Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-25 @ 1:00 PM
Study NCT ID:
NCT02159833
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2014-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Diagnostics in Food Allergy: a Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2014-06-03', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiological response to intranasal challenge with a food protein', 'timeFrame': '20mins', '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)."}], 'secondaryOutcomes': [{'measure': 'Intranasal threshold to food protein', 'timeFrame': '20 mins', '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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Food allergy', 'Diagnosis'], 'conditions': ['Food Allergy']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 6 - 17 years old\n* Physician-diagnosis of food allergy on the basis of:\n\n * Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR\n * History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR\n * 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\n* 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.\n\nExclusion Criteria:\n\n* Contraindicated as acutely unwell or current unstable asthma:\n\n * Acute wheeze in last 72 hours requiring treatment\n * Febrile ≥38.0oC in last 72 hours\n * Recent admission to hospital in last 2 weeks for acute asthma\n* Current medication\n\n * Use of asthma reliever medication in last 72 hours\n * Recent administration of a medication containing antihistamine within the last 4 days\n * Current oral steroid for asthma exacerbation or course completed within last 2 weeks'}, 'identificationModule': {'nctId': 'NCT02159833', 'acronym': 'INDY', 'briefTitle': 'Intranasal Diagnostics in Food Allergy: a Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Phase 1/2 Study to Determine the Intranasal Allergen Threshold to Food Proteins in Children With Food Allergy', 'orgStudyIdInfo': {'id': '14SM2069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intranasal challenge with food protein or vehicle control', 'interventionNames': ['Other: Intranasal challenge with active substance (food protein)', 'Other: Intranasal challenge with placebo']}], 'interventions': [{'name': 'Intranasal challenge with active substance (food protein)', 'type': 'OTHER', 'armGroupLabels': ['Intervention']}, {'name': 'Intranasal challenge with placebo', 'type': 'OTHER', 'otherNames': ['placebo = 0.9% NaCl saline solution'], 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College London / Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Paul J Turner, FRACP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}