The Metabolomics of Anaphylaxis
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|ClinicalTrials.gov Identifier: NCT01666275|
Recruitment Status : Active, not recruiting
First Posted : August 16, 2012
Last Update Posted : October 13, 2016
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.
|Condition or disease|
|Patients With AERD Undergoing Aspirin Desensitization|
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|Official Title:||The Metabolomics of Anaphylaxis|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
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 ]Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666275
|United States, Massachusetts|
|Massachusetts General Hospital - Allergy Associates|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Aleena S Banerji, MD||Massachusetts General Hospital|