Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-04-01 @ 2:51 AM
Study NCT ID:
NCT00144859
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2005-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland']}, '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': 'C574213', 'term': 'dilmapimod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics'}]}, 'conditionsModule': {'keywords': ['P38 map kinase', 'CRP', 'COPD', 'safety'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'This is a 28-day, placebo controlled clinical study assessing the safety, tolerability anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic Obstructive Pulmonary Disease).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Non-childbearing potential.\n* Clinical diagnosis of COPD.\n* Cigarette smoking history of greater than or equal to 10 pack years.\n* Post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) \\< 0.7\n* Post-bronchodilator FEV1 50% - 80% of predicted normal.\n* Receiving inhaled corticosteroids for a minimum of 6 weeks prior to Screening.\n* Serum CRP concentration greater than 3mg/L.\n\nExclusion criteria:\n\n* Current diagnosis of asthma.\n* Active tuberculosis, sarcoidosis or bronchiectasis.\n* History of any type of malignancy, rheumatoid arthritis or other conditions associated with chronic inflammation.\n* Clinically significant renal or hepatic disease.\n* History of increased liver function tests, or patients receiving hormone replacement therapy, statins or systemic or topical corticosteroids.'}, 'identificationModule': {'nctId': 'NCT00144859', 'briefTitle': 'Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A 28-day, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 7.5 mg Per Day in Patients With Chronic Obstructive Pulmonary Disease.', 'orgStudyIdInfo': {'id': 'MKC101614'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SB681323', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-9100', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2400', 'city': 'København NV', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.71258, 'lon': 12.52343}}, {'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '82131', 'city': 'Gauting', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': '20535', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '22927', 'city': 'Großhansdorf', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'zip': '3317 NM', 'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '3000 DR', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'LE3 9QP', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'Northumberland', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'BT9 6AB', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'HU16 5JQ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'E2 9JX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}