CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Questionnaire +6 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02424136
NCT02424136N/ACompleted
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PEAnut Anaphylaxis Predictors

John Hunter Children's Hospital·interventional·Posted Apr 22, 2015·Updated Jan 22, 2020

In Brief

A clinical study evaluating Questionnaire, Peanut Skin prick test, and 5 other interventions for Peanut Hypersensitivity and Anaphylaxis. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Hypersensitivity, Anaphylaxis
CountriesAustralia
CollaboratorsHunter Medical Research Institute, Australia, University of Newcastle, Australia, Thrasher Research Fund, Hunter Childrens Research Foundation, Australia, Aerocrine AB

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 22, 2015
Enrollment StartJul 22, 2015
Primary CompletionAug 28, 2018
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.2 years ago

Interventions

Questionnaireother

5 minute questionnaire focused on symptoms of allergic disease

Peanut Skin prick testother

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

Fraction of exhaled nitric oxideother

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).

Spirometryother

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 Eother

Peanut and Ara h2 specific IgE antibodies

Collection of blood biomarkerother

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

Peanut food challengeother

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