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Trial registered on ANZCTR


Registration number
ACTRN12614000919617
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
27/08/2014
Date last updated
10/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study for a new oral immunotherapy for peanut allergy
Scientific title
A pilot study to test the safety and effectiveness of treatment with boiled peanuts to desensitise children with proven peanut allergy.
Secondary ID [1] 285159 0
Nil
Universal Trial Number (UTN)
Trial acronym
BPPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut allergy 292750 0
Condition category
Condition code
Inflammatory and Immune System 293041 293041 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following confirmation of peanut allergy by a positive open food challenge test, patients aged 6 - 16 will be treated with increasing dosage of boiled peanuts starting with 1/4 of a boiled peanut per day for week 1; 1/4 of a boiled peanut twice a day for week 2 and 1/4 of a boiled peanut 3 times per day for week 3. For subsequent weeks, doses will be increased weekly up to target dose of 10 boiled peanuts in 3 divided doses per day at week 18. This dosage will be maintained for 3.5 months and then patients will return for their first dose of raw peanut, which will be 1/4 of a raw peanut and will be escalated using the same regime as for boiled peanuts until the patients can ingest 10 raw peanuts per day at 18 weeks from the first dose of raw peanut. The dosage will be gradually increased to 10 raw peanuts per day when this dosage will be maintained indefinitely. Treatment compliance and adverse events will be monitored by use of a diary.
Intervention code [1] 290012 0
Treatment: Other
Comparator / control treatment
No control group in this pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292910 0
Proportion of participants that are able to ingest 10 or more raw/roasted peanuts per day on completion of Phase 2 treatment without any ongoing adverse effects. Examples of adverse effects are (in ascending order of severity): skin itchiness, urticaria and angioedema, allergic rhinitis or conjunctivitis, gastrointestinal symptoms such as abdominal pains, vomiting or diarrhoea, respiratory symptoms such as cough, wheeze, or breathing problems, fainting and anaphylaxis, based on clinical history and physical examination.
Timepoint [1] 292910 0
12.5 months
Primary outcome [2] 292911 0
Incidence of adverse events more serious than cutaneous manifestations as a consequence of immunotherapy. Examples of such adverse events are: allergic rhinitis or conjunctivitis, gastrointestinal symptoms such as abdominal pains, vomiting or diarrhoea, respiratory symptoms such as cough, wheeze, or breathing problems, fainting and anaphylaxis, based on clinical history and physical examination
Timepoint [2] 292911 0
12.5 months
Secondary outcome [1] 309914 0
Proportion of participants that are able to ingest 10 or more boiled peanuts per day on completion of Phase 1 treatment without any ongoing adverse effects. Examples of adverse effects are (in ascending order of severity): skin itchiness, urticaria and angioedema, allergic rhinitis or conjunctivitis, gastrointestinal symptoms such as abdominal pains, vomiting or diarrhoea, respiratory symptoms such as cough, wheeze, or breathing problems, fainting and anaphylaxis, based on clinical history and physical examination.
Timepoint [1] 309914 0
8 months

Eligibility
Key inclusion criteria
Patients who are proven to be allergic to peanut by a positive open food challenge test immediately prior to enrolment into the study.
Minimum age
6 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Serious medical co-morbidities.
2. Initial allergic reaction to peanut was life threatening.
3. Parents unable to supervise treatment or unwilling to sign informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with a known history of peanut allergy with positive skin prick test reading >5 mm are invited to participate in the study. No randomisation of treatment will be performed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Patients must be able to ingest 10 boiled peanuts before they are allowed to ingest any amount of raw peanuts.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Patients should be able to tolerate at least 20 times more raw/roasted peanuts than the eliciting dose at open food challenge test. Peanut specific IgE and IgG4 serum levels will be measured before and after treatment. Students t-test will be used for statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2849 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 8537 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 289771 0
Charities/Societies/Foundations
Name [1] 289771 0
Channel 7 Children's Research Foundation
Address [1] 289771 0
PO Box 2438, Regency Park, South Australia 5010
Country [1] 289771 0
Australia
Primary sponsor type
Individual
Name
Dr Billy Tao
Address
Department of Paediatrics
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 288460 0
University
Name [1] 288460 0
Flinders University
Address [1] 288460 0
GPO box 2100
Adelaide
SA 5001
Country [1] 288460 0
Australia
Other collaborator category [1] 278093 0
Individual
Name [1] 278093 0
Dr Tim Chataway
Address [1] 278093 0
Department of Human Physiology
School of Medicine
Flinders University
GPO Box 2100
Adelaide SA 5001
Country [1] 278093 0
Australia
Other collaborator category [2] 278094 0
Individual
Name [2] 278094 0
Dr Kristie Bernardo
Address [2] 278094 0
Department of Human Physiology
School of Medicine
Flinders University
GPO Box 2100
Adelaide SA 5001
Country [2] 278094 0
Australia
Other collaborator category [3] 278095 0
Individual
Name [3] 278095 0
Prof Kevin Forsyth
Address [3] 278095 0
Department of Paediatrics
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country [3] 278095 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291502 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 291502 0
The Flats G5 - Rooms 3 and 4
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 291502 0
Australia
Date submitted for ethics approval [1] 291502 0
24/09/2013
Approval date [1] 291502 0
14/03/2014
Ethics approval number [1] 291502 0
473.13

Summary
Brief summary
Peanut allergy affects more than 1% of the Australian population and the prevalence is increasing. To date, there is no effective treatment. This pilot study will test the safety and effectiveness in peanut allergic children of a biphasic oral immunotherapy using increasing doses of boiled peanuts followed by increasing doses of raw/roasted peanuts. Results from this pilot study will be used to design a large multi-centre randomised controlled trial.
Trial website
Trial related presentations / publications
This study was published in Clinical and Experimental Allergy 2017; 47; 1501-1504.
Public notes

Contacts
Principal investigator
Name 50662 0
Dr Billy Tao
Address 50662 0
Department of Paediatrics
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 50662 0
Australia
Phone 50662 0
+61 8 82044459
Fax 50662 0
+61 8 82043945
Email 50662 0
billy.tao@flinders.edu.au
Contact person for public queries
Name 50663 0
Dr Billy Tao
Address 50663 0
Department of Paediatrics
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 50663 0
Australia
Phone 50663 0
+61 8 82044459
Fax 50663 0
+61 8 82043945
Email 50663 0
billy.tao@flinders.edu.au
Contact person for scientific queries
Name 50664 0
Dr Billy Tao
Address 50664 0
Department of Paediatrics
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 50664 0
Australia
Phone 50664 0
+61 8 82044459
Fax 50664 0
+61 8 82043945
Email 50664 0
billy.tao@flinders.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary