Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-03 @ 12:39 AM
Study NCT ID:
NCT00662805
Status:
COMPLETED
Last Update Posted:
2014-01-20
First Post:
2008-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, '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': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}], 'ancestors': [{'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'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'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Participants will undergo physical examination and blood pressure measurement. A complete medical history will be taken, as well as blood and urine samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 762}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-16', 'studyFirstSubmitDate': '2008-04-14', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria)', 'timeFrame': '104 weeks', 'description': 'Evaluate adverse events, vital sign reporting, and concomitant medications'}], 'secondaryOutcomes': [{'measure': 'Trough FEV1, FVC and FEV1/ FVC ratio', 'timeFrame': 'every 26 weeks'}, {'measure': "Health status as determined using the St George's Respiratory Questionnaire (SGRQ)", 'timeFrame': 'every 26 weeks'}, {'measure': 'Laboratory assessment including levels of appropriate cardiovascular markers (e.g. CRP, Fibrinogen, PAI-1) and established risk factors, as well as detection of microalbuminuria', 'timeFrame': 'every 26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacovigilance', 'COPD'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5. In the case of AE, there will be another visit (visit 6) as a follow up visit - follow up phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Planned: 1000 / Recruited: 771 / Analyzed: 771 A target enrolment of approximately 1000 subjects is planned, at outpatient sites. Any subject with COPD who has an indication to receive Salmeterol + Fluticasone 50/500mcg twice daily at the discretion of the investigator and has met all the inclusion criteria, may take part in the study.\n\nInclusion criteria\n\n* Outpatient diagnosed with COPD (Criteria of the British Thoracic Society or NHLBI/WHO Global initiative for Chronic Obstructive Lung Disease)\n* FEV1 \\< 50% of the one predicted at treatment start and/or\n* History of repetitive COPD exacerbations and/or\n* Patient remains symptomatic despite regular bronchodilator therapy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.\n\nExclusion Criteria:\n\n* Hypersensitivity to Salmeterol + Fluticasone or any of its excipients\n* Pregnancy, lactation or scheduled pregnancy during the observational period of the study\n* Serious illness/disease, not adequately controlled, or with a potential to interfere with the patients' participation in the present study, according to the investigator/physician's judgment."}, 'identificationModule': {'nctId': 'NCT00662805', 'briefTitle': 'Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A 2-year Observational Study to Evaluate Safety of Seretide 50/500μg Twice Daily Administered by DISKUS, in Patients With COPD', 'orgStudyIdInfo': {'id': '104246'}, 'secondaryIdInfos': [{'id': 'Seretide-pv/GR', 'type': 'OTHER', 'domain': 'GlaxoSmithKline'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Salmeterol/Fluticasone propionate (50/500 μg)', 'description': 'Open label, 6 visits, single arm study', 'interventionNames': ['Drug: Salmeterol/Fluticasone propionate']}], 'interventions': [{'name': 'Salmeterol/Fluticasone propionate', 'type': 'DRUG', 'description': 'Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)', 'armGroupLabels': ['Salmeterol/Fluticasone propionate (50/500 μg)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}