The Metabolomics of Anaphylaxis
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.
Patients With AERD Undergoing Aspirin Desensitization
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||The Metabolomics of Anaphylaxis|
- 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 ] [ Designated as safety issue: No ]Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes.
Biospecimen Retention: Samples With DNA
We retain and freeze the plasma from blood after spinning down whole-blood samples.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666275
|Contact: Autumn C Guyer, MDemail@example.com|
|Contact: Matt A Iandolifirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital - Allergy Associates||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Autumn C Guyer, MD|
|Principal Investigator: Aleena S Banerji, MD|
|Sub-Investigator: Autumn C Guyer, MD|
|Principal Investigator:||Aleena S Banerji, MD||Massachusetts General Hospital|