AERD	Water	Patients with AERD who note sensitivity to alcoholic beverages
Control	Red wine	Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages
Control	Polyphenolic Compounds	Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages
Aspirin Intolerant Asthma / AERD	Red wine	Patients with AERD who note sensitivity to alcoholic beverages

Primary Outcome Measures

Name	Time	Method
24 Hour Urinary Leukotriene-E4 (LTE4)	24 hour	Urine LTE4 ng/mg Cr

Secondary Outcome Measures

Name	Time	Method
24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite	24 hour collection	Urine PGD2 metabolite ng/mg Cr
Whole blood Activated Basophil Level	2 hours after ingestion	Proportion of activated basophils in whole blood after ingestion
Whole Blood tryptase	2 hours after ingestion	Level of tryptase concentration in whole blood
Whole Blood Activated Eosinophil Level	2 hours after ingestion	Proportion of activated eosinophils in whole blood after ingestion

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States