Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-06 @ 1:28 AM
Study NCT ID:
NCT01331694
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2011-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outcomes and Costs Associated With Initiating Maintenance Treatment With Fluticasone Propionate 250mcg/Salmeterol Xinafoate 50mcg Combination (FSC) Versus Anticholinergics Including Tiotropium (TIO) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'D009241', 'term': 'Ipratropium'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D000068600', 'term': 'Albuterol, Ipratropium Drug Combination'}], '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'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'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': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'This study was a retrospective observational study; thus, no serious adverse events or adverse events were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Risk Population: FSC', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Risk Population: IP', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Risk Population: TIO', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cost Population: FSC', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cost Population: IP', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cost Population: TIO', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Chronic Obstructive Pulmonary Disease (COPD) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16684', 'groupId': 'OG000'}, {'value': '14449', 'groupId': 'OG001'}, {'value': '12659', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Risk Population: FSC', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg'}, {'id': 'OG001', 'title': 'Risk Population: IP', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)'}, {'id': 'OG002', 'title': 'Risk Population TIO', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg'}], 'classes': [{'title': 'Hospitalization or emergency department visit', 'categories': [{'measurements': [{'value': '325.17', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '315.89', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '321.59', 'spread': '0.51', 'groupId': 'OG002'}]}]}, {'title': 'Emergency department visit', 'categories': [{'measurements': [{'value': '330.24', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '324.47', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '328.48', 'spread': '0.37', 'groupId': 'OG002'}]}]}, {'title': 'Outpatient visit with oral steroid fill', 'categories': [{'measurements': [{'value': '332.74', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '328.23', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '331.23', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': 'Outpatient visit with antibiotic fill', 'categories': [{'measurements': [{'value': '329.96', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '326.73', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '326.70', 'spread': '0.39', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '1.50', 'ciUpperLimit': '1.79', 'estimateComment': 'Hazard ratio for hospitalization or emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.41', 'estimateComment': 'Hazard ratio for hospitalization or emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.78', 'ciLowerLimit': '1.59', 'ciUpperLimit': '2.00', 'estimateComment': 'Hazard ratio for emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.51', 'estimateComment': 'Hazard ratio for emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.65', 'ciLowerLimit': '1.41', 'ciUpperLimit': '1.94', 'estimateComment': 'Hazard ratio for outpatient visit with oral steroid fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.76', 'estimateComment': 'Hazard ratio for outpatient visit with oral steroid fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '1.23', 'ciUpperLimit': '1.57', 'estimateComment': 'Hazard ratio for outpatient visit with antibiotic fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.51', 'estimateComment': 'Hazard ratio for outpatient visit with antibiotic fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Anytime from 30 days to 12 months after initial treatment arm prescription', 'description': 'The first COPD event occurring after 30 days from initial treatment arm prescription was measured. Four categories of COPD events were analyzed; either a hospitalization or emergency department visit; an emergency department visit; an outpatient visit followed by an oral corticosteroid prescription claim within 10 days; an outpatient visit followed by an oral antibiotic prescription claim within 10 days.