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

IgE Mediated Peanut Allergy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149719
• Other study ID #: 15SM2492
• Secondary ID: ACTRN12614000265
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 12, 2022

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 12, 2022
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• IgE Mediated Peanut Allergy
• Peanut Hypersensitivity

Intervention

Other:
• Desensitisation using boiled peanut

• Desensitisation using boiled peanut (deferred start)

Locations

Country	Name	City	State
United Kingdom	Imperial College London / Imperial College Healthcare NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	National Institute for Health Research, United Kingdom, University of Sydney

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Threshold in Peanut-allergic Subjects Found to be Tolerant to Boiled Peanut at Baseline	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
Primary	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.	12 months
Secondary	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.	6 and 12 months after study intervention
Secondary	Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT	Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.	After 1 year of OIT
Secondary	Safety, Incidence of Adverse Event	Incidence of adverse allergic events during desensitisation protocol	12 months
Secondary	Quality of Life Measures	Quality of Life assessment and how this changes during peanut desensitisation.	6, 12 and 24 months
Secondary	Study Compliance	Compliance with study protocol	12 months
Secondary	Immunological Outcomes	Immunological outcome measures pre-, during and post- 12 months of OIT	Pre, 3, 6, and 12 months post start of OIT