PEAnut Anaphylaxis Predictors

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.

Conditions

• Peanut Hypersensitivity
• Anaphylaxis

Interventions

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

Sponsors & Collaborators

• Hunter Medical Research Institute, Australia

  collaborator UNKNOWN

• University of Newcastle, Australia

  collaborator OTHER

• Thrasher Research Fund

  collaborator OTHER

• Hunter Childrens Research Foundation, Australia

  collaborator UNKNOWN

• Aerocrine AB

  collaborator INDUSTRY

• John Hunter Children's Hospital

  lead OTHER

Principal Investigators

• Joerg Mattes, MD · John Hunter Children's Hospital, Australia

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-22

Primary Completion

2018-08-28

Completion

2019-12-31

Countries

• Australia

Study Locations