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States.'}, {'type': 'SECONDARY', 'title': 'Average Annual Adjusted Post-Index COPD-Related Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12595', 'groupId': 'OG000'}, {'value': '10617', 'groupId': 'OG001'}, {'value': '9126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cost Population: FSC', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg'}, {'id': 'OG001', 'title': 'Cost Population: IP', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)'}, {'id': 'OG002', 'title': 'Cost Population: TIO', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg'}], 'classes': [{'title': 'Medical', 'categories': [{'measurements': [{'value': '1076', 'spread': '1119', 'groupId': 'OG000'}, {'value': '2481', 'spread': '2770', 'groupId': 'OG001'}, {'value': '1419', 'spread': '1572', 'groupId': 'OG002'}]}]}, {'title': 'Pharmacy', 'categories': [{'measurements': [{'value': '972', 'spread': '175', 'groupId': 'OG000'}, {'value': '614', 'spread': '225', 'groupId': 'OG001'}, {'value': '985', 'spread': '355', 'groupId': 'OG002'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '2068', 'spread': '1190', 'groupId': 'OG000'}, {'value': '2841', 'spread': '1858', 'groupId': 'OG001'}, {'value': '2408', 'spread': '1511', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Incurred over the 12 month period after initial treatment arm prescription', 'description': 'Medical costs are associated with COPD-related medical care (claims submitted with a primary International Classification of Diseases, 9th Revision, Clinical Modification diagnosis of COPD) and pharmaceutical care (treatment arm medications, oral corticosteroids, oral antibiotics, short-acting beta-agonists, long-acting beta-agonists \\[LABA\\], inhaled corticosteroids \\[ICS\\], ICS/LABA combinations, etc.. Means are adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization. Total costs are the sum of medical care and pharmacy costs.', 'unitOfMeasure': 'United States dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Risk Population: FSC', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 micrograms (mcg)/50 mcg'}, {'id': 'FG001', 'title': 'Risk Population: IP', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)'}, {'id': 'FG002', 'title': 'Risk Population: TIO', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg'}, {'id': 'FG003', 'title': 'Cost Population: FSC', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg'}, {'id': 'FG004', 'title': 'Cost Population: IP', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)'}, {'id': 'FG005', 'title': 'Cost Population: TIO', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16684'}, {'groupId': 'FG001', 'numSubjects': '14449'}, {'groupId': 'FG002', 'numSubjects': '12659'}, {'groupId': 'FG003', 'numSubjects': '12595'}, {'groupId': 'FG004', 'numSubjects': '10617'}, {'groupId': 'FG005', 'numSubjects': '9126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16684'}, {'groupId': 'FG001', 'numSubjects': '14449'}, {'groupId': 'FG002', 'numSubjects': '12659'}, {'groupId': 'FG003', 'numSubjects': '12595'}, {'groupId': 'FG004', 'numSubjects': '10617'}, {'groupId': 'FG005', 'numSubjects': '9126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16684', 'groupId': 'BG000'}, {'value': '14449', 'groupId': 'BG001'}, {'value': '12659', 'groupId': 'BG002'}, {'value': '12595', 'groupId': 'BG003'}, {'value': '10617', 'groupId': 'BG004'}, {'value': '9126', 'groupId': 'BG005'}, {'value': '76130', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Risk Population: FSC', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg'}, {'id': 'BG001', 'title': 'Risk Population: IP', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)'}, {'id': 'BG002', 'title': 'Risk Population: TIO', 'description': 'Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg'}, {'id': 'BG003', 'title': 'Cost Population: FSC', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg'}, {'id': 'BG004', 'title': 'Cost Population: IP', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)'}, {'id': 'BG005', 'title': 'Cost Population: TIO', 'description': 'Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '12.00', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '12.59', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '11.33', 'groupId': 'BG002'}, {'value': '62.8', 'spread': '11.92', 'groupId': 'BG003'}, {'value': '65.0', 'spread': '12.42', 'groupId': 'BG004'}, {'value': '64.5', 'spread': '11.34', 'groupId': 'BG005'}, {'value': '64.0', 'spread': '12.06', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Age at initial treatment arm