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

March 27, 2024 updated by: Paul Turner, Imperial College London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1NY
        • Imperial College London / Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desensitisation to peanut
Desensitisation using boiled peanut
Other: Desensitisation using boiled peanut
Experimental: Control
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).
Other: Desensitisation using boiled peanut (deferred start)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT
Time Frame: 6 and 12 months after study intervention
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.
6 and 12 months after study intervention
Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT
Time Frame: After 1 year of OIT
Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.
After 1 year of OIT
Safety, Incidence of Adverse Event
Time Frame: 12 months
Incidence of adverse allergic events during desensitisation protocol
12 months
Quality of Life Measures
Time Frame: 6, 12 and 24 months
Quality of Life assessment and how this changes during peanut desensitisation.
6, 12 and 24 months
Study Compliance
Time Frame: 12 months
Compliance with study protocol
12 months
Immunological Outcomes
Time Frame: Pre, 3, 6, and 12 months post start of OIT
Immunological outcome measures pre-, during and post- 12 months of OIT
Pre, 3, 6, and 12 months post start of OIT

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Threshold in Peanut-allergic Subjects Found to be Tolerant to Boiled Peanut at Baseline
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

University of Sydney
National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Paul J Turner, FRACP PhD, Imperial College London
  • Study Chair: Dianne E Campbell, FRACP PhD, The Children's Hospital at Westmead, Australia
  • Study Director: Sam Mehr, FRACP, The Children's Hospital at Westmead, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

May 12, 2022

Study Registration Dates

First Submitted

May 24, 2014

First Submitted That Met QC Criteria

May 24, 2014

First Posted (Estimated)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15SM2492
  • ACTRN12614000265673 (Registry Identifier: Australian New Zealand Clinical Trials Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on IgE Mediated Peanut Allergy

Clinical Trials on Desensitisation using boiled peanut

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe