The Metabolomics of Anaphylaxis to Immunotherapy

March 5, 2019 updated by: Aleena Banerji, Massachusetts General Hospital

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.

Study Overview

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital - Allergy Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients ages 18-75, undergoing routine outpatient subcutaneous environmental allergen and/or venom immunotherapy

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
time of reaction to allergen or venom immunotherapy, one week post-reaction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aleena S Banerji, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ACTUAL)

August 14, 2018

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (ESTIMATE)

August 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2012P000683

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anaphylaxis as a Result of Allergen or Venom Immunotherapy

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