Clinical Trial: Intranasal Diagnostics in Food Allergy: a Feasibility Study

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:
Sponsor: Imperial College London

Current Primary Outcome: Physiological response to intranasal challenge with a food protein [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: Intranasal threshold to food protein [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Imperial College London

Dates:
Date Received: June 3, 2014
Date Started: October 2014
Date Completion: December 2017
Last Updated: March 8, 2017
Last Verified: March 2017