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临床试验/NCT01666275
NCT01666275撤回不适用

The Metabolomics of Anaphylaxis

Massachusetts General Hospital1 个研究点 分布在 1 个国家开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change in metabolic profile of blood serum metabolites from Baseline to 1 week post-desensitization

研究概览

简要总结

Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, or drug therapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined.

Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin during challenge/desensitization is equivalent to an allergic drug reaction however we are able to evaluate these specific reactions in a controlled, clinical environment. This population of patients undergoing aspirin desensitization is ideal for studying metabolomics as serial blood sampling can be performed in patients before, during a reaction, and after aspirin desensitization, thereby allowing each patient to serve as his or her own biological control. The investigator hopes that this study of metabolomics will allow for better methods of identifying anaphylaxis in the future.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ages 18-75 with a history of aspirin anaphylaxis or a history of hypersensitivity reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for AERD.

排除标准

  • Pregnancy/breastfeeding, possibility of poor compliance, unwilling to undergo aspirin desensitization.

结局指标

主要结局

Change in metabolic profile of blood serum metabolites from Baseline to 1 week post-desensitization

时间窗: before start of aspirin desensitization, 2 hours into desensitization, at time of reaction(s) - an expected average of 6 hours into desensitization, 1 week post-desensitization

Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleena Banerji

MD, Assistant Professor of Medicine

Massachusetts General Hospital

研究点 (1)

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