Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study (BOPI-1)
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|ClinicalTrials.gov Identifier: NCT02149719|
Recruitment Status : Active, not recruiting
First Posted : May 29, 2014
Last Update Posted : March 9, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|IgE Mediated Peanut Allergy||Other: Desensitisation using boiled peanut Other: Desensitisation using boiled peanut (deferred start)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Randomised Study of Oral Immunotherapy Using Boiled Peanut to Induce Desensitisation in Children With Challenge-proven, IgE-mediated Peanut Allergy|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||March 2022|
Experimental: Desensitisation to peanut
Desensitisation using boiled peanut
Other: Desensitisation using boiled peanut
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)
- 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.
- 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.
- 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.
- Safety, incidence of adverse event [ Time Frame: 12 months ]Incidence of adverse allergic events during desensitisation protocol
- Quality of life measures [ Time Frame: 6, 12 and 24 months ]Quality of Life assessment and how this changes during peanut desensitisation.
- Study compliance [ Time Frame: 12 months ]Compliance with study protocol
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149719
|Imperial College London / Imperial College Healthcare NHS Trust|
|London, United Kingdom, W2 1NY|
|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|
|Principal Investigator:||Paul J Turner, FRACP PhD||Imperial College London|