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The Metabolomics of Anaphylaxis

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01666275
Collaborator
(none)
0
Enrollment
1
Location
77.4
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Metabolomics of Anaphylaxis
    Study Start Date :
    Mar 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2017
    Actual Study Completion Date :
    Aug 14, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Aspirin desensitization

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in metabolic profile of blood serum metabolites from Baseline to 1 week post-desensitization [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aleena Banerji, MD, Assistant Professor of Medicine, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT01666275
    Other Study ID Numbers:
    • 2012P000448
    First Posted:
    Aug 16, 2012
    Last Update Posted:
    Mar 7, 2019
    Last Verified:
    Mar 1, 2019
    Additional relevant MeSH terms:
    Anaphylaxis

    Study Results

    No Results Posted as of Mar 7, 2019