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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
Sponsor:
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital

Brief Summary:

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
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Metabolomics of Anaphylaxis
Study Start Date : March 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anaphylaxis
U.S. FDA Resources

Group/Cohort
Aspirin desensitization
This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization.



Primary Outcome Measures :
  1. 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
We retain and freeze the plasma from blood after spinning down whole-blood samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients ages 18-75, history of an allergic reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for aspirin exacerbated respiratory disease (AERD)
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Massachusetts General Hospital - Allergy Associates
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Aleena S Banerji, MD Massachusetts General Hospital

Responsible Party: Aleena Banerji, MD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01666275     History of Changes
Other Study ID Numbers: 2012P000448
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases