Mechanisms of Alcohol Sensitivity in AERD

University of Virginia

Status: Unknown

Conditions: Samter's Syndrome; Aspirin-Sensitive Asthma With Nasal Polyps

Treatments: Dietary Supplement: Red wine; Dietary Supplement: Polyphenolic Compounds; Dietary Supplement: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT03441438

20382

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Control

Active Comparator group

Description:

Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages

Treatment:

Dietary Supplement: Red wine

Dietary Supplement: Polyphenolic Compounds

Dietary Supplement: Water

Aspirin Tolerant Asthma

Active Comparator group

Description:

Patients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages

Treatment:

Dietary Supplement: Red wine

Dietary Supplement: Polyphenolic Compounds

Dietary Supplement: Water

Aspirin Intolerant Asthma / AERD

Active Comparator group

Description:

Patients with AERD who note sensitivity to alcoholic beverages

Treatment:

Dietary Supplement: Red wine

Dietary Supplement: Polyphenolic Compounds

Dietary Supplement: Water