Intranasal Diagnostics in Food Allergy: a Feasibility Study (INDY)

Imperial College London

Status

Completed

Conditions

Food Allergy

Treatments

Other: Intranasal challenge with placebo

Other: Intranasal challenge with active substance (food protein)

Study type

Interventional

Funder types

Other

Identifiers

NCT02159833

14SM2069

Details and patient eligibility

About

The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.

Enrollment

31 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 6 - 17 years old
Physician-diagnosis of food allergy on the basis of:
- Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR
- History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR
- Evidence of >95% likelihood of food allergy (on the basis of serum specific IgE or skin prick test (SPT) 8mm or above to the causative food allergen within past 12 months
Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. Participants aged over 16 years will need to provide their owned informed consent.

Exclusion criteria

Contraindicated as acutely unwell or current unstable asthma:
- Acute wheeze in last 72 hours requiring treatment
- Febrile ≥38.0oC in last 72 hours
- Recent admission to hospital in last 2 weeks for acute asthma
Current medication
- Use of asthma reliever medication in last 72 hours
- Recent administration of a medication containing antihistamine within the last 4 days
- Current oral steroid for asthma exacerbation or course completed within last 2 weeks