Intranasal Diagnostics in Food Allergy: a Feasibility Study

Food Allergy Clinical Trial

— INDY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159833
• Other study ID #: 14SM2069
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: January 4, 2019

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 4, 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Intranasal challenge with active substance (food protein)

• Intranasal challenge with placebo

Locations

Country	Name	City	State
United Kingdom	Imperial College London / Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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