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OpenTrials
Completed

NCT Number: NCT02424136

PEAnut Anaphylaxis Predictors

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Hunter Children's Hospital

New Lambton, New South Wales, 2305, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Questionnaire

Other

5 minute questionnaire focused on symptoms of allergic disease

Peanut Skin prick test

Other

Skin prick testing with peanut antigen, according to ASCIA Skin Prick testing manual

Fraction of exhaled nitric oxide

Other

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).

Spirometry

Other

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

Serum Peanut and Ara h2 specific immunoglobulin E

Other

Peanut and Ara h2 specific IgE antibodies

Collection of blood biomarker

Other

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

Peanut food challenge

Other

Open label peanut challenge conducted according to ASCIA's peanut challenge protocol and PRACTALL consensus report

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

John Hunter Children's Hospital

Other

Collaborators

  • Aerocrine AB
  • Hunter Childrens Research Foundation, Australia
  • Hunter Medical Research Institute, Australia
  • Thrasher Research Fund
  • University of Newcastle, Australia

Registry information

Acronym: PEAAP

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 22, 2015
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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