Mechanisms of Alcohol Sensitivity in AERD

May 1, 2018 updated by: University of Virginia

Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (ACTUAL)

February 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20382

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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