BOPI-2 Study
Research type
Research Study
Full title
Boiled Peanut Immunotherapy for the treatment of Peanut Allergy: A non-inferiority study
IRAS ID
260243
Contact name
Paul Turner
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Peanut allergy affects 1 in 30 UK children, and is the commonest cause of life-threatening allergic reactions (anaphylaxis) in this age group. Oral immunotherapy (OIT) is an emerging treatment, where small, increasing doses of allergen are used to cause “desensitisation”. However, mild allergic reactions (and occasionally, anaphylaxis) are frequent side effects, and are a limiting factor: up to 20% of participants are unable to tolerate the treatment. Furthermore, unless regular OIT doses are continued once desensitisation has been achieved, the effect is lost: fewer than 1 in 3 maintain “sustained unresponsiveness” (SU, often referred to as “tolerance”) after stopping OIT.
Immunotherapy is widely undertaken for the treatment of hay fever and allergy to insect stings, and the success of treatment is dependent on the duration of immunotherapy. We expect therefore that for food allergy, the duration of OIT may be of critical importance for achieving SU.
In the Boiled Oral Peanut Immunotherapy (BOPI) study (NCT02149719), we used boiled peanut (which is less allergenic than roasted peanut) to successfully induce desensitization, with over 50% demonstrating SU after stopping all peanut doses for 4 weeks.
We now wish to conduct a study to demonstrate that boiled peanut is at least as effective as roasted peanut flour in treating children with peanut allergy. We propose a head-head comparison of boiled peanut to peanut flour for OIT. We will also compare results to the original BOPI study, allowing us to evaluate how duration of treatment impacts upon clinical efficacy after stopping treatment. This will inform:
• as to whether ad libitum peanut consumption is feasible after OIT – arguably the most important outcome for allergic individuals and their families
• provide a unique data set relating to duration of OIT and treatment success,
• identify predictive factors to personalise OIT protocols, maximizing successful and safe patient outcomes.REC name
London - Central Research Ethics Committee
REC reference
19/LO/0406
Date of REC Opinion
5 Apr 2019
REC opinion
Favourable Opinion