Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-28 @ 5:54 PM
Study NCT ID:
NCT01332461
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2011-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies
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': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'D009241', 'term': 'Ipratropium'}, {'id': 'D000068600', 'term': 'Albuterol, Ipratropium Drug Combination'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'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'}, {'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': 'Fluticasone/Salmeterol Combination (FSC) Cohort', 'description': 'Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Other Maintenance Therapies Cohort', 'description': 'Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '4386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone/Salmeterol Combination (FSC) Cohort', 'description': 'Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day'}, {'id': 'OG001', 'title': 'Other Maintenance Therapies Cohort', 'description': 'Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.649', 'ciLowerLimit': '0.455', 'ciUpperLimit': '0.926', 'estimateComment': 'Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)', 'description': 'The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.', 'unitOfMeasure': 'participants per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge'}, {'type': 'SECONDARY', 'title': 'Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '4386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone/Salmeterol Combination (FSC) Cohort', 'description': 'Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day'}, {'id': 'OG001', 'title': 'Other Maintenance Therapies Cohort', 'description': 'Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.'}], 'classes': [{'title': 'COPD-related hospitalization', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'COPD-related ER visit', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'COPD-related physician + Rx visit', 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000'}, {'value': '37.4', 'groupId': 'OG001'}]}]}, {'title': 'COPD-related hospitalization/ER visit/physician+Rx', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}, {'value': '50.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.601', 'ciLowerLimit': '0.326', 'ciUpperLimit': '1.109', 'pValueComment': 'COPD-related hospitalization', 'estimateComment': 'Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.651', 'ciLowerLimit': '0.434', 'ciUpperLimit': '0.977', 'pValueComment': 'COPD-related ER visit', 'estimateComment': 'Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.815', 'ciLowerLimit': '0.658', 'ciUpperLimit': '1.008', 'pValueComment': 'COPD-related physician + Rx visit', 'estimateComment': 'Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.785', 'ciLowerLimit': '0.649', 'ciUpperLimit': '0.948', 'pValueComment': 'COPD-related hospitalization/ER visit/physician+Rx', 'estimateComment': 'Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)', 'description': 'The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types.', 'unitOfMeasure': 'participants per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge'}, {'type': 'SECONDARY', 'title': 'Mean Monthly COPD-related Costs Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '4386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone/Salmeterol Combination (FSC) Cohort', 'description': 'Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day'}, {'id': 'OG001', 'title': 'Other Maintenance Therapies Cohort', 'description': 'Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.'}], 'classes': [{'title': 'COPD-related total costs', 'categories': [{'measurements': [{'value': '205', 'spread': '459.4', 'groupId': 'OG000'}, {'value': '297', 'spread': '1376.4', 'groupId': 'OG001'}]}]}, {'title': 'COPD-related pharmacy costs', 'categories': [{'measurements': [{'value': '121', 'spread': '121.8', 'groupId': 'OG000'}, {'value': '126', 'spread': '307.7', 'groupId': 'OG001'}]}]}, {'title': 'COPD-related medical costs', 'categories': [{'measurements': [{'value': '84', 'spread': '432.5', 'groupId': 'OG000'}, {'value': '171', 'spread': '1331.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)', 'description': 'Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.', 'unitOfMeasure': 'United States (US) dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluticasone/Salmeterol Combination (FSC) Cohort', 'description': 'Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day'}, {'id': 'FG001', 'title': 'Other Maintenance Therapies Cohort', 'description': 'Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1291'}, {'groupId': 'FG001', 'numSubjects': '4386'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1291'}, {'groupId': 'FG001', 'numSubjects': '4386'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'BG000'}, {'value': '4386', 'groupId': 'BG001'}, {'value': '5677', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluticasone/Salmeterol Combination (FSC) Cohort', 'description': 'Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day'}, {'id': 'BG001', 'title': 'Other Maintenance Therapies Cohort', 'description': 'Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '68.2', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '698', 'groupId': 'BG000'}, {'value': '2183', 'groupId': 'BG001'}, {'value': '2881', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '593', 'groupId': 'BG000'}, {'value': '2203', 'groupId': 'BG001'}, {'value': '2796', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5677}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2011-03-18', 'resultsFirstSubmitDate': '2011-03-18', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-03-18', 'studyFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years', 'timeFrame': 'Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)', 'description': 'The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years', 'timeFrame': 'Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)', 'description': 'The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types.'}, {'measure': 'Mean Monthly COPD-related Costs Per Participant', 'timeFrame': 'Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)', 'description': 'Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '21504260', 'type': 'BACKGROUND', 'citation': "Dalal AA, Shah M, D'Souza AO, Mapel DW. COPD-related healthcare utilization and costs after discharge from a hospitalization or emergency department visit on a regimen of fluticasone propionate-salmeterol combination versus other maintenance therapies. Am J Manag Care. 2011 Mar 1;17(3):e55-65."}]}, 'descriptionModule': {'briefSummary': 'This was a retrospective cross-sectional database study using administrative data (study period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged \\>40 years) having at least one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index event) during the study period was the target population. All subjects were required to have one year of pre-index period baseline data. COPD events of interest were ER, Hospital and physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days. Other censoring events were treatment switch; loss of enrollment; \\>60-day gap between medication fills; or end of study period.\n\nThis study is a non descriptive hypothesis testing study. Key study hypotheses are listed below.\n\nSpecifically the study hypotheses for the primary outcome being tested were:\n\nHo: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha: There is a difference in risk of COPD-related hospitalization between FSC and OMT\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 OMT Ha: There is a difference in COPD-related costs between FSC and OMT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Managed care enrollees (aged \\>40 years) having at least one IP with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one ER visit with primary diagnosis of COPD (index event) during the study period was the target population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one hospitalization with a primary or secondary diagnosis of COPD or at least one ER visit with a primary diagnosis of COPD\n* Initiatiation (prescription) of FSC or non-FSC (i.e. TIO, ICS, LABA, IPR) during peri-index period\n* At least 40 years of age\n* Continuous eligibility in the pre-index, peri-index, and follow-up periods\n\nExclusion Criteria\n\n* Presence of exclusionary comorbid conditions during pre-index, peri-index, and follow-up periods: respiratory cancer, cystic fibrosis, fibrosis due to TB, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis\n* Controller medication use during peri-index period\n* COPD-related hospitalization, ER visit, or physician visit plus OCS/Abx within 3 days of visit during the peri-index period'}, 'identificationModule': {'nctId': 'NCT01332461', 'briefTitle': 'Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies', 'orgStudyIdInfo': {'id': '112609'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD Patients', 'description': 'Patients over the age of 40 with a COPD-related hospital or ER visit', 'interventionNames': ['Drug: fluticasone propionate/salmeterol xinafoate combination', 'Drug: Other maintenance Treatments (OMT)']}], 'interventions': [{'name': 'fluticasone propionate/salmeterol xinafoate combination', 'type': 'DRUG', 'otherNames': ['Advair (TM)'], 'description': 'Patients filling a prescription for fluticasone/salmeterol combination as index drug', 'armGroupLabels': ['COPD Patients']}, {'name': 'Other maintenance Treatments (OMT)', 'type': 'DRUG', 'otherNames': ['Spiriva (TM)', 'Atrovent (TM)', 'Combivent (TM)', 'Serevent (TM)', 'Foradil (TM)'], 'description': 'OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists', 'armGroupLabels': ['COPD Patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}