Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-30 @ 3:04 AM
Study NCT ID:
NCT00290368
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2006-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeat Nasal Allergen Challenge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010328', 'term': 'Patch Tests'}, {'id': 'D055556', 'term': 'Nasal Lavage'}], 'ancestors': [{'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D007507', 'term': 'Therapeutic Irrigation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2006-05'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2006-02-10', 'studyFirstSubmitQcDate': '2006-02-10', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Nasal allergen challenge', 'Allergic rhinitis', 'Timothy grass pollen', 'inflammatory mediators'], 'conditions': ['Hayfever']}, 'descriptionModule': {'briefSummary': 'This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.', 'detailedDescription': 'This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years.\n2. Otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies.\n\nExclusion Criteria:\n\n1. Smokers (use of tobacco products in the previous 3 months).\n2. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (FEV1 \\> 80% predicted at screening).'}, 'identificationModule': {'nctId': 'NCT00290368', 'briefTitle': 'Repeat Nasal Allergen Challenge', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Assessment of Inflammatory Mediator and Cellular Changes Following Repeated Nasal Allergen Challenge in Subjects With Allergic Rhinitis Sensitive to Timothy Grass Pollen - a Validation Study', 'orgStudyIdInfo': {'id': 'CPJMR0052104'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Skin Prick Test', 'type': 'PROCEDURE'}, {'name': 'Nasal allergen challenge', 'type': 'PROCEDURE'}, {'name': 'Nasal filter paper placement', 'type': 'PROCEDURE'}, {'name': 'Nasal lavage', 'type': 'PROCEDURE'}, {'name': 'Nasal scrape', 'type': 'PROCEDURE'}, {'name': 'Nasal symptoms score', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6HP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'National Heart & Lung Institute Clinical Studies Unit', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Trevor T Hansel, FRCPath', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}]}}}