Mechanisms of Alcohol Sensitivity in AERD

• Sponsor: University of Virginia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03441438
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 14.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aspirin-Sensitive Asthma With Nasal Polyps; Samter's Syndrome	Dietary Supplement: Water; Dietary Supplement: Red wine; Dietary Supplement: Polyphenolic Compounds	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease
• Actual Study Start Date: May 1, 2018
• Anticipated Primary Completion Date: Sep 1, 2018
• Anticipated Study Completion Date: Sep 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 24 Hour Urinary Leukotriene-E4 (LTE4) [24 hour]

   Urine LTE4 ng/mg Cr

Secondary Outcome Measures

1. 24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite [24 hour collection]

   Urine PGD2 metabolite ng/mg Cr

2. Whole blood Activated Basophil Level [2 hours after ingestion]

   Proportion of activated basophils in whole blood after ingestion

3. Whole Blood Activated Eosinophil Level [2 hours after ingestion]

   Proportion of activated eosinophils in whole blood after ingestion

4. Whole Blood tryptase [2 hours after ingestion]

   Level of tryptase concentration in whole blood

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• University of Virginia

Investigators

• Principal Investigator: Spencer C Payne, MD, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cardet JC, White AA, Barrett NA, Feldweg AM, Wickner PG, Savage J, Bhattacharyya N, Laidlaw TM. Alcohol-induced respiratory symptoms are common in patients with aspirin exacerbated respiratory disease. J Allergy Clin Immunol Pract. 2014 Mar-Apr;2(2):208-13.. doi: 10.1016/j.jaip.2013.12.003.
• Payne SC. Re: Alcohol-induced respiratory symptoms are common in patients with aspirin exacerbated respiratory disease. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):644. doi: 10.1016/j.jaip.2014.05.003.

• Responsible Party: University of Virginia
• ClinicalTrials.gov Identifier: NCT03441438
• Other Study ID Numbers: 20382
• First Posted: Feb 22, 2018
• Last Update Posted: May 7, 2018
• Last Verified: May 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Virginia: alcohol sensitivity; red wine; aerd
• Additional relevant MeSH terms: Nasal Polyps; Hypersensitivity

Study Results

No Results Posted as of May 7, 2018