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The Metabolomics of Anaphylaxis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01666275
First received: August 7, 2012
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Patients With AERD Undergoing Aspirin Desensitization

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Metabolomics of Anaphylaxis

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 12
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aspirin desensitization
This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Aleena Banerji, MD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01666275     History of Changes
Other Study ID Numbers: 2012P000448
Study First Received: August 7, 2012
Last Updated: August 10, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013