Intranasal Diagnostics in Food Allergy: a Feasibility Study (INDY)

March 27, 2024 updated by: Imperial College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1NY
        • Imperial College London / Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intranasal challenge with food protein or vehicle control
Other: Intranasal challenge with active substance (food protein)
Other: Intranasal challenge with placebo
Other Names:
  • placebo = 0.9% NaCl saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
20mins

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Paul J Turner, FRACP PhD, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

December 21, 2018

Study Completion (Actual)

January 4, 2019

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimated)

June 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14SM2069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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