PEAnut Anaphylaxis Predictors (PEAAP)

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.

Study Overview

• Status: Completed
• Conditions: Peanut Hypersensitivity; Anaphylaxis
• Intervention / Treatment: 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

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
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton, New South Wales, Australia, 2305
      • John Hunter Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood biomarker predicting anaphylaxis at 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.	At completion of peanut food challenge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood biomarker in combination with FeNO, and/or Ara h2 sIgE predicting anaphylaxis at 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.	At completion of peanut food challenge

Collaborators and Investigators

• Sponsor: John Hunter Children's Hospital
• Collaborators: Thrasher Research Fund; Aerocrine AB; University of Newcastle, Australia; Hunter Medical Research Institute, Australia; Hunter Childrens Research Foundation, Australia
• Investigators: Principal Investigator: Joerg Mattes, MD, John Hunter Children's Hospital, Australia

Publications and helpful links

General Publications

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
• Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
• American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
• Percival E, Bhatia R, Preece K, McEvoy M, Collison A, Mattes J. Change in exhaled nitric oxide during peanut challenge is related to severity of reaction. Allergy Asthma Clin Immunol. 2020 Jul 21;16:64. doi: 10.1186/s13223-020-00464-8. eCollection 2020.

Helpful Links

• ASCIA Food Challenge Protocols - Peanut
• ASCIA Skin prick testing for the diagnosis of allergic disease. A manual for practitioners.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2015
• Primary Completion (Actual): August 28, 2018
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: April 19, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Shock; Peanut Hypersensitivity; Anaphylaxis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Immunologic Factors; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; Nitric Oxide
• Other Study ID Numbers: PEAAP (14/12/12/4.12)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO