Mechanisms of Alcohol Sensitivity in AERD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease

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

Intervention / Treatment
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* Dietary Supplement: Water
* Dietary Supplement: Red wine
* Dietary Supplement: Polyphenolic Compounds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages | Dietary Supplement: Water<br>* Serum and urine markers will be obtained after drinking 5 oz of water<br>Dietary Supplement: Red wine<br>* Serum and urine markers will be obtained after drinking 5 oz of water<br>Dietary Supplement: Polyphenolic Compounds<br>* Serum and urine markers will be obtained after consuming 100 mg of provinols powder<br>|
| Active Comparator: Aspirin Tolerant Asthma<br>Patients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages | Dietary Supplement: Water<br>* Serum and urine markers will be obtained after drinking 5 oz of water<br>Dietary Supplement: Red wine<br>* Serum and urine markers will be obtained after drinking 5 oz of water<br>Dietary Supplement: Polyphenolic Compounds<br>* Serum and urine markers will be obtained after consuming 100 mg of provinols powder<br>|
| Active Comparator: Aspirin Intolerant Asthma / AERD<br>Patients with AERD who note sensitivity to alcoholic beverages | Dietary Supplement: Water<br>* Serum and urine markers will be obtained after drinking 5 oz of water<br>Dietary Supplement: Red wine<br>* Serum and urine markers will be obtained after drinking 5 oz of water<br>Dietary Supplement: Polyphenolic Compounds<br>* Serum and urine markers will be obtained after consuming 100 mg of provinols powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 Hour Urinary Leukotriene-E4 (LTE4) | Urine LTE4 ng/mg Cr | 24 hour | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol sensitivity, red wine, aerd