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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12614000265673 | Registry Identifier | Australian New Zealand Clinical Trials Registry |
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| Name | Class |
|---|---|
| University of Sydney | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desensitisation to peanut | Experimental | Desensitisation using boiled peanut |
|
| Control | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desensitisation using boiled peanut | Other |
| ||
| Desensitisation using boiled peanut (deferred start) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dianne E Campbell, FRACP PhD | The Children's Hospital at Westmead, Australia | Study Chair |
| Sam Mehr, FRACP | The Children's Hospital at Westmead, Australia | Study Director |
| Paul J Turner, FRACP PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London / Imperial College Healthcare NHS Trust | London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33715235 | Derived | 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. | |
| 32948514 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Desensitisation to Peanut | Desensitisation using boiled peanut |
| FG001 | Control | 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). Desensitisation using boiled peanut (deferred start) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desensitisation to Peanut | Desensitisation using boiled peanut Desensitisation using boiled peanut |
| BG001 | Control | 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). Desensitisation using boiled peanut (deferred start) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
1 year (2 years in control arm)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Desensitisation to Peanut | Desensitisation using boiled peanut | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uncomplicated anaphylaxis at hospital food challenge | Immune system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction due to study intervention | Immune system disorders | Systematic Assessment | In year 1 of study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paul Turner | Imperial College London | +44 20 3312 7754 | p.turner@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2018 | Apr 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| Other |
|
Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year. |
| After 1 year of OIT |
| Safety, Incidence of Adverse Event | Incidence of adverse allergic events during desensitisation protocol | 12 months |
| Quality of Life Measures | Quality of Life assessment and how this changes during peanut desensitisation. | 6, 12 and 24 months |
| Study Compliance | Compliance with study protocol | 12 months |
| Immunological Outcomes | Immunological outcome measures pre-, during and post- 12 months of OIT | Pre, 3, 6, and 12 months post start of OIT |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Diagnosis of asthma | Count of Participants | Participants |
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| Previous anaphylaxis to peanut | Count of Participants | Participants |
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| Skin prick test to commercial peanut allergen | Median | Full Range | mm skin wheal |
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| Serum IgE to peanut | Median | Full Range | kUA/lL |
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| Serum IgE to ara h 2 | Median | Full Range | kUA/lL |
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| 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. | Not Posted | 6 and 12 months after study intervention | Participants |
| Secondary | Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT | Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year. | Not Posted | After 1 year of OIT | Participants |
| Secondary | Safety, Incidence of Adverse Event | Incidence of adverse allergic events during desensitisation protocol | Not Posted | 12 months | Participants |
| Secondary | Quality of Life Measures | Quality of Life assessment and how this changes during peanut desensitisation. | Not Posted | 6, 12 and 24 months | Participants |
| Secondary | Study Compliance | Compliance with study protocol | Not Posted | 12 months | Participants |
| Secondary | Immunological Outcomes | Immunological outcome measures pre-, during and post- 12 months of OIT | Not Posted | Pre, 3, 6, and 12 months post start of OIT | Participants |
| Other Pre-specified | 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. | Not Posted | 12 months | Participants |
| 32 |
| 17 |
| 32 |
| 32 |
| 32 |
| EG001 | Control - Avoidance Phase | 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). | 0 | 15 | 6 | 15 | 0 | 15 |
| EG002 | Control - Desensitisation Phase | Subjects allocated to the control group underwent routine care (dietary avoidance) for 12 months, following which they were offered active treatment with boiled peanut (as a one-way cross-over intervention). | 0 | 15 | 3 | 15 | 12 | 15 |
| Anaphylaxis due to dosing at home | Immune system disorders | Systematic Assessment |
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| Anaphylaxis not related to study intervention | Immune system disorders | Systematic Assessment |
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| D007154 | Immune System Diseases |