IgE Mediated Peanut AllergyBOPI-1NCT02149719
Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study
A study testing Desensitisation using boiled peanut and Desensitisation using boiled peanut (deferred start) in people with IgE Mediated Peanut Allergy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- IgE Mediated Peanut Allergy
- What is being tested?
- Desensitisation using boiled peanut and Desensitisation using boiled peanut (deferred start)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to 12 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IgE-mediated peanut allergy, confirmed at double-blind placebo-controlled food challenge
- Tolerant to at least 1/4 boiled peanut (boiled for 4 hours) at open food challenge.
- Informed consent of parent/legal guardian and patient assent
Who cannot join
- Allergic to 1/4 boiled peanut at PCFC
- Tolerates ≥1.4 g roasted peanut protein at entry PCFC
- Unstable asthma
- Unwilling or unable to fulfil study requirements
- Undergoing other forms of immunotherapy (e.g. SCIT or SLIT to aeroallergens)
- Previous admission to ICU for management of allergic reaction to peanut
Show all 9Show fewer
- Clinically significant chronic illness (other than asthma, rhinitis or eczema).
- Undergoing subcutaneous or sublingual immunotherapy and within the first year of therapy, for respiratory allergy.
- Subjects receiving anti-IgE therapy, oral immunosupressants, beta-blocker or ACE inhibitor therapy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London / Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: Phase 2 Randomised Study of Oral Immunotherapy Using Boiled Peanut to Induce Desensitisation in Children With Challenge-proven, IgE-mediated Peanut Allergy
Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs.
Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut.
Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.
- Conditions
- IgE Mediated Peanut Allergy
- Being tested
- Desensitisation using boiled peanut, Desensitisation using boiled peanut (deferred start)
- Keywords
- Peanut allergy, Desensitisation, Safety
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desensitisation using boiled peanutOther
Desensitisation using boiled peanut (deferred start)Other
| Study group | Role | What they receive |
|---|---|---|
| Desensitisation to peanut | Experimental | Desensitisation using boiled peanut Receives: Other: Desensitisation using boiled peanut |
| Control | Experimental | Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention). Receives: Other: Desensitisation using boiled peanut (deferred start) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge
The proportion of participants who tolerate 1.4g (or more) roasted peanut protein after 12 months of OIT as assessed by DBPCFC, in the active vs control group.
Measured: 12 months
Secondary outcomes (6)
Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT
Relative change in clinical threshold (No observed adverse event level, NOAEL; Lowest observed adverse event level, LOAEL) to roasted peanut at 6 and 12 months.
Measured: 6 and 12 months after study intervention
Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT
Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.
Measured: After 1 year of OIT
Safety, Incidence of Adverse Event
Incidence of adverse allergic events during desensitisation protocol
Measured: 12 months
Quality of Life Measures
Quality of Life assessment and how this changes during peanut desensitisation.
Measured: 6, 12 and 24 months
Study Compliance
Compliance with study protocol
Measured: 12 months
Immunological Outcomes
Immunological outcome measures pre-, during and post- 12 months of OIT
Measured: Pre, 3, 6, and 12 months post start of OIT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2015
- Primary completion30 Nov 2020
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IgE Mediated Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Paul Turner, Imperial College London
- Investigators
- Dianne E Campbell, FRACP PhD, Study chair, The Children's Hospital at Westmead, AustraliaSam Mehr, FRACP, Study director, The Children's Hospital at Westmead, AustraliaPaul J Turner, FRACP PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149719
- Sponsor's protocol ID
- 15SM2492
- Other IDs
- ACTRN12614000265673
- Acronym
- BOPI-1
- Status last verified
- Mar 2024
- First submitted
- 24 May 2014
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Turner PJ, Ruiz-Garcia M, Patel N, Abrantes G, Burrell S, Vazquez-Ortiz M, Skypala I, Durham SR, Boyle RJ. Delayed symptoms and orthostatic intolerance following peanut challenge. Clin Exp Allergy. 2021 May;51(5):696-702. doi: 10.1111/cea.13865. Epub 2021 Mar 21.
