Clinical trial NCT02149719: Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study
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
Overall status: COMPLETED
Phase: NA
Conditions: IgE Mediated Peanut Allergy
Keywords: Peanut allergy
Desensitisation
Safety
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: National Institute for Health Research, United Kingdom
First posted: 2014-05-29
Enrollment: 47
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge
timeFrame: 12 months
Secondary outcomes:
measure: Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT
timeFrame: 6 and 12 months after study intervention
measure: Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT
timeFrame: After 1 year of OIT
measure: Safety, Incidence of Adverse Event
timeFrame: 12 months
measure: Quality of Life Measures
timeFrame: 6, 12 and 24 months
measure: Study Compliance
timeFrame: 12 months
measure: Immunological Outcomes
timeFrame: Pre, 3, 6, and 12 months post start of OIT
Other outcomes:
measure: Change in Threshold in Peanut-allergic Subjects Found to be Tolerant to Boiled Peanut at Baseline
timeFrame: 12 months
Locations:
city: London
country: United Kingdom
facility: Imperial College London / Imperial College Healthcare NHS Trust
Study officials:
affiliation: The Children's Hospital at Westmead, Australia
name: Dianne E Campbell, FRACP PhD
role: STUDY_CHAIR
affiliation: The Children's Hospital at Westmead, Australia
name: Sam Mehr, FRACP
role: STUDY_DIRECTOR
affiliation: Imperial College London
name: Paul J Turner, FRACP PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.