NCT03441438

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

February 15, 2018

Last Update Submit

May 1, 2018

Conditions

Aspirin-Sensitive Asthma With Nasal PolypsSamter's Syndrome

Keywords

alcohol sensitivityred wineaerd

Outcome Measures

Primary Outcomes (1)

  • 24 Hour Urinary Leukotriene-E4 (LTE4)

    Urine LTE4 ng/mg Cr

    24 hour

Secondary Outcomes (4)

  • 24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite

    24 hour collection

  • Whole blood Activated Basophil Level

    2 hours after ingestion

  • Whole Blood Activated Eosinophil Level

    2 hours after ingestion

  • Whole Blood tryptase

    2 hours after ingestion

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Dietary Supplement: WaterDietary Supplement: Red wineDietary Supplement: Polyphenolic Compounds

Aspirin Tolerant Asthma

ACTIVE COMPARATOR

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

Dietary Supplement: WaterDietary Supplement: Red wineDietary Supplement: Polyphenolic Compounds

Aspirin Intolerant Asthma / AERD

ACTIVE COMPARATOR

Patients with AERD who note sensitivity to alcoholic beverages

Dietary Supplement: WaterDietary Supplement: Red wineDietary Supplement: Polyphenolic Compounds

Interventions

WaterDIETARY_SUPPLEMENT

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

Aspirin Intolerant Asthma / AERDAspirin Tolerant AsthmaControl
Red wineDIETARY_SUPPLEMENT

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

Aspirin Intolerant Asthma / AERDAspirin Tolerant AsthmaControl
Polyphenolic CompoundsDIETARY_SUPPLEMENT

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

Aspirin Intolerant Asthma / AERDAspirin Tolerant AsthmaControl

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Controls - must be 21 years or older
  • Aspirin Tolerant Asthma and AERD arms must note a sensitivity to alcoholic beverages

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 24607050BACKGROUND

  • 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.

    PMID: 25213072BACKGROUND

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Spencer C Payne, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BJ Ferrebee-Ghamandi, MHA

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 22, 2018

Study Start

May 1, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations

US(1)