PubMed 33715235Burrell S, Patel N, Vazquez-Ortiz M, Campbell DE, DunnGalvin A, Turner PJ. Self-administration of adrenaline for anaphylaxis during in-hospital food challenges improves health-related quality of life. Arch Dis Child. 2021 Jun;106(6):558-563. doi: 10.1136/archdischild-2020-319906. Epub 2020 Sep 18.
PubMed 32948514
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomised Study of Oral Immunotherapy Using Boiled Peanut to Induce Desensitisation in Children With Challenge-proven, IgE-mediated Peanut Allergy
- ClinicalTrials.gov ID
- NCT02149719
- Acronym / sponsor ID
- BOPI-1 / 15SM2492
- Conditions
- IgE Mediated Peanut Allergy
- Keywords
- Peanut allergy, Desensitisation, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Sydney, National Institute for Health Research, United Kingdom
- Study start
- May 2015 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Posted 29 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs.
Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut.
Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desensitisation to peanut | Experimental | Other: Desensitisation using boiled peanutDesensitisation using boiled peanut |
| Control | Experimental | Other: Desensitisation using boiled peanut (deferred start)Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention). |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- IgE-mediated peanut allergy, confirmed at double-blind placebo-controlled food challenge
- Tolerant to at least 1/4 boiled peanut (boiled for 4 hours) at open food challenge.
- Informed consent of parent/legal guardian and patient assent
Key exclusion criteria (9 listed)
- Allergic to 1/4 boiled peanut at PCFC
- Tolerates ≥1.4 g roasted peanut protein at entry PCFC
- Unstable asthma
- Unwilling or unable to fulfil study requirements
- Undergoing other forms of immunotherapy (e.g. SCIT or SLIT to aeroallergens)
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 |
|---|---|---|
| Desensitisation using boiled peanut | Other | Desensitisation to peanut |
| Desensitisation using boiled peanut (deferred start) | Other | Control |
Primary outcome
Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge
Time frame: 12 months
The proportion of participants who tolerate 1.4g (or more) roasted peanut protein after 12 months of OIT as assessed by DBPCFC, in the active vs control group.
6 secondary outcomes
Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT
Time frame: 6 and 12 months after study intervention
Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT
Time frame: After 1 year of OIT
Safety, Incidence of Adverse Event
Time frame: 12 months
Quality of Life Measures
Time frame: 6, 12 and 24 months
Study Compliance
Time frame: 12 months
Immunological Outcomes
Time frame: Pre, 3, 6, and 12 months post start of OIT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33715235Turner PJ, Ruiz-Garcia M, Patel N, Abrantes G, Burrell S, Vazquez-Ortiz M, Skypala I, Durham SR, Boyle RJ. Delayed symptoms and orthostatic intolerance following peanut challenge. Clin Exp Allergy. 2021 May;51(5):696-702. doi: 10.1111/cea.13865. Epub 2021 Mar 21.
- Derived from this study: PubMed 32948514Burrell S, Patel N, Vazquez-Ortiz M, Campbell DE, DunnGalvin A, Turner PJ. Self-administration of adrenaline for anaphylaxis during in-hospital food challenges improves health-related quality of life. Arch Dis Child. 2021 Jun;106(6):558-563. doi: 10.1136/archdischild-2020-319906. Epub 2020 Sep 18.
Related trials for IgE Mediated Peanut Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
Active, not recruitingPhase 1
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
Food Allergy
Active, not recruiting
Using Commonly Available Food Products To Treat Food Allergy
IgE-Mediated Cow Milk Allergy, Peanut Allergy
Active, not recruiting
Boiled Peanut Immunotherapy for the Treatment of Peanut Allergy
IgE Mediated Peanut Allergy, Peanut Hypersensitivity
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.
Dianne E Campbell, FRACP PhD study chair
The Children's Hospital at Westmead, Australia
Sam Mehr, FRACP study director
The Children's Hospital at Westmead, Australia
Paul J Turner, FRACP PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desensitisation using boiled peanut and Desensitisation using boiled peanut (deferred start) in people with IgE Mediated Peanut Allergy, run by Imperial College London at 1 site in United Kingdom.
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 3 inclusion and 9 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 29 Mar 2024. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge (time frame: 12 months). 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 NCT02149719, which also lists 2 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 29 Mar 2024.