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Completed

NCT Number: NCT02159833

Intranasal Diagnostics in Food Allergy: a Feasibility Study

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.

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Key information

Conditions

Food Allergy Disease Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London / Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal challenge with active substance (food protein)

Other

Intranasal challenge with placebo

Other

Other names: placebo = 0.9% NaCl saline solution

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Acronym: INDY

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jun 10, 2014
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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