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Mechanisms of Alcohol Sensitivity in AERD

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water
Red wine
Polyphenolic Compounds
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aspirin-Sensitive Asthma With Nasal Polyps focused on measuring alcohol sensitivity, red wine, aerd

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control

Aspirin Tolerant Asthma

Aspirin Intolerant Asthma / AERD

Arm Description

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

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

Patients with AERD who note sensitivity to alcoholic beverages

Outcomes

Primary Outcome Measures

24 Hour Urinary Leukotriene-E4 (LTE4)
Urine LTE4 ng/mg Cr

Secondary Outcome Measures

24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite
Urine PGD2 metabolite ng/mg Cr
Whole blood Activated Basophil Level
Proportion of activated basophils in whole blood after ingestion
Whole Blood Activated Eosinophil Level
Proportion of activated eosinophils in whole blood after ingestion
Whole Blood tryptase
Level of tryptase concentration in whole blood

Full Information

First Posted
February 15, 2018
Last Updated
May 1, 2018
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03441438
Brief Title
Mechanisms of Alcohol Sensitivity in AERD
Official Title
Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspirin-Sensitive Asthma With Nasal Polyps, Samter's Syndrome
Keywords
alcohol sensitivity, red wine, aerd

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages
Arm Title
Aspirin Tolerant Asthma
Arm Type
Active Comparator
Arm Description
Patients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages
Arm Title
Aspirin Intolerant Asthma / AERD
Arm Type
Active Comparator
Arm Description
Patients with AERD who note sensitivity to alcoholic beverages
Intervention Type
Dietary Supplement
Intervention Name(s)
Water
Intervention Description
Serum and urine markers will be obtained after drinking 5 oz of water
Intervention Type
Dietary Supplement
Intervention Name(s)
Red wine
Intervention Description
Serum and urine markers will be obtained after drinking 5 oz of water
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyphenolic Compounds
Intervention Description
Serum and urine markers will be obtained after consuming 100 mg of provinols powder
Primary Outcome Measure Information:
Title
24 Hour Urinary Leukotriene-E4 (LTE4)
Description
Urine LTE4 ng/mg Cr
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite
Description
Urine PGD2 metabolite ng/mg Cr
Time Frame
24 hour collection
Title
Whole blood Activated Basophil Level
Description
Proportion of activated basophils in whole blood after ingestion
Time Frame
2 hours after ingestion
Title
Whole Blood Activated Eosinophil Level
Description
Proportion of activated eosinophils in whole blood after ingestion
Time Frame
2 hours after ingestion
Title
Whole Blood tryptase
Description
Level of tryptase concentration in whole blood
Time Frame
2 hours after ingestion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BJ Ferrebee-Ghamandi, MHA
Phone
434-243-1558
Email
Bjf8j@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spencer C Payne, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BJ Ferrebee-Ghamandi, MHA
Phone
434-243-1558
Email
Bjf8j@hscmail.mcc.virginia.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
24607050
Citation
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.
Results Reference
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PubMed Identifier
25213072
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. No abstract available.
Results Reference
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Mechanisms of Alcohol Sensitivity in AERD

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