Peanut HypersensitivityPEAAPNCT02424136

PEAnut Anaphylaxis Predictors

A study testing Questionnaire, Peanut Skin prick test and Fraction of exhaled nitric oxide in people with Peanut Hypersensitivity and Anaphylaxis, run by John Hunter Children's Hospital at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Peanut Hypersensitivity, Anaphylaxis
What is being tested?: Questionnaire, Peanut Skin prick test and Fraction of exhaled nitric oxide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteAustralia
Study dates: 22 Jul 2015to Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Australia1 site

John Hunter Children's Hospital
New Lambton, New South Wales, 2305

Other trials in Australia

About this study

Read the detailed 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.

Conditions: Peanut Hypersensitivity, Anaphylaxis
Being tested: Questionnaire, Peanut Skin prick test, Fraction of exhaled nitric oxide, Spirometry, Serum Peanut and Ara h2 specific immunoglobulin E
Medical subject headings: Peanut Hypersensitivity, Anaphylaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02424136
Study group	Role	What they receive
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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: At completion of peanut food challenge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 2015Dec 2019

First posted22 Apr 2015 (estimated)
Study start22 Jul 2015
Primary completion28 Aug 2018
Study completionDec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Peanut HypersensitivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02424136
Sponsor's protocol ID: PEAAP (14/12/12/4.12)
Acronym: PEAAP
Status last verified: Jan 2020
First submitted: 19 Apr 2015
Last updated: 22 Jan 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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.
PubMed 23195525
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.
PubMed 16055882
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.
PubMed 15817806
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.
PubMed 32834829

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
Peanut Allergy
Not yet recruitingPhase 2
UNC Cashew Sublingual Immunotherapy
Cashew Nut Allergy, Tree Nut Allergies

All Peanut Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PEAnut Anaphylaxis Predictors
ClinicalTrials.gov ID: NCT02424136
Acronym / sponsor ID: PEAAP / PEAAP (14/12/12/4.12)
Conditions: Peanut Hypersensitivity, Anaphylaxis
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: John Hunter Children's HospitalUniversity, hospital or other
Collaborators: Hunter Medical Research Institute, Australia, University of Newcastle, Australia, Thrasher Research Fund, Hunter Childrens Research Foundation, Australia, Aerocrine AB
Study start: 22 Jul 2015 (actual)
Primary completion: 28 Aug 2018 (actual)
Study completion: Dec 2019 (actual)
First posted: 22 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Children aged 2-17 years with suspected peanut allergy will be invited to participate in the study.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Entire group	Other	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 challengeChildren 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.

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Questionnaire5 minute questionnaire focused on symptoms of allergic disease	Other	Entire group
Peanut Skin prick testSkin prick testing with peanut antigen, according to ASCIA Skin Prick testing manual	Other	Entire group
Fraction of exhaled nitric oxideMeasurement 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	Entire group
SpirometryMeasurement of lung flows/volumes, according to ATS/ERS standardised procedures (Not required for those age less than 6 years).	Other	Entire group
Serum Peanut and Ara h2 specific immunoglobulin EPeanut and Ara h2 specific IgE antibodies	Other	Entire group
Collection of blood biomarkerCorrelation of blood biomarker levels in patients with successful or unsuccessful peanut food challenge	Other	Entire group
Peanut food challengeOpen label peanut challenge conducted according to ASCIA's peanut challenge protocol and PRACTALL consensus report	Other	Entire group

Primary outcome

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.

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
Background: PubMed 23195525Sampson 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.
Background: PubMed 16055882Miller 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.
Background: PubMed 15817806American 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.
Derived from this study: PubMed 32834829Percival 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.
ASCIA Food Challenge Protocols - PeanutLink provided by the sponsor.
ASCIA Skin prick testing for the diagnosis of allergic disease. A manual for practitioners.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Peanut Hypersensitivity

Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
Peanut Allergy
Not yet recruitingPhase 2
UNC Cashew Sublingual Immunotherapy
Cashew Nut Allergy, Tree Nut Allergies

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joerg Mattes, MD principal investigator

John Hunter Children's Hospital, Australia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood biomarker predicting anaphylaxis at peanut food challenge (time frame: At completion of peanut food challenge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02424136, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.