Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT00824356
Status:
COMPLETED
Last Update Posted:
2009-06-22
First Post:
2009-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2017-03-03', 'unreleaseDateUnknown': True}, {'resetDate': '2017-04-24', 'releaseDate': '2017-03-14'}, {'resetDate': '2018-02-05', 'releaseDate': '2017-07-11'}, {'releaseDate': '2018-02-15', 'unreleaseDate': '2018-08-15'}], 'estimatedResultsFirstSubmitDate': '2017-03-03'}}, 'conditionBrowseModule': {'meshes': [{'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': 'C558853', 'term': 'GSK 1004723'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-18', 'studyFirstSubmitDate': '2009-01-08', 'studyFirstSubmitQcDate': '2009-01-15', 'lastUpdatePostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in total nasal symptom score 0-4 hours post dose', 'timeFrame': '0-4 hours post dose'}]}, 'conditionsModule': {'keywords': ['Allergic Rhinitis', 'Proof-of-Concept'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.\n* Male\n* Aged 18 - 65\n* Weight 50kg+, BMI 19-32 kg/m2\n* Exhibit response to Challenge Chamber and skin prick test.\n* Non-smoker\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n* No nasal structural abnornmality/polyposis, surgery, infection.\n* any respiratory disease, other than mild asthma or seasonal allergic rhinitis\n* participated in another clinical study within 30 days.\n* Subject has donated a unit of blood within 1 month\n* Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.\n* History of sensitivty to drug\n* History of alcohol/drug abuse within 12 months.\n* Positive Hepatitis B antibody test\n* Positive HIV antibody test\n* Risk of non-compliance with study protocol\n* Perenial allergic rhinitis\n* Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.\n* Past or present disease that may affect outcome, as judge by investigator Specific Immunotherapy within 2 years"}, 'identificationModule': {'nctId': 'NCT00824356', 'briefTitle': 'Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis', 'orgStudyIdInfo': {'id': '110159'}, 'secondaryIdInfos': [{'id': '723 PoC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GSK1004726 (1000mg)', 'description': '1000mg aqueous suspension', 'interventionNames': ['Drug: GSK1004723 (1000mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intranasal spray', 'interventionNames': ['Other: Placebo', 'Drug: GSK1004723 (1000mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GSK1004723 (200mg)', 'description': '200 mg aqueous suspension', 'interventionNames': ['Drug: GSK1004723 (200mg)']}], 'interventions': [{'name': 'GSK1004723 (200mg)', 'type': 'DRUG', 'description': 'Intranasal antihistamine.', 'armGroupLabels': ['GSK1004723 (200mg)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Equivalent to GSK1004723 in presentation etc.', 'armGroupLabels': ['Placebo']}, {'name': 'GSK1004723 (1000mg)', 'type': 'DRUG', 'description': 'Intranasal antihistamine.', 'armGroupLabels': ['GSK1004726 (1000mg)', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'GSK'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-03-03', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2017-03-14', 'type': 'RELEASE'}, {'date': '2017-04-24', 'type': 'RESET'}, {'date': '2017-07-11', 'type': 'RELEASE'}, {'date': '2018-02-05', 'type': 'RESET'}, {'date': '2018-02-15', 'type': 'RELEASE'}, {'date': '2018-08-15', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'GlaxoSmithKline'}}}}