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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02424136




Registration number
NCT02424136
Ethics application status
Date submitted
19/04/2015
Date registered
22/04/2015
Date last updated
22/01/2020

Titles & IDs
Public title
PEAnut Anaphylaxis Predictors
Scientific title
PEAnut Anaphylaxis Predictors
Secondary ID [1] 0 0
PEAAP (14/12/12/4.12)
Universal Trial Number (UTN)
Trial acronym
PEAAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut Hypersensitivity 0 0
Anaphylaxis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Questionnaire
Other interventions - Peanut Skin prick test
Other interventions - Fraction of exhaled nitric oxide
Other interventions - Spirometry
Other interventions - Serum Peanut and Ara h2 specific immunoglobulin E
Other interventions - Collection of blood biomarker
Other interventions - Peanut food challenge

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 interventions: Questionnaire
5 minute questionnaire focused on symptoms of allergic disease

Other interventions: Peanut Skin prick test
Skin prick testing with peanut antigen, according to ASCIA Skin Prick testing manual

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

Other interventions: Serum Peanut and Ara h2 specific immunoglobulin E
Peanut and Ara h2 specific IgE antibodies

Other interventions: Collection of blood biomarker
Correlation of blood biomarker levels in patients with successful or unsuccessful peanut food challenge

Other interventions: Peanut food challenge
Open label peanut challenge conducted according to ASCIA's peanut challenge protocol and PRACTALL consensus report
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Blood biomarker predicting anaphylaxis at peanut food challenge
Timepoint [1] 0 0
At completion of peanut food challenge
Secondary outcome [1] 0 0
Blood biomarker in combination with FeNO, and/or Ara h2 sIgE predicting anaphylaxis at peanut food challenge
Timepoint [1] 0 0
At completion of peanut food challenge

Eligibility
Key inclusion criteria
* Children aged 2 - 17 years with an allergy to peanut and require peanut challenge to confirm peanut allergy.
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2019
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 0 0
2305 - New Lambton

Funding & Sponsors
Primary sponsor type
Other
Name
John Hunter Children's Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Hunter Medical Research Institute, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Newcastle, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Thrasher Research Fund
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Hunter Childrens Research Foundation, Australia
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/industry
Name [5] 0 0
Aerocrine AB
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02424136
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Joerg Mattes, MD
Address 0 0
John Hunter Children's Hospital, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02424136