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Trial record 2 of 340 for:    "Food Allergy"

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

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ClinicalTrials.gov Identifier: NCT02159833
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Food Allergy Other: Intranasal challenge with active substance (food protein) Other: Intranasal challenge with placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 1/2 Study to Determine the Intranasal Allergen Threshold to Food Proteins in Children With Food Allergy
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : January 4, 2019

Resource links provided by the National Library of Medicine


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 Name: placebo = 0.9% NaCl saline solution




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159833


Locations
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United Kingdom
Imperial College London / Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Paul J Turner, FRACP PhD Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02159833     History of Changes
Other Study ID Numbers: 14SM2069
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

Keywords provided by Imperial College London:
Food allergy
Diagnosis

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate