This trial is active, not recruiting.

Condition patients with aerd undergoing aspirin desensitization
Sponsor Massachusetts General Hospital
Start date March 2012
End date December 2017
Trial size 12 participants
Trial identifier NCT01666275, 2012P000448


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization.

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title The Metabolomics of Anaphylaxis
Principal investigator Aleena S Banerji, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.