Clinical trial NCT01666288: The Metabolomics of Anaphylaxis to Immunotherapy
Official title: The Metabolomics of Anaphylaxis to Immunotherapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Anaphylaxis as a Result of Allergen or Venom Immunotherapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ages 18-75, undergoing routine outpatient subcutaneous environmental allergen and/or venom immunotherapy

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in metabolic profile of blood serum metabolites from time of allergen/ venom immunotherapy reaction to one week post-reaction
timeFrame: time of reaction to allergen or venom immunotherapy, one week post-reaction
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital - Allergy Associates
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Aleena S Banerji, MD
role: PRINCIPAL_INVESTIGATOR
References: