Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/01/2014
Date assigned
16/01/2014
Last edited
29/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
c.buicke@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15942

Study information

Scientific title

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

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes