Aspirin-Sensitive Asthma With Nasal PolypsNCT03441438
Mechanisms of Alcohol Sensitivity in AERD
A study testing Water, Red wine and Polyphenolic Compounds in people with Aspirin-Sensitive Asthma With Nasal Polyps and Samter's Syndrome, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aspirin-Sensitive Asthma With Nasal Polyps, Samter's Syndrome
- What is being tested?
- Water, Red wine and Polyphenolic Compounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Controls - must be 21 years or older
- Aspirin Tolerant Asthma and AERD arms must note a sensitivity to alcoholic beverages
Who cannot join
- Enzymopathies
- Mastocytosis
- Alcoholism
- Prior severe respiratory reaction to alcohol consumption
- Current pregnancy
- Monoamine Oxidase Inhibitor (MAOI) use
Show all 9Show fewer
- Age under 21
- Use of leukotriene modifier 1 week before study intervention
- Having undergone and maintained aspirin desensitization
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
BJ Ferrebee-Ghamandi, MHA, 434-243-1558, Bjf8j@hscmail.mcc.virginia.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Water, Red wine, Polyphenolic Compounds
- Keywords
- alcohol sensitivity, red wine, aerd
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterDietary supplement
Serum and urine markers will be obtained after drinking 5 oz of water
Red wineDietary supplement
Serum and urine markers will be obtained after drinking 5 oz of water
Polyphenolic CompoundsDietary supplement
Serum and urine markers will be obtained after consuming 100 mg of provinols powder
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages Receives: Dietary Supplement: Water; Dietary Supplement: Red wine; Dietary 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 Receives: Dietary Supplement: Water; Dietary Supplement: Red wine; Dietary Supplement: Polyphenolic Compounds |
| Aspirin Intolerant Asthma / AERD | Active comparator | Patients with AERD who note sensitivity to alcoholic beverages Receives: Dietary Supplement: Water; Dietary Supplement: Red wine; Dietary Supplement: Polyphenolic Compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour Urinary Leukotriene-E4 (LTE4)
Urine LTE4 ng/mg Cr
Measured: 24 hour
Secondary outcomes (4)
24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite
Urine PGD2 metabolite ng/mg Cr
Measured: 24 hour collection
Whole blood Activated Basophil Level
Proportion of activated basophils in whole blood after ingestion
Measured: 2 hours after ingestion
Whole Blood Activated Eosinophil Level
Proportion of activated eosinophils in whole blood after ingestion
Measured: 2 hours after ingestion
Whole Blood tryptase
Level of tryptase concentration in whole blood
Measured: 2 hours after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 May 2018
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aspirin-Sensitive Asthma With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Spencer C Payne, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441438
- Sponsor's protocol ID
- 20382
- Status last verified
- May 2018
- First submitted
- 15 Feb 2018
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24607050Payne 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.
PubMed 25213072
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease
- ClinicalTrials.gov ID
- NCT03441438
- Acronym / sponsor ID
- 20382
- Keywords
- alcohol sensitivity, red wine, aerd
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Dietary Supplement: Water, Dietary Supplement: Red wine, Dietary Supplement: Polyphenolic CompoundsPatients without asthma or aspirin intolerance who may or may not react to alcoholic beverages |
| Aspirin Tolerant Asthma | Active comparator | Dietary Supplement: Water, Dietary Supplement: Red wine, Dietary Supplement: Polyphenolic CompoundsPatients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages |
| Aspirin Intolerant Asthma / AERD | Active comparator | Dietary Supplement: Water, Dietary Supplement: Red wine, Dietary Supplement: Polyphenolic CompoundsPatients with AERD who note sensitivity to alcoholic beverages |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Controls - must be 21 years or older
- Aspirin Tolerant Asthma and AERD arms must note a sensitivity to alcoholic beverages
Key exclusion criteria (9 listed)
- Enzymopathies
- Mastocytosis
- Alcoholism
- Prior severe respiratory reaction to alcohol consumption
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterSerum and urine markers will be obtained after drinking 5 oz of water | Dietary supplement | Aspirin Intolerant Asthma / AERD, Aspirin Tolerant Asthma, Control |
| Red wineSerum and urine markers will be obtained after drinking 5 oz of water | Dietary supplement | Aspirin Intolerant Asthma / AERD, Aspirin Tolerant Asthma, Control |
| Polyphenolic CompoundsSerum and urine markers will be obtained after consuming 100 mg of provinols powder | Dietary supplement | Aspirin Intolerant Asthma / AERD, Aspirin Tolerant Asthma, Control |
Primary outcome
24 Hour Urinary Leukotriene-E4 (LTE4)
Time frame: 24 hour
Urine LTE4 ng/mg Cr
4 secondary outcomes
24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite
Time frame: 24 hour collection
Whole blood Activated Basophil Level
Time frame: 2 hours after ingestion
Whole Blood Activated Eosinophil Level
Time frame: 2 hours after ingestion
Whole Blood tryptase
Time frame: 2 hours after ingestion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Background: PubMed 24607050Cardet 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.
- Background: PubMed 25213072Payne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spencer C Payne, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water, Red wine and Polyphenolic Compounds in people with Aspirin-Sensitive Asthma With Nasal Polyps and Samter's Syndrome, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BJ Ferrebee-Ghamandi, MHA (434-243-1558, Bjf8j@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 Hour Urinary Leukotriene-E4 (LTE4) (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03441438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.