Topic: Medicines for Children Research Network
Conditions
Interventions
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 salin
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate allergic reaction (<30mins following administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed