The Metabolomics of Anaphylaxis to Immunotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01666288
First received: August 7, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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
Anaphylaxis as a Result of Allergen or Venom Immunotherapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Metabolomics of Anaphylaxis to Immunotherapy

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: April 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
IT Anaphylaxis
Blood samples will be taken from patient that develop anaphylaxis to routine outpatient allergen or venom immunotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666288

Contacts
Contact: Autumn C Guyer, MD 617-726-3850 aguyer@partners.org
Contact: Matt A Iandoli 617-724-1714 miandoli@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital - Allergy Associates Recruiting
Boston, Massachusetts, United States, 02114
Contact: Autumn C Guyer, MD         
Principal Investigator: Aleena S Banerji, MD         
Sub-Investigator: Autumn C Guyer, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Aleena S Banerji, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Aleena Banerji, MD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01666288     History of Changes
Other Study ID Numbers: 2012P000683
Study First Received: August 7, 2012
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 30, 2014