Contact information
Type
Scientific
Primary contact
Ms Christine Buicke
ORCID ID
Contact details
Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 20 7589 5111
c.buicke@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15942
Study information
Scientific title
Determination of intranasal allergen threshold to egg in children with egg allergy
Acronym
INATE Study
Study hypothesis
Determination of intranasal allergen threshold to egg in children with egg allergy
Ethics approval
14/WM/0016
Study design
Non-randomised; Interventional; Design type: Diagnosis, Not specified, Prevention
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Immediate allergic reaction (<30mins following administration)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
06/01/2014
Overall trial end date
03/10/2014
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 12; UK Sample Size: 12
Participant 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
Recruitment start date
06/01/2014
Recruitment end date
03/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Joint Research Compliance Office
London
W6 8RF
United Kingdom
Funders
Funder type
Government
Funder name
Public Health England (PHE) (UK)
Alternative name(s)
PHE
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary