Intranasal Diagnostics in Food Allergy: a Feasibility Study

NCT02159833 | Completed

• 1 other identifier: 14SM2069
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

Food allergy; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intranasal threshold to food protein

  20 mins

Study Arms (1)

Intervention

EXPERIMENTAL

Intranasal challenge with food protein or vehicle control

Other: Intranasal challenge with active substance (food protein); Other: Intranasal challenge with placebo

Interventions

Intranasal challenge with active substance (food protein) OTHER

Intervention

Intranasal challenge with placebo OTHER

Also known as: placebo = 0.9% NaCl saline solution

Intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Imperial College London / Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Food Hypersensitivity; Disease

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul J Turner, FRACP PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 10, 2014
• Study Start: October 1, 2014
• Primary Completion: December 21, 2018
• Study Completion: January 4, 2019
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

GB (1)