Mechanisms of Alcohol Sensitivity in AERD

Aspirin-Sensitive Asthma With Nasal Polyps Clinical Trial

Official title:

Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03441438
• Other study ID #: 20382
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: May 2018
• Source: University of Virginia
• Contact: BJ Ferrebee-Ghamandi, MHA
• Phone: 434-243-1558
• Email: Bjf8j[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspirin-Sensitive Asthma With Nasal Polyps
• Hypersensitivity
• Nasal Polyps
• Samter's Syndrome

Intervention

Dietary Supplement:
• Water
Serum and urine markers will be obtained after drinking 5 oz of water
• Red wine
Serum and urine markers will be obtained after drinking 5 oz of water
• Polyphenolic Compounds
Serum and urine markers will be obtained after consuming 100 mg of provinols powder

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 Hour Urinary Leukotriene-E4 (LTE4)	Urine LTE4 ng/mg Cr	24 hour
Secondary	24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite	Urine PGD2 metabolite ng/mg Cr	24 hour collection
Secondary	Whole blood Activated Basophil Level	Proportion of activated basophils in whole blood after ingestion	2 hours after ingestion
Secondary	Whole Blood Activated Eosinophil Level	Proportion of activated eosinophils in whole blood after ingestion	2 hours after ingestion
Secondary	Whole Blood tryptase	Level of tryptase concentration in whole blood	2 hours after ingestion