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Status unknownNCT03441438Updated May 7, 2018

Mechanisms of Alcohol Sensitivity in AERD

An interventional study of Water and Red wine in Aspirin-Sensitive Asthma With Nasal Polyps and Samter's Syndrome, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-07.

Sponsored by University of Virginia · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • alcohol sensitivity
  • red wine
  • aerd
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 60 is below the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.

Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.

Browse University of Virginia studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Control

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

    Dietary Supplement: Water · Dietary Supplement: Red wine · Dietary Supplement: Polyphenolic Compounds

  • 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 · Dietary Supplement: Red wine · Dietary Supplement: Polyphenolic Compounds

  • Active comparator
    Aspirin Intolerant Asthma / AERD

    Patients with AERD who note sensitivity to alcoholic beverages

    Dietary Supplement: Water · Dietary Supplement: Red wine · Dietary Supplement: Polyphenolic Compounds

Interventions

  • Dietary supplementWater

    Serum and urine markers will be obtained after drinking 5 oz of water

  • Dietary supplementRed wine

    Serum and urine markers will be obtained after drinking 5 oz of water

  • Dietary supplementPolyphenolic Compounds

    Serum and urine markers will be obtained after consuming 100 mg of provinols powder

06

What researchers measure

Primary outcomes

  1. 24 Hour Urinary Leukotriene-E4 (LTE4)

    Urine LTE4 ng/mg Cr

    Time frame: 24 hour

Secondary outcomes

  1. 24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite

    Urine PGD2 metabolite ng/mg Cr

    Time frame: 24 hour collection

  2. Whole blood Activated Basophil Level

    Proportion of activated basophils in whole blood after ingestion

    Time frame: 2 hours after ingestion

  3. Whole Blood Activated Eosinophil Level

    Proportion of activated eosinophils in whole blood after ingestion

    Time frame: 2 hours after ingestion

  4. Whole Blood tryptase

    Level of tryptase concentration in whole blood

    Time frame: 2 hours after ingestion

07

Study locations

1 of 1 sites recruiting
  • University of Virginia
    Charlottesville, Virginia 22908, United States
    Recruiting
08

References and documents

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. PubMed 24607050 ↗
  • 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. No abstract available. PubMed 25213072 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03441438
Lead sponsor
University of Virginia
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
May 1, 2018
Primary completion
Sep 1, 2018 (estimated)
Completion
Sep 1, 2018 (estimated)
Last update
May 7, 2018

Study contacts

BJ Ferrebee-Ghamandi, MHA
Contact
Bjf8j@hscmail.mcc.virginia.edu
434-243-1558
Spencer C Payne, MD
principal investigator · University of Virginia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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