Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-28 @ 9:30 PM
Study NCT ID:
NCT00348361
Status:
COMPLETED
Last Update Posted:
2008-10-13
First Post:
2006-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], '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': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'lastUpdateSubmitDate': '2008-10-09', 'studyFirstSubmitDate': '2006-06-30', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in expression of key allergy targets in the nose following exposure to allergen. Assessment of protein expression measured by western blotting and immunohistochemistry in nasal biopsy tissue.'}], 'secondaryOutcomes': [{'measure': 'Effect of corticosteroids treatment on the change in target expression following allergen challenge. Nasal lavage fluid and nasal secretions will be measured by ELISA and chemiluminescent assay.'}]}, 'conditionsModule': {'keywords': ['Hay fever', 'biomarkers'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'This study is aimed at validating key therapeutic targets and biomarkers associated with allergic rhinitis. The therapeutic target expression will be investigated after a 7 day course of corticosteroid treatment followed by allergen challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* No signs or symptoms of rhinitis outside of the relevant airborne allergen season.\n\nExclusion criteria:\n\n* History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments.\n* Symptoms of rhinitis at inclusion indicated by total VAS score of \\>40 for the combined symptoms scores for blockage, rhinorrhoea, sneezing, itching) or a single symptom with a VAS score \\>20.\n* Subjects not showing a nasal response to allergen concentration =\\< 10,000 BU/ml.\n* Subjects with positive skin prick test for Dust House Mite.'}, 'identificationModule': {'nctId': 'NCT00348361', 'briefTitle': 'Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Validate Key Therapeutic Targets and Biomarkers During Allergen Exposure in Subjects With Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'ELR100710'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fluticasone Propionate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': 'WC1X 8DA', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MD,MSc, FPPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'GSK'}}}}