Intranasal Diagnostics in Food Allergy: a Feasibility Study

Not Applicable

Completed

• Conditions: Food Allergy
• Interventions: Other: Intranasal challenge with active substance (food protein); Other: Intranasal challenge with placebo

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Intranasal challenge with placebo	Intranasal challenge with food protein or vehicle control
Intervention	Intranasal challenge with active substance (food protein)	Intranasal challenge with food protein or vehicle control

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