Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-13 @ 3:44 AM
Study NCT ID:
NCT03376295
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2017-11-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness of COPD Treatments
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': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Centre', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The continuous combination treatment duration was short because patients either discontinued one of the components or added another agent.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was not applicable for this study.', 'description': 'This was an observational study and was not designed to assess adverse event; therefore safety reporting was not applicable for this study. Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'LABA-ICS', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LABA-TIO', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1977', 'groupId': 'OG000'}, {'value': '1977', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LABA-ICS', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.'}, {'id': 'OG001', 'title': 'LABA-TIO', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.'}], 'classes': [{'title': 'Moderate/severe exacerbation', 'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}]}, {'title': 'Severe exacerbation', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.20', 'estimateComment': 'The hazard ratio (HR) is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.', 'groupDescription': 'The Cox proportional hazard regression model was used to perform for moderate/severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.36', 'estimateComment': 'HR presented is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.', 'groupDescription': 'The Cox proportional hazard regression model was used to perform for severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Years', 'description': 'The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach.'}, {'type': 'SECONDARY', 'title': 'The Rate of COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1977', 'groupId': 'OG000'}, {'value': '1977', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LABA-ICS', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.'}, {'id': 'OG001', 'title': 'LABA-TIO', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.'}], 'classes': [{'title': 'Moderate/severe exacerbation', 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000'}, {'value': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Severe exacerbation', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000'}, {'value': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.25', 'estimateComment': 'The rate ratio (RR) (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.', 'groupDescription': 'Moderate/severe exacerbation', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.33', 'estimateComment': 'The RR (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.', 'groupDescription': 'Severe exacerbation', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 years', 'description': 'Incidence rates and rate ratios of the moderate or severe exacerbation associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis, estimated.', 'unitOfMeasure': 'Events per participant-year', 'reportingStatus': 'POSTED', 'populationDescription': 'The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach.'}, {'type': 'SECONDARY', 'title': 'The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1977', 'groupId': 'OG000'}, {'value': '1977', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LABA-ICS', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.'}, {'id': 'OG001', 'title': 'LABA-TIO', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.'}], 'classes': [{'title': 'As-treated analysis', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'On-treatment exposure', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.05', 'estimateComment': 'The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score', 'groupDescription': 'The cox proportional hazard regression model was used to perform an as-treated analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.92', 'estimateComment': 'The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score', 'groupDescription': 'The Cox proportional hazard regression model was used to perform an on-treatment analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 years', 'description': 'The number of the first occurences of the hospitalization for community-acquired pneumonia (serious pneumonia)associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis and from the time-dependent on-treatment analysis based on current exposure is presented. On-treatment exposure was based on analysis of current use during the entire 1-year follow-up, allowing patients to switch treatments.', 'unitOfMeasure': 'Hospitalizations', 'reportingStatus': 'POSTED', 'populationDescription': 'The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LABA-ICS', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.'}, {'id': 'FG001', 'title': 'LABA-TIO', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1977'}, {'groupId': 'FG001', 'numSubjects': '1977'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1977'}, {'groupId': 'FG001', 'numSubjects': '1977'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Primary objective was to assess the effectiveness of maintenance treatment of ChronicObstructivePulmonaryDisease (COPD) with combination of Long-acting beta2-agonist(LABA) and the long-acting muscarinic antagonists(LAMA)tiotropium(TIO) compared with the combination of a LABA and an Inhaled corticosteroids(ICS) on the time to COPD exacerbation.', 'preAssignmentDetails': 'Population-based propensity score-matched incident new-user cohort study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1977', 'groupId': 'BG000'}, {'value': '1977', 'groupId': 'BG001'}, {'value': '3954', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LABA-ICS', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.'}, {'id': 'BG001', 'title': 'LABA-TIO', 'description': 'The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1977', 'groupId': 'BG000'}, {'value': '1977', 'groupId': 'BG001'}, {'value': '3954', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.8', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '71.9', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '71.85', 'spread': '8.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1977', 'groupId': 'BG000'}, {'value': '1977', 'groupId': 'BG001'}, {'value': '3954', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '778', 'groupId': 'BG000'}, {'value': '778', 'groupId': 'BG001'}, {'value': '1556', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1199', 'groupId': 'BG000'}, {'value': '1199', 'groupId': 'BG001'}, {'value': '2398', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach. Baseline measures were presented for matched populations.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-19', 'size': 467330, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-18T05:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3954}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-10', 'studyFirstSubmitDate': '2017-11-30', 'resultsFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2017-12-13', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-17', 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry', 'timeFrame': '12 Years', 'description': 'The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.'}], 'secondaryOutcomes': [{'measure': 'The Rate of COPD Exacerbations', 'timeFrame': '12 years', 'description': 'Incidence rates and rate ratios of the moderate or severe exacerbation associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis, estimated.'}, {'measure': 'The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)', 'timeFrame': '12 years', 'description': 'The number of the first occurences of the hospitalization for community-acquired pneumonia (serious pneumonia)associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis and from the time-dependent on-treatment analysis based on current exposure is presented. On-treatment exposure was based on analysis of current use during the entire 1-year follow-up, allowing patients to switch treatments.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the combination of a long-acting bronchodilators (LABA and the long-acting muscarinic antagonists (LAMA) tiotropium (LABA-TIO)) compared with the combination of a LABA and an ICS (LABA-ICS) on the time to COPD exacerbation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The base cohort will consist of all patients with a diagnosis of COPD from 1 January 1995 until 31 December 2015 who subsequently received at least one prescription for a long-acting bronchodilator, either LABA or tiotropium, or for an inhaled corticosteroid, alone or in combination, from 1 January 2002 until 31 December 2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New users of long-acting bronchodilators, LABA and tiotropium on the same date or of LABA and ICS, either as a fixed-dose combination or free combination, on the same date between January 2002 and December 2015\n* Diagnosis of COPD and age ≥ 55 years\n\nExclusion Criteria:\n\n* Less than one year of medical history information prior to the date of combined treatment initiation (cohort entry)\n* Asthma diagnosis'}, 'identificationModule': {'nctId': 'NCT03376295', 'briefTitle': 'Comparative Effectiveness of COPD Treatments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Comparative Effectiveness of Combination Therapies in COPD', 'orgStudyIdInfo': {'id': '0205-0538'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects diagnosed with COPD', 'description': 'Chronic obstructive pulmonary disease', 'interventionNames': ['Drug: LABA and the LAMA tiotropium (LABA-TIO)', 'Drug: LABA and an ICS (LABA-ICS)']}], 'interventions': [{'name': 'LABA and the LAMA tiotropium (LABA-TIO)', 'type': 'DRUG', 'otherNames': ['FORVENT, SPIRIVA, SRIVASSO'], 'description': 'combinational drug', 'armGroupLabels': ['Subjects diagnosed with COPD']}, {'name': 'LABA and an ICS (LABA-ICS)', 'type': 'DRUG', 'description': 'combinational drug', 'armGroupLabels': ['Subjects diagnosed with COPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1E2', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Centre for Clinical Epidemiology, McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}