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

Primary Purpose

Food Allergy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intranasal challenge with active substance (food protein)
Intranasal challenge with placebo
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Food Allergy focused on measuring Food allergy, Diagnosis

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imperial College London / Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Intranasal challenge with food protein or vehicle control

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
June 3, 2014
Last Updated
February 15, 2019
Sponsor
Imperial College London
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02159833
Brief Title
Intranasal Diagnostics in Food Allergy: a Feasibility Study
Acronym
INDY
Official Title
Phase 1/2 Study to Determine the Intranasal Allergen Threshold to Food Proteins in Children With Food Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
January 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
Food allergy, Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intranasal challenge with food protein or vehicle control
Intervention Type
Other
Intervention Name(s)
Intranasal challenge with active substance (food protein)
Intervention Type
Other
Intervention Name(s)
Intranasal challenge with placebo
Other Intervention Name(s)
placebo = 0.9% NaCl saline solution
Primary Outcome Measure Information:
Title
Physiological response to intranasal challenge with a food protein
Description
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).
Time Frame
20mins
Secondary Outcome Measure Information:
Title
Intranasal threshold to food protein
Description
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.
Time Frame
20 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Turner, FRACP PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London / Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

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Intranasal Diagnostics in Food Allergy: a Feasibility Study

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