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.

Study Overview

• Status: Withdrawn
• Conditions: Patients With AERD Undergoing Aspirin Desensitization

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital - Allergy Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in metabolic profile of blood serum metabolites from Baseline to 1 week post-desensitization	Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes.	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Aleena S Banerji, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ACTUAL): August 14, 2018

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (ESTIMATE): August 16, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Anaphylaxis
• Other Study ID Numbers: 2012P000448