Intranasal Diagnostics in Food Allergy: a Feasibility Study

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1/2 Study to Determine the Intranasal Allergen Threshold to Food Proteins in Children With Food Allergy

Conditions
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Food Allergy

Intervention / Treatment
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* Other: Intranasal challenge with active substance (food protein)
* Other: Intranasal challenge with placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intranasal challenge with food protein or vehicle control | Other: Intranasal challenge with active substance (food protein)<br> <br> Other: Intranasal challenge with placebo<br> <br> * Other names: placebo = 0.9% NaCl saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological response to intranasal challenge with a food protein | The physiological response to food (egg/cow's milk/soya/wheat/peanut) protein when administered into the human nasal airway in food-allergic children with the corresponding food allergy. This will be assessed objectively (using acoustic rhinometry and peak nasal inspiratory flow) as well as subjectively (using a validated Symptom Scoring questionnaire). | 20mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intranasal threshold to food protein | The intranasal threshold to food (egg/cow's milk/soya/wheat/peanut) protein to elicit a local physiological response in food-allergic children (with the corresponding food allergy), as defined by objective assessment described above. | 20 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food allergy, Diagnosis