Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 9:25 AM
Study NCT ID:
NCT00515268
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2007-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endotoxin Challenge Study For Healthy Men and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549469', 'term': '6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2008-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-04', 'studyFirstSubmitDate': '2007-08-09', 'studyFirstSubmitQcDate': '2007-08-10', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8', 'timeFrame': 'Day 1,Day 7&DAY 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LPS challenge,', 'Healthy volunteers'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/IPC103711?search=study&study_ids=IPC103711#rs', 'label': 'Results for study IPC103711 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females (contraception restrictions),\n* 18-50yrs,\n* BMI 19-31kg/m2,\n* Non-smokers,\n* FEV1 \\>/= 80% predicted\n\nExclusion Criteria:\n\n* Abnormal troponin and/or CK MB,\n* Participated in any GSK study involving the administration of COA for \\>/= 21 days.'}, 'identificationModule': {'nctId': 'NCT00515268', 'briefTitle': 'Endotoxin Challenge Study For Healthy Men and Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Double Blind, Placebo Controlled, Repeat Dose Study to Compare the Effectiveness of Two Doses of GSK256066 With Placebo in Reducing Lung Inflammation Following Segmental LPS Challenge in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'IPC103711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects receiving GSK256066', 'description': 'Eligible subjects will be randomized to receive GSK256066 with inhaled doses of 25 micrograms or 87.5 micrograms once daily for 7 days, administered via an ACCUHALER.', 'interventionNames': ['Drug: GSK256066']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Subjects receiving placebo', 'description': 'Eligible subjects will be randomized to receive placebo for 7 days, administered via an ACCUHALER.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GSK256066', 'type': 'DRUG', 'description': 'GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.', 'armGroupLabels': ['Subjects receiving GSK256066']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will receive placebo inhaler.', 'armGroupLabels': ['Subjects receiving 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': {'type': 'SPONSOR'}}}}