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PEAnut Anaphylaxis Predictors (PEAAP)

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ClinicalTrials.gov Identifier: NCT02424136
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
Hunter Medical Research Institute, Australia
University of Newcastle, Australia
Thrasher Research Fund
Hunter Childrens Research Foundation, Australia
Aerocrine AB
Information provided by (Responsible Party):
John Hunter Children's Hospital

Brief Summary:
Peanut allergy can be life-threatening. Current diagnostic techniques for peanut allergy have high sensitivity, but not high specificity. This clinical trial will test the validity of a novel blood biomarker (compared with current testing) as a diagnostic predictor of anaphylaxis to peanut.

Condition or disease Intervention/treatment Phase
Peanut Hypersensitivity Anaphylaxis Other: Questionnaire Other: Peanut Skin prick test Other: Fraction of exhaled nitric oxide Other: Spirometry Other: Serum Peanut and Ara h2 specific immunoglobulin E Other: Collection of blood biomarker Other: Peanut food challenge Not Applicable

Detailed Description:

Children aged 2-17 years with suspected peanut allergy will be invited to participate in the study.

They will have a questionnaire, a skin prick test to peanut, 2 breathing tests (spirometry and fraction of exhaled nitric oxide (FeNO)), and a blood test (specific peanut antibodies, allergic immune responses - including the novel blood biomarker - and genetic testing to identify novel potential molecular and genetic markers of food allergy in the future. The genetic testing component will be optional). The breathing test is not required for those under 6 years.

The final step is an open label peanut food challenge with incremental doses of peanut, (routine practise) as per the Australasian Society of Clinical Immunology and Allergy (ASCIA) food challenge protocol.The endpoints in the food challenge will be signs of allergy or anaphylaxis as per PRACTicing ALLergology (PRACTALL) consensus report for oral food challenges OR completion of the ASCIA food challenge protocol.

Outcome: The primary outcome of the project is to confirm that a novel blood biomarker has a higher diagnostic accuracy as compared to current best testing in predicting anaphylaxis at open label peanut challenge.

Secondary outcome: Will be to determine the value of the biomarker, FeNO and Ara h2 specific Immunoglobulin E (sIgE) (individually and in combination) at predicting anaphylaxis or clinical allergy at open label peanut challenge.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PEAnut Anaphylaxis Predictors
Study Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Anaphylaxis

Arm Intervention/treatment
Entire group
Children aged 2-17 years with suspected peanut allergy who require peanut food challenge to confirm clinical allergy, will be recruited for the study. They will undergo a preceding questionnaire, peanut skin prick testing, spirometry, fraction of exhaled nitric oxide (FeNO) measurement, serum peanut and Ara h2 specific immunoglobulin E (sIgE) antibodies, and collection of blood biomarker prior to food challenge. The primary endpoint will be anaphylaxis at open label peanut challenge, with the primary exposure of interest will be the serum biomarker.
Other: Questionnaire
5 minute questionnaire focused on symptoms of allergic disease

Other: Peanut Skin prick test
Skin prick testing with peanut antigen, according to ASCIA Skin Prick testing manual

Other: Fraction of exhaled nitric oxide
Measurement of exhaled nitric oxide, according to American Thoracic Society/ European Thoracic Society (ATS/ERS) standardised procedures (Not required for those age less than 6 years).

Other: Spirometry
Measurement of lung flows/volumes, according to ATS/ERS standardised procedures (Not required for those age less than 6 years).

Other: Serum Peanut and Ara h2 specific immunoglobulin E
Peanut and Ara h2 specific IgE antibodies

Other: Collection of blood biomarker
Correlation of blood biomarker levels in patients with successful or unsuccessful peanut food challenge

Other: Peanut food challenge
Open label peanut challenge conducted according to ASCIA's peanut challenge protocol and PRACTALL consensus report




Primary Outcome Measures :
  1. Blood biomarker predicting anaphylaxis at peanut food challenge [ Time Frame: At completion of peanut food challenge ]
    The primary outcome of the project is to confirm that a novel blood biomarker has a higher diagnostic accuracy as compared to current best testing in predicting anaphylaxis at open label peanut challenge.


Secondary Outcome Measures :
  1. Blood biomarker in combination with FeNO, and/or Ara h2 sIgE predicting anaphylaxis at peanut food challenge [ Time Frame: At completion of peanut food challenge ]
    The secondary outcome will be to determine the value of the biomarker, FeNO and Ara h2 sIgE (individually and in combination) at predicting anaphylaxis or clinical allergy at open label peanut challenge.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 2 - 17 years with an allergy to peanut and require peanut challenge to confirm peanut allergy.

Exclusion Criteria:

  • Children with Peanut Skin Prick Test (SPT) wheal size greater than 10mm as these children are likely to have clinical peanut allergy (no clinical indication for food challenge).

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 ClinicalTrials.gov identifier (NCT number): NCT02424136


Contacts
Contact: Joerg Mattes, MD +61 2 49855277 joerg.mattes@hnehealth.nsw.gov.au
Contact: Rani Bhatia, MD +61 2 49213676 rani.bhatia@hnehealth.nsw.gov.au

Locations
Australia, New South Wales
John Hunter Children's Hospital Recruiting
New Lambton, New South Wales, Australia, 2305
Contact: Joerg Mattes, MD    + 61 2 4985 5277    Joerg.Mattes@hnehealth.nsw.gov.au   
Principal Investigator: Joerg Mattes, MD         
Sponsors and Collaborators
John Hunter Children's Hospital
Hunter Medical Research Institute, Australia
University of Newcastle, Australia
Thrasher Research Fund
Hunter Childrens Research Foundation, Australia
Aerocrine AB
Investigators
Principal Investigator: Joerg Mattes, MD John Hunter Children's Hospital, Australia

Additional Information:
Publications:
Responsible Party: John Hunter Children's Hospital
ClinicalTrials.gov Identifier: NCT02424136     History of Changes
Other Study ID Numbers: PEAAP (14/12/12/4.12)
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Anaphylaxis
Peanut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Immunoglobulins
Antibodies
Nitric Oxide
Immunologic Factors
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents