Determination of intranasal allergen threshold to egg in children with egg allergy

ISRCTN	ISRCTN11376766
DOI	https://doi.org/10.1186/ISRCTN11376766
Secondary identifying numbers	15942

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Ms Christine Buicke
Scientific

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Phone	+44 20 7589 5111
Email	c.buicke@imperial.ac.uk

Study design	Non-randomised; Interventional; Design type: Diagnosis, Not specified, Prevention
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Scientific title	Determination of intranasal allergen threshold to egg in children with egg allergy
Study acronym	INATE Study
Study objectives	Determination of intranasal allergen threshold to egg in children with egg allergy
Ethics approval(s)	14/WM/0016
Health condition(s) or problem(s) studied	Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
Intervention	Primary Intervention, Sequential, incremental doses of aerosolised (food grade) egg white (egg protein) at 0, 0.1, 1, 10 and (where no symptoms are present) 100 µg per nostril (in sterile normal saline), at 30 minute intervals, using a nasal spray.
Intervention type	Other
Primary outcome measure	Immediate allergic reaction (<30mins following administration)
Secondary outcome measures	Not provided at time of registration
Overall study start date	06/01/2014
Completion date	03/10/2014

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	17 Years
Sex	Both
Target number of participants	Planned Sample Size: 12; UK Sample Size: 12
Key inclusion criteria	1. Aged 6 - 17 years old 2. Physiciandiagnosis of egg allergy on the basis of: Positive oral food challenge to egg (conducted under medical supervision) within the last 12 months OR History of convincing clinical reaction to egg within the last 12 months AND positive skin prick test within last 6 months OR Evidence of >95% likelihood of egg allergy (on the basis of serum specific IgE 6.0 IU/mL or above or skin prick test (SPT) 6mm or above to egg white within past 12 months but with no history of oral tolerance to egg 3. Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible.
Key exclusion criteria	1. Contraindicated as acutely unwell or current unstable asthma 1.1. Acute wheeze in last 72 hours requiring treatment 1.2. Febrile =380 deg C in last 72 hours 1.3. Recent admission to hospital in last 2 weeks for acute asthma 2. Current medication 2.1. Use of asthma reliever medication in last 72 hours 2.2. Recent administration of a medication containing antihistamine within the last 4 days 2.3. Current oral steroid for asthma exacerbation or course completed within last 2 weeks
Date of first enrolment	06/01/2014
Date of final enrolment	03/10/2014

Joint Research Compliance Office

London
W6 8RF
United Kingdom

Imperial College London (UK)
University/education

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom

"ROR"	https://ror.org/041kmwe10

Government

Public Health England (PHE) (UK)
Government organisation / National government

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

11/05/2017: No publications found in PubMed, verifying study status with principal investigator