prescription', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9127', 'groupId': 'BG000'}, {'value': '7143', 'groupId': 'BG001'}, {'value': '5862', 'groupId': 'BG002'}, {'value': '6914', 'groupId': 'BG003'}, {'value': '5298', 'groupId': 'BG004'}, {'value': '4256', 'groupId': 'BG005'}, {'value': '38600', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '7557', 'groupId': 'BG000'}, {'value': '7306', 'groupId': 'BG001'}, {'value': '6797', 'groupId': 'BG002'}, {'value': '5681', 'groupId': 'BG003'}, {'value': '5319', 'groupId': 'BG004'}, {'value': '4870', 'groupId': 'BG005'}, {'value': '37530', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender reported in claims records', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-02', 'studyFirstSubmitDate': '2011-03-10', 'resultsFirstSubmitDate': '2011-03-10', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-03-10', 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Chronic Obstructive Pulmonary Disease (COPD) Event', 'timeFrame': 'Anytime from 30 days to 12 months after initial treatment arm prescription', 'description': 'The first COPD event occurring after 30 days from initial treatment arm prescription was measured. Four categories of COPD events were analyzed; either a hospitalization or emergency department visit; an emergency department visit; an outpatient visit followed by an oral corticosteroid prescription claim within 10 days; an outpatient visit followed by an oral antibiotic prescription claim within 10 days.'}], 'secondaryOutcomes': [{'measure': 'Average Annual Adjusted Post-Index COPD-Related Costs', 'timeFrame': 'Incurred over the 12 month period after initial treatment arm prescription', 'description': 'Medical costs are associated with COPD-related medical care (claims submitted with a primary International Classification of Diseases, 9th Revision, Clinical Modification diagnosis of COPD) and pharmaceutical care (treatment arm medications, oral corticosteroids, oral antibiotics, short-acting beta-agonists, long-acting beta-agonists \\[LABA\\], inhaled corticosteroids \\[ICS\\], ICS/LABA combinations, etc.. Means are adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization. Total costs are the sum of medical care and pharmacy costs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '21311689', 'type': 'BACKGROUND', 'citation': 'Dalal AA, Roberts MH, Petersen HV, Blanchette CM, Mapel DW. Comparative cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2010 Dec 31;6:13-22. doi: 10.2147/COPD.S15455.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate COPD-related clinical outcomes and total healthcare utilization in commercially insured (at least 40 years with a subanalysis of those aged 65 years and older) COPD population associated with the use of fluticasone/salmeterol combination (FSC) 250/50mcg compared to other initial maintenance therapies (IMTs), specifically, tiotropium bromide (TIO), and either ipratropium bromide or ipratropium bromide/albuterol (IP).\n\nThis is a hypothesis testing study\n\nHo: There is no difference in time to first COPD-related events between FSC and TIO and FSC and IP Ha: There is a difference in time to first COPD-related events between FSC and TIO and FSC and IP\n\nHypothesis for the key secondary outcome of COPD-related costs that was tested was:\n\nHo: There is no difference in COPD-related costs between FSC and TIO and FSC and IP Ha: There is a difference in COPD-related costs between FSC and TIO and FSC and IP', 'detailedDescription': 'All population i.e. at least 40 years: Each initial maintenance treatment (IMT) cohort (FSC 250/50mcg dose only, IP, and TIO) includes patients aged 40 years and older with at least 9 months of continuous enrollment (6 months pre-index and at least three months post-index) with a primary or secondary diagnosis of COPD \\[International Classification of Disease, 9th revision, Clinical Modification (ICD-9-CM) codes 491.xx, 492.xx or 496.xx\\]. Patients are observed such that everyone provides minimum 6 months of pre index baseline data and minimum 3 months post index (risk analysis) and minimum 12 months post index for cost analysis. Patients must receive either a 30-day supply of FSC or IP or TIO as the initial IMT medication, indicating "intent to treat." Patients may not also have a prescription filled for the other IMT medication within 60 days of the index date, or for the combination therapy budesonide/ formoterol (BFC), an inhaled corticosteroid (ICS) or a long acting beta agonist (LABA). Six months of observation (continuous enrollment) prior to the index date is assessed to confirm that the patient meets the inclusion and exclusion criteria as well as to identify baseline characteristics and covariates. Cost analysis was done using a 12 months fixed follow up period. Outcome measures are assessed during the post-index period\n\nElderly cohort 65+: Identical methods and design were used for subanalyses in patients aged 65 years and over except comparison was FSC vs. TIO only.