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Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study (BOPI-1)

Primary Purpose

IgE Mediated Peanut Allergy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Desensitisation using boiled peanut
Desensitisation using boiled peanut (deferred start)
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgE Mediated Peanut Allergy focused on measuring Peanut allergy, Desensitisation, Safety

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Imperial College London / Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Desensitisation to peanut

Control

Arm Description

Desensitisation using boiled peanut

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Sustained unresponsiveness after 4 week cessation of maintenance OIT
Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.
Safety, incidence of adverse event
Incidence of adverse allergic events during desensitisation protocol
Quality of life measures
Quality of Life assessment and how this changes during peanut desensitisation.
Study compliance
Compliance with study protocol
Immunological outcomes
Immunological outcome measures pre-, during and post- 12 months of OIT

Full Information

First Posted
May 24, 2014
Last Updated
August 9, 2022
Sponsor
Imperial College London
Collaborators
University of Sydney, National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02149719
Brief Title
Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study
Acronym
BOPI-1
Official Title
Phase 2 Randomised Study of Oral Immunotherapy Using Boiled Peanut to Induce Desensitisation in Children With Challenge-proven, IgE-mediated Peanut Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imperial College London
Collaborators
University of Sydney, National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgE Mediated Peanut Allergy
Keywords
Peanut allergy, Desensitisation, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desensitisation to peanut
Arm Type
Experimental
Arm Description
Desensitisation using boiled peanut
Arm Title
Control
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Desensitisation using boiled peanut
Intervention Type
Other
Intervention Name(s)
Desensitisation using boiled peanut (deferred start)
Primary Outcome Measure Information:
Title
Desensitisation to >1.4g (roasted) peanut protein at food challenge
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in threshold to roasted peanut after 6 and 12 months of OIT
Description
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.
Time Frame
6 and 12 months after study intervention
Title
Sustained unresponsiveness after 4 week cessation of maintenance OIT
Description
Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.
Time Frame
After 1 year of OIT
Title
Safety, incidence of adverse event
Description
Incidence of adverse allergic events during desensitisation protocol
Time Frame
12 months
Title
Quality of life measures
Description
Quality of Life assessment and how this changes during peanut desensitisation.
Time Frame
6, 12 and 24 months
Title
Study compliance
Description
Compliance with study protocol
Time Frame
12 months
Title
Immunological outcomes
Description
Immunological outcome measures pre-, during and post- 12 months of OIT
Time Frame
Pre, 3, 6, and 12 months post start of OIT
Other Pre-specified Outcome Measures:
Title
Change in threshold in peanut-allergic subjects found to be tolerant to boiled peanut at baseline
Description
Change in threshold in peanut-allergic subjects found to be tolerant to boiled peanut at baseline, as determined by double-blind, placebo-controlled food challenges pre- and post- desensitisation.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianne E Campbell, FRACP PhD
Organizational Affiliation
The Children's Hospital at Westmead, Australia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sam Mehr, FRACP
Organizational Affiliation
The Children's Hospital at Westmead, Australia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul J Turner, FRACP PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London / Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33715235
Citation
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.
Results Reference
derived
PubMed Identifier
32948514
Citation
Burrell 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.
Results Reference
derived

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Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study

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