PEAnut Anaphylaxis Predictors

Anaphylaxis Clinical Trial

— PEAAP  

Official title:

PEAnut Anaphylaxis Predictors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424136
• Other study ID #: PEAAP (14/12/12/4.12)
• Status: Completed
• Phase: N/A
• Start date: July 22, 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: John Hunter Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anaphylaxis
• Hypersensitivity
• Peanut Hypersensitivity
• Shock

Intervention

Other:
• Questionnaire
5 minute questionnaire focused on symptoms of allergic disease
• Peanut Skin prick test
Skin prick testing with peanut antigen, according to ASCIA Skin Prick testing manual
• 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).
• Spirometry
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
Peanut and Ara h2 specific IgE antibodies
• Collection of blood biomarker
Correlation of blood biomarker levels in patients with successful or unsuccessful peanut food challenge
• Peanut food challenge
Open label peanut challenge conducted according to ASCIA's peanut challenge protocol and PRACTALL consensus report

Locations

Country	Name	City	State
Australia	John Hunter Children's Hospital	New Lambton	New South Wales

Sponsors (6)

Lead Sponsor	Collaborator
John Hunter Children's Hospital	Aerocrine AB, Hunter Childrens Research Foundation, Australia, Hunter Medical Research Institute, Australia, Thrasher Research Fund, University of Newcastle, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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