The Metabolomics of Anaphylaxis to Immunotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01666288
Recruitment Status : Active, not recruiting
First Posted : August 16, 2012
Last Update Posted : October 13, 2016
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital

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.

Condition or disease
Anaphylaxis as a Result of Allergen or Venom Immunotherapy

Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Metabolomics of Anaphylaxis to Immunotherapy
Study Start Date : April 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anaphylaxis
U.S. FDA Resources

IT Anaphylaxis
Blood samples will be taken from patient that develop anaphylaxis to routine outpatient allergen or venom immunotherapy.

Primary Outcome Measures :
  1. Change in metabolic profile of blood serum metabolites from time of allergen/ venom immunotherapy reaction to one week post-reaction [ Time Frame: time of reaction to allergen or venom immunotherapy, one week post-reaction ]
    Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes

Biospecimen Retention:   Samples With DNA
Plasma will be collected and retained from whole blood samples that are spun.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients ages 18-75, undergoing routine outpatient subcutaneous environmental allergen and/or venom immunotherapy

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)


    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)


  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)


  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01666288

United States, Massachusetts
Massachusetts General Hospital - Allergy Associates
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Aleena S Banerji, MD Massachusetts General Hospital

Responsible Party: Aleena Banerji, MD, Assistant Professor of Medicine, Massachusetts General Hospital Identifier: NCT01666288     History of Changes
Other Study ID Numbers: 2012P000683
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hypersensitivity, Immediate
Immune System Diseases