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Trial registered on ANZCTR


Registration number
ACTRN12614000265673
Ethics application status
Not yet submitted
Date submitted
5/03/2014
Date registered
11/03/2014
Date last updated
11/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Boiled peanut oral immunotherapy for the treatment of peanut allergy
Scientific title
A randomised trial of boiled peanut immunotherapy for desensitisation to roasted peanut in children with challenge proven peanut allergy.
Secondary ID [1] 284206 0
nil
Universal Trial Number (UTN)
U1111-1154-1188
Trial acronym
BOPI
(boiled oral peanut immunotherapy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peanut allergy 291312 0
Condition category
Condition code
Inflammatory and Immune System 291666 291666 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following double blind oral food challenges (DPBPFC) to boiled and roasted peanut and placebo, peanut allergic children aged 5-16 years will undergo randomisation to 3 arms of 12 months of treatment with 1. Increasing doses of boiled peanut daily commencing at 0.5 grams. 2. Increasing doses of roasted peanut daily commencing at 0.5 gram.
For arms 1 and 2- Induction phase with updosing over 6 months and further 6 months maintenance (8g) daily. Updosing under supervision. Peanut preparations suppled to parents for daily home administration between updosing and during maintenance. Compliance by daily diary.
Arm 3. No treatment (delayed start) to cross over at 12 months to boiled peanut OIT as per arm 1 following further DBPCFC.
Children roasted allergic/boiled tolerant will proceed directly to daily boiled peanut maintenance at 8g over 12 months.
Intervention code [1] 288903 0
Treatment: Other
Comparator / control treatment
Boiled peanut oral immunotherapy (OIT) will be compared with standard roasted peanut OIT and no treatment. Those children randomised to no treatment will cross over and receive boiled peanut immunotherapy at 12 months. Roasted OIT is considered current standard OIT.
Control group
Active

Outcomes
Primary outcome [1] 291600 0
Change in threshold dose of roasted peanut at double blind placebo controleld oral food challenge
Timepoint [1] 291600 0
12 months
Secondary outcome [1] 307150 0
Change in threshold dose of roasted peanut at double blind placebo controlled oral food challenge
Timepoint [1] 307150 0
13.5 months- following cessation of daily maintenance oral immunotherapy for 6 weeks
Secondary outcome [2] 307151 0
Change in peanut allergen component specific IgE binding- by immunoblot fusing patient serum.
Timepoint [2] 307151 0
12 months, 13.5 months
Secondary outcome [3] 307152 0
side effects: any allergic reactions during oral immunotherapy
Timepoint [3] 307152 0
throughout up-dosing and maintenance phase

Eligibility
Key inclusion criteria
Double blind placebo controlled challenge proven roasted peanut allergy at study commencement
Minimum age
5 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to undertake study requirments

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomisation as per random compuer generation
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
At end of 12 months those control subjects randomized to arm 3 (no intervention) will undertake boiled peanut immunotherapy as per arm one, with same induction, up dosing and maintenance phases and same oral food challenge schedule.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Study is powered to detect a 50 fold change in thershold to roasted peanut at 12 months of immunotherapy compared with control (no intervention). We calculated to have 95% power to detect a 50-fold difference in threshold between the two active arms of the challenge at the 5% significance level we will require 20 peanut peanut allergic children with completed challenges. Allowing for a 30% attrition rate we will recruit 30 peanut allergic children. Primary analysis will be by non parametric t tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2015
Actual
Date of last participant enrolment
Anticipated
1/07/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2175 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 7855 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 288832 0
Hospital
Name [1] 288832 0
Allergy and Immunology department Research Fund, Children's Hospital Westmead
Country [1] 288832 0
Australia
Primary sponsor type
Individual
Name
Professor Dianne E Campbell
Address
Department of Allergy and Immunology
CHW
Westmead
NSW, 2154
Locked Bag 4001
Country
Australia
Secondary sponsor category [1] 287526 0
Hospital
Name [1] 287526 0
Childrens Hospital at Westmead
Address [1] 287526 0
Westmead
NSW 2145
Locked Bag 4001
Country [1] 287526 0
Australia
Other collaborator category [1] 277855 0
Individual
Name [1] 277855 0
Dr Sam Mehr
Address [1] 277855 0
Department of Allergy and Immunology
Childrens Hopsital Westmead
NSW
2145
Locked Bag 4001
Country [1] 277855 0
Australia
Other collaborator category [2] 277856 0
Individual
Name [2] 277856 0
Dr Melanie Wong
Address [2] 277856 0
Department of Allergy and Immunology
CHW
Westmead
NSW, 2145
Locked Bag 4001
Country [2] 277856 0
Australia
Other collaborator category [3] 277863 0
Individual
Name [3] 277863 0
Dr Paul Turner
Address [3] 277863 0
Section of Paediatrics
Imperial College London (St Mary's Campus)
Norfolk Place, London W2 1PG
Country [3] 277863 0
United Kingdom

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290672 0
Sydney Childrens Hopsitals Network HREC
Ethics committee address [1] 290672 0
Ethics committee country [1] 290672 0
Australia
Date submitted for ethics approval [1] 290672 0
01/05/2014
Approval date [1] 290672 0
Ethics approval number [1] 290672 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46718 0
Prof Dianne E Campbell
Address 46718 0
Department of Allergy and Immunology
Childrens Hopsital Westmead
NSW 2145
Locked Bag 4001
Country 46718 0
Australia
Phone 46718 0
+61 2 98453366
Fax 46718 0
+61298453421
Email 46718 0
diannec3@chw.edu.au
Contact person for public queries
Name 46719 0
Dianne E Campbell
Address 46719 0
Department of Allergy and Immunology
Childrens Hopsital Westmead
NSW 2145
Locked Bag 4001
Country 46719 0
Australia
Phone 46719 0
+61 2 98453366
Fax 46719 0
+61298453421
Email 46719 0
diannec3@chw.edu.au
Contact person for scientific queries
Name 46720 0
Dianne E Campbell
Address 46720 0
Department of Allergy and Immunology
Childrens Hopsital Westmead
NSW 2145
Locked Bag 4001
Country 46720 0
Australia
Phone 46720 0
+61 2 98453366
Fax 46720 0
+61298453421
Email 46720 0
diannec3@chw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.