Anaphylaxis as a Result of Allergen or Venom Immunotherapy Clinical Trial
Official title:
The Metabolomics of Anaphylaxis to Immunotherapy
| NCT number | NCT01666288 |
| Other study ID # | 2012P000683 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 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 |
Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often difficult
to diagnose due to the wide heterogeneity of clinical manifestations. The inciting agent is
often difficult to pinpoint and may include food, environmental allergens in patients
undergoing allergen immunotherapy, insect stings, and medications. Evidence of allergy by
demonstration of a positive skin test to the inciting agent, is helpful only if skin testing
is available. The only diagnostic modality that is useful in the diagnosis of anaphylaxis
when IgE skin testing is not available and the inciting agent is unknown, is an elevated
serum tryptase level. However, a diagnosis of anaphylaxis can be made without a tryptase
level or if the tryptase level is normal. A simple, non-invasive test for patients with
anaphylaxis is not currently available and would be helpful to diagnose and to guide further
management options.
Patients who develop anaphylaxis to environmental allergens or venoms during routine
outpatient subcutaneous allergen or venom immunotherapy are an ideal population to study as
we are able to evaluate these specific reactions in a controlled, clinical environment.
Although anaphylaxis is uncommon, the incidence has been estimated to vary between 0.01 and 4
percent of all allergy injections. Subcutaneous allergen or venom immunotherapies are a well
established form of therapy for patients with allergic rhinitis, allergic asthma, or a
confirmed sensitivity to stinging insects. Serial blood sampling can be performed in this
group of patients during a reaction and at baseline one week after a reaction, thereby
allowing each patient to serve as his or her own biological control.
Metabolomics is the study of metabolic pathways and the unique biochemical molecules which
result from the regulatory response to physiological stressors, disease processes, drug
therapy, or allergen or venom immunotherapy. By measuring changes in metabolite
concentrations, the range of biochemical effects and therapeutic intervention can be
determined.
The investigator plans to use metabolic profiling of blood samples collected at the time of
anaphylaxis and one week after, to see if a simple, non-invasive test for patients with
anaphylaxis could be developed.
| 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: - Males and females age 18-75 who are receiving routine outpatient subcutaneous allergen and/or venom immunotherapy and who meet the World Allergy Organization (WAO) criteria for anaphylaxis (below): Has at least ONE of the following three criteria: 1. Acute onset of an illness with involvement of the skin, mucosal tissue, or both (eg, generalized urticaria, itching or flushing, swollen lips-tongue-uvula) AND AT LEAST ONE OF THE FOLLOWING: A) Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia) B) Reduced blood pressure or associated symptoms of end-organ dysfunction (eg. Hypotonia, collapse, syncope, incontinence) OR 2. Two or more of the following that occur rapidly after exposure to a known allergen for that patient A) Involvement of the skin-mucosal tissue (eg, generalized urticaria, itch-flush, swollen lips-tongue-uvula) B) Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia) C) Reduced blood pressure or associated symptoms (eg, hypotonia, collapse,, syncope, incontinence) D) Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting) OR 3. Reduced blood pressure after exposure to known allergen for that patient with systolic blood pressure of less than 90 mm Hg or greater than 30% decrease from that person's baseline Exclusion Criteria: - Pregnancy/breastfeeding or possibility of poor compliance to subcutaneous allergen or venom immunotherapy. - Does not meet the WAO criteria for anaphylaxis (above) |
| 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 time of allergen/ venom immunotherapy reaction to one week post-reaction | Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes | time of reaction to allergen or venom immunotherapy, one week post-reaction |