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

Imperial College London

Status: Completed

Conditions: IgE Mediated Peanut Allergy

Treatments: Other: Desensitisation using boiled peanut; Other: Desensitisation using boiled peanut (deferred start)

Study type: Interventional

Funder types: Other

Identifiers

NCT02149719

15SM2492

ACTRN12614000265673 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Desensitisation to peanut

Experimental group

Description:

Desensitisation using boiled peanut

Treatment:

Other: Desensitisation using boiled peanut

Control

Experimental group

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).

Treatment:

Other: Desensitisation using boiled peanut (deferred start)