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Mechanisms of Alcohol Sensitivity in AERD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03441438
Recruitment Status : Unknown
Verified May 2018 by University of Virginia.
Recruitment status was:  Recruiting
First Posted : February 22, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Virginia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aspirin-Sensitive Asthma With Nasal Polyps Samter's Syndrome Dietary Supplement: Water Dietary Supplement: Red wine Dietary Supplement: Polyphenolic Compounds Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 24 Hour Urinary Leukotriene-E4 (LTE4) [ Time Frame: 24 hour ]
    Urine LTE4 ng/mg Cr


Secondary Outcome Measures :
  1. 24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite [ Time Frame: 24 hour collection ]
    Urine PGD2 metabolite ng/mg Cr

  2. Whole blood Activated Basophil Level [ Time Frame: 2 hours after ingestion ]
    Proportion of activated basophils in whole blood after ingestion

  3. Whole Blood Activated Eosinophil Level [ Time Frame: 2 hours after ingestion ]
    Proportion of activated eosinophils in whole blood after ingestion

  4. Whole Blood tryptase [ Time Frame: 2 hours after ingestion ]
    Level of tryptase concentration in whole blood


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441438


Contacts
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Contact: BJ Ferrebee-Ghamandi, MHA 434-243-1558 Bjf8j@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: BJ Ferrebee-Ghamandi, MHA    434-243-1558    Bjf8j@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Spencer C Payne, MD University of Virginia
More Information
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Publications:

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Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT03441438    
Other Study ID Numbers: 20382
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Virginia:
alcohol sensitivity
red wine
aerd
Additional relevant MeSH terms:
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Nasal Polyps
Hypersensitivity
Immune System Diseases
Nose Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical