PEAnut Anaphylaxis Predictors

NCT02424136 | Completed

• 1 other identifier: PEAAP (14/12/12/4.12)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Peanut Hypersensitivity; Anaphylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood biomarker in combination with FeNO, and/or Ara h2 sIgE predicting anaphylaxis at peanut food challenge

  At completion of peanut food challenge

Study Arms (1)

Entire group

OTHER

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; 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

Interventions

Questionnaire OTHER

5 minute questionnaire focused on symptoms of allergic disease

Entire group

Peanut Skin prick test OTHER

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

Entire group

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).

Entire group

Spirometry OTHER

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

Entire group

Serum Peanut and Ara h2 specific immunoglobulin E OTHER

Peanut and Ara h2 specific IgE antibodies

Entire group

Collection of blood biomarker OTHER

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

Entire group

Peanut food challenge OTHER

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

Entire group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• John Hunter Children's Hospital: lead
• Hunter Medical Research Institute, Australia: collaborator
• University of Newcastle, Australia: collaborator
• Thrasher Research Fund: collaborator
• Hunter Childrens Research Foundation, Australia: collaborator
• Aerocrine AB: collaborator

Study Sites (1)

John Hunter Children's Hospital

New Lambton, New South Wales, 2305, Australia

Location

Related Publications (4)

• 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.

  PMID: 23195525 BACKGROUND

• 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.

  PMID: 16055882 BACKGROUND

• 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.

  PMID: 15817806 BACKGROUND

• 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.

  PMID: 32834829 DERIVED

Related Links

• ASCIA Skin prick testing for the diagnosis of allergic disease. A manual for practitioners.

MeSH Terms

Conditions

Peanut Hypersensitivity; Anaphylaxis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Joerg Mattes, MD

  John Hunter Children's Hospital, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2015
• First Posted: April 22, 2015
• Study Start: July 22, 2015
• Primary Completion: August 28, 2018
• Study Completion: December 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)