The Metabolomics of Anaphylaxis
This trial is active, not recruiting.
|Condition||patients with aerd undergoing aspirin desensitization|
|Sponsor||Massachusetts General Hospital|
|Start date||March 2012|
|End date||December 2017|
|Trial size||12 participants|
|Trial identifier||NCT01666275, 2012P000448|
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.
This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization.
Change in metabolic profile of blood serum metabolites from Baseline to 1 week post-desensitization
time frame: 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
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - 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. Exclusion Criteria: - Pregnancy/breastfeeding, possibility of poor compliance, unwilling to undergo aspirin desensitization.
|Official title||The Metabolomics of Anaphylaxis|
|Principal investigator||Aleena S Banerji, MD|
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