Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT03441438

Conditions

Aspirin-Sensitive Asthma With Nasal Polyps

Samter's Syndrome

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Water

Red wine

Polyphenolic Compounds

Study Details

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.

Conditions

Aspirin-Sensitive Asthma With Nasal Polyps

Samter's Syndrome

Study ID

NCT03441438

Start date

May 1, 2018

Status verified date

May, 2018

Completion date

Sep 1, 2018

Anticipated

Primary completion date

Sep 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Control

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

active comparator: Aspirin Tolerant Asthma

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

active comparator: Aspirin Intolerant Asthma / AERD

Patients with AERD who note sensitivity to alcoholic beverages

Interventions

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

Primary outcome measure

  • 24 Hour Urinary Leukotriene-E4 (LTE4) [ Time Frame: 24 hour ]

Central Contacts and Locations

Central contacts

BJ Ferrebee-Ghamandi, MHA

434-243-1558Bjf8j@hscmail.mcc.virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

BJ Ferrebee-Ghamandi, MHA

434-243-1558Bjf8j@hscmail.mcc.virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

May 7, 2018

Last verified

May, 2018

Keywords

  • alcohol sensitivity
  • red wine
  • aerd

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2018-05-07.