\n\n75+ cohort: Identical methods and design were used for subanalyses in patients aged 75 years and over except comparison was FSC vs. TIO only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All population i.e. U\\>U40 years: Each initial maintenance treatment (IMT) cohort (FSC 250/50mcg dose only, IP, and TIO) includes patients aged 40 years and older with at least 9 months of continuous enrollment (6 months pre-index and at least three months post-index) with a primary or secondary diagnosis of COPD \\[International Classification of Disease, 9th revision, Clinical Modification (ICD-9-CM) codes 491.xx, 492.xx or 496.xx\\]. Patients are observed such that everyone provides minimum 6 months of pre index baseline data and minimum 3 months post index (risk analysis) and minimum 12 months post index for cost analysis. Patients must receive either a 30-day supply of FSC or IP or TIO as the initial IMT medication, indicating "intent to treat." Patients may not also have a prescription filled for the other IMT medication within 60 days of the index date, or for the combination therapy budesonide/ formoterol (BFC), an inhaled corticosteroid (ICS) or a long acting beta agonist (LABA).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria -\n\nIMT Cohorts (subjects selected by order of criteria)\n\n* claim for one of the study medications and must not receive another study medication within 60 days of the initial maintenance therapy, indicating "intent to treat."\n* at least one COPD-related ED or one COPD-related hospitalization, or two COPD-related outpatient visits (OV) associated with primary or secondary diagnosis for COPD (ICD-9-CM code 491.xx, 492.xx or 496.xx), at any time during the observation period (July 1, 2005 through June 30, 2008) in the database.\n* Aged 65+ years on the index date or aged 40 and over for the sub-analysis.\n* Continuous enrollment in a health plan for at least 6 months prior (pre-index) to initiation of IMT and at least three months after the first initiation of IMT (post-index).\n* at least one prescription claim in the pre-index and each year of the post-index period for which they have follow-up.\n\nExclusion Criteria - All Cohorts\n\n* primary or secondary diagnosis of respiratory tract cancer (larynx, trachea, or pleura). (ICD-9-CM codes 161, 161.X, 162, 163, 163.X, 231, 231.X).\n* In the pre-index period, no claims for any of the cohort IMT medications, nor for any other Advair or budesonide/formoterol fixed dose combination, FSC combination medications, and may only have respiratory medication pharmacy claims for drugs included in the pre-index severity of illness assessment (Methylxanthines, Leukotriene Modifiers/Inhibitors, Omalizumab and Mast Cell Stabilizers).'}, 'identificationModule': {'nctId': 'NCT01331694', 'briefTitle': 'Outcomes and Costs Associated With Initiating Maintenance Treatment With Fluticasone Propionate 250mcg/Salmeterol Xinafoate 50mcg Combination (FSC) Versus Anticholinergics Including Tiotropium (TIO) in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Outcomes and Costs Associated With Initiating Maintenance Treatment With Fluticasone Propionate 250mcg/Salmeterol Xinafoate 50mcg Combination (FSC) Versus Anticholinergics Including Tiotropium (TIO) in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '112646'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD', 'description': 'copd patients 65 years and older', 'interventionNames': ['Drug: fluticasone/salmeterol combination (FSC) 250/50mcg', 'Drug: tiotropium', 'Drug: ipratropium bromide alone or in fixed dose combination with albuterol']}], 'interventions': [{'name': 'fluticasone/salmeterol combination (FSC) 250/50mcg', 'type': 'DRUG', 'otherNames': ['Advair (TM)'], 'description': 'patients initiating treatment with fluticasone/salmeterol combination (FSC) 250/50mcg', 'armGroupLabels': ['COPD']}, {'name': 'tiotropium', 'type': 'DRUG', 'otherNames': ['Spiriva (TM)'], 'description': 'patients initiating treatment with tiotropium', 'armGroupLabels': ['COPD']}, {'name': 'ipratropium bromide alone or in fixed dose combination with albuterol', 'type': 'DRUG', 'otherNames': ['Atrovent (TM)', 'Combivent (TM)'], 'description': 'patients initiating treatment with ipratropium/albuterol', 'armGroupLabels': ['COPD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}