PEAnut Anaphylaxis Predictors (PEAAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02424136|
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peanut Hypersensitivity Anaphylaxis||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||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PEAnut Anaphylaxis Predictors|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
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).
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
- Blood biomarker predicting anaphylaxis at peanut food challenge [ Time Frame: At completion of 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.
- Blood biomarker in combination with FeNO, and/or Ara h2 sIgE predicting anaphylaxis at peanut food challenge [ Time Frame: At completion of 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424136
|Contact: Joerg Mattes, MD||+61 2 email@example.com|
|Contact: Rani Bhatia, MD||+61 2 firstname.lastname@example.org|
|Australia, New South Wales|
|John Hunter Children's Hospital||Recruiting|
|New Lambton, New South Wales, Australia, 2305|
|Contact: Joerg Mattes, MD + 61 2 4985 5277 Joerg.Mattes@hnehealth.nsw.gov.au|
|Principal Investigator: Joerg Mattes, MD|
|Principal Investigator:||Joerg Mattes, MD||John Hunter Children's Hospital, Australia|