NCT03441438Unknown不适用
Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 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
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)
研究者
研究点 (2)
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