Patients With AERD Undergoing Aspirin Desensitization Clinical Trial
Official title:
The Metabolomics of Anaphylaxis
| NCT number | NCT01666275 |
| Other study ID # | 2012P000448 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2012 |
| Est. completion date | August 14, 2018 |
| Verified date | March 2019 |
| Source | Massachusetts General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 14, 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts General Hospital - Allergy Associates | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts General Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |