Mechanisms of Alcohol Sensitivity in AERD

NCT ID: NCT03441438

Last Updated: 2018-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-09-01

Brief Summary

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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

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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.

Conditions

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Aspirin-Sensitive Asthma With Nasal Polyps Samter's Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

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

Red wine

Intervention Type DIETARY_SUPPLEMENT

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

Polyphenolic Compounds

Intervention Type DIETARY_SUPPLEMENT

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

Aspirin Tolerant Asthma

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

Group Type ACTIVE_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

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

Red wine

Intervention Type DIETARY_SUPPLEMENT

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

Polyphenolic Compounds

Intervention Type DIETARY_SUPPLEMENT

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

Aspirin Intolerant Asthma / AERD

Patients with AERD who note sensitivity to alcoholic beverages

Group Type ACTIVE_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

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

Red wine

Intervention Type DIETARY_SUPPLEMENT

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

Polyphenolic Compounds

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Water

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

Intervention Type DIETARY_SUPPLEMENT

Red wine

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

Intervention Type DIETARY_SUPPLEMENT

Polyphenolic Compounds

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Spencer C Payne, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BJ Ferrebee-Ghamandi, MHA

Role: CONTACT

434-243-1558

Facility Contacts

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BJ Ferrebee-Ghamandi, MHA

Role: primary

434-243-1558

References

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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.

Reference Type BACKGROUND
PMID: 24607050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25213072 (View on PubMed)

Other Identifiers

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20382

Identifier Type: -

Identifier Source: org_study_id

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