Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 24 Hour Urinary Leukotriene-E4 (LTE4)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Controls - must be 21 years or older
- •Aspirin Tolerant Asthma and AERD arms must note a sensitivity to alcoholic beverages
排除标准
- •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
研究组 & 干预措施
Control
Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages
干预措施: Red wine (Dietary Supplement)
Aspirin Tolerant Asthma
Patients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages
干预措施: Red wine (Dietary Supplement)
Aspirin Intolerant Asthma / AERD
Patients with AERD who note sensitivity to alcoholic beverages
干预措施: Red wine (Dietary Supplement)
Aspirin Tolerant Asthma
Patients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages
干预措施: Polyphenolic Compounds (Dietary Supplement)
Aspirin Intolerant Asthma / AERD
Patients with AERD who note sensitivity to alcoholic beverages
干预措施: Polyphenolic Compounds (Dietary Supplement)
Aspirin Intolerant Asthma / AERD
Patients with AERD who note sensitivity to alcoholic beverages
干预措施: Water (Dietary Supplement)
Aspirin Tolerant Asthma
Patients with asthma who are tolerant to aspirin and/or other NSAIDs and note sensitivity to alcoholic beverages
干预措施: Water (Dietary Supplement)
Control
Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages
干预措施: Polyphenolic Compounds (Dietary Supplement)
Control
Patients without asthma or aspirin intolerance who may or may not react to alcoholic beverages
干预措施: Water (Dietary Supplement)
结局指标
主要结局
24 Hour Urinary Leukotriene-E4 (LTE4)
时间窗: 24 hour
Urine LTE4 ng/mg Cr
次要结局
- 24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite(24 hour collection)
- Whole blood Activated Basophil Level(2 hours after ingestion)
- Whole Blood tryptase(2 hours after ingestion)
- Whole Blood Activated Eosinophil Level(2 hours after ingestion)