The Metabolomics of Anaphylaxis

Withdrawn

• Conditions: Patients With AERD Undergoing Aspirin Desensitization

• Registration Number: NCT01666275
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-16
• Primary Completion: 2017-12
• Study Completion: 2018-08-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts General Hospital - Allergy Associates; 🇺🇸 Boston, Massachusetts, United States