Intranasal Diagnostics in Food Allergy: a Feasibility Study

Not Applicable

Completed

• Conditions: Food Allergy

• Registration Number: NCT02159833
• Lead Sponsor: Imperial College London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Study Start: 2014-10
• Primary Completion: 2018-12-21
• Study Completion: 2019-01-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Physiological response to intranasal challenge with a food protein	20mins	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).

Secondary Outcome Measures

Name	Time	Method
Intranasal threshold to food protein	20 mins	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.

Trial Locations

Locations (1)

Imperial College London / Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom