Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT05402020
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2022-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
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'}, {'id': 'C549647', 'term': 'olodaterol'}], '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 Center', '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': 'Clinically important parameters and reasons for using medications were not available. Anticipated is that a certain level of misclassification of disease conditions occurred. Not accounting for such confounders may have resulted in biased findings. Follow-up was censored resulting in limited follow-up time. This may have compromised statistical power, but was not likely to contribute substantial bias in the comparisons. SEAP template does not contain a document date as per internal SOP.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was not applicable for this study.', 'description': 'This is a non-interventional study using electronic health care records, with data retrieved from Danish National Patient Registry, Danish National Prescription Registry and Danish Register of Causes of Death. No adverse events were collected on an individual case level.', 'eventGroups': [{'id': 'EG000', 'title': 'Tiotropium + Olodaterol Cohort', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3752', 'groupId': 'OG000'}, {'value': '3752', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the ICS + LABA cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'id': 'OG001', 'title': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the Tiotropium + Olodaterol cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '424', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.15', 'estimateComment': 'Ratio calculated as \\[Tio/Olo\\]/\\[ICS/LABA\\]', 'groupDescription': 'Univariate proportional hazards regression was used to compare the time to event (first moderate or severe COPD exacerbations) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Number of subjects with event first moderate or severe COPD exacerbations after index date. The first dispensing of either Tio/Olo or ICS/LABA combined inhaler was defined as the index date.\n\nDefinition of moderate or severe COPD exacerbation:\n\n1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field and a prescription for an oral corticosteroid or an antibiotic for respiratory infections\n2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Event Triple Therapy Escalation After Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3752', 'groupId': 'OG000'}, {'value': '3752', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the ICS + LABA cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'id': 'OG001', 'title': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the Tiotropium + Olodaterol cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.85', 'estimateComment': 'Ratio calculated as \\[Tio/Olo\\]/\\[ICS/LABA\\]', 'groupDescription': 'Univariate proportional hazards regression was used to compare the time to event (triple therapy escalation) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Number of subjects with event triple therapy escalation, defined as any LAMA/ICS/LABA fixed dose combination or any concurrent use for 30 consecutive days of the following:\n\n1. any LAMA/LABA fixed dose combination + any ICS single formulation\n2. any LAMA single formulation + any ICS/LABA fixed dose combination\n3. any LAMA single formulation + any LABA single formulation + any ICS single formulation\n\nThe event date was the 30th day after initiation of triple therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Triple Therapy Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3752', 'groupId': 'OG000'}, {'value': '3752', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the ICS + LABA cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'id': 'OG001', 'title': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the Tiotropium + Olodaterol cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '74.5', 'upperLimit': '77.9'}, {'value': '114.2', 'groupId': 'OG001', 'lowerLimit': '112.1', 'upperLimit': '116.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.9', 'ciLowerLimit': '-60.1', 'ciUpperLimit': '-15.8', 'estimateComment': 'Incidence difference calculated as \\[incidence rate of Tio/Olo\\]-\\[incidence rate of ICS/LABA\\].', 'groupDescription': 'The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.85', 'estimateComment': 'Ratio calculated as \\[incidence rate of Tio/Olo\\]/\\[incidence rate of ICS/LABA\\].', 'groupDescription': 'The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Incidence rate of triple therapy initiation (first event per patient). Triple therapy escalation, defined as any LAMA/ICS/LABA fixed dose combination or any concurrent use for 30 consecutive days of the following:\n\n1. any LAMA/LABA fixed dose combination + any ICS single formulation\n2. any LAMA single formulation + any ICS/LABA fixed dose combination\n3. any LAMA single formulation + any LABA single formulation + any ICS single formulation\n\nIncidence rate calculated as (total number of patients in the cohort experiencing an event of interest for the first time during the given time period) / (total person-time at risk from current use of treatment of cohort during the given period).', 'unitOfMeasure': 'Events(escalations per 1000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3752', 'groupId': 'OG000'}, {'value': '3752', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the ICS + LABA cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'id': 'OG001', 'title': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the Tiotropium + Olodaterol cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.93', 'estimateComment': 'Ratio calculated as \\[Tio/Olo\\]/\\[ICS/LABA\\]', 'groupDescription': 'Univariate proportional hazards regression was used to compare the time to event (first hospitalization for community-acquired pneumonia after initiation of study drug) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Number of subjects with event the first hospitalization for community-acquired pneumonia after initiation of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Prescriptions of Rescue Medications After the Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3752', 'groupId': 'OG000'}, {'value': '3752', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the ICS + LABA cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'id': 'OG001', 'title': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the Tiotropium + Olodaterol cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '5.33'}, {'value': '1.03', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '5.62'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Annualized rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.03', 'estimateComment': 'Annualized rate ratio calculated as \\[annualized rate of Tio/Olo\\]/\\[annualized rate of ICS/LABA\\].', 'groupDescription': 'The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Annualized rate of prescriptions of rescue medications after the index date. Rescue medications were defined as free or combination use of short-acting beta-agonist (SABA) or short-acting muscarinic antagonist (SAMA) or SABA/SAMA.\n\nAnnualized rates were calculated for each cohort as follows: (total number of events in the cohort during the given time period) / (total person-year at risk from current use of treatment of cohort during the given period).', 'unitOfMeasure': 'Events (prescriptions) per Person-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of COPD Exacerbations After Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3752', 'groupId': 'OG000'}, {'value': '3752', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the ICS + LABA cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'id': 'OG001', 'title': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the Tiotropium + Olodaterol cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '4.41'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '4.42'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Annualized rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.18', 'estimateComment': 'Annualized rate ratio calculated as \\[annualized rate of Tio/Olo\\]/\\[annualized rate of ICS/LABA\\].', 'groupDescription': 'The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Annualized rate of moderate or severe COPD exacerbation after the index date. Annualized rate is calculated as follows: number of moderate or severe COPD exacerbations/total patient year at risk=number of exacerbations per patient year.\n\nDefinitions of moderate or severe COPD exacerbation were:\n\n1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections, prescriptions within 30 days of each other were considered as continuation of the initial exacerbation.\n2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD; hospitalizations or emergency room visits within 30 days of each other were considered as continuation of the initial exacerbation.', 'unitOfMeasure': 'Events (exacerbations) per Person-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tiotropium + Olodaterol Cohort', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.'}, {'id': 'FG001', 'title': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3815'}, {'groupId': 'FG001', 'numSubjects': '13203'}]}, {'type': 'Propensity Score-matched Cohorts', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3752'}, {'groupId': 'FG001', 'numSubjects': '3752'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3815'}, {'groupId': 'FG001', 'numSubjects': '13203'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a real-world study to assess effectiveness and safety profiles between tiotropium/olodaterol (Tio/Olo) and Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA). Data sources included Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Only subjects that met all inclusion and none of the exclusion criteria were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3752', 'groupId': 'BG000'}, {'value': '3752', 'groupId': 'BG001'}, {'value': '7504', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tiotropium + Olodaterol Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the ICS + LABA cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'id': 'BG001', 'title': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 Agonists (LABA) Cohort - Propensity Score Matched', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.\n\nSubjects were 1:1 propensity score matched to the Tiotropium + Olodaterol cohort. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for Chronic Obstructive Pulmonary Disease (COPD), use of respiratory drugs of interest, frequency and severity of COPD exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3752', 'groupId': 'BG000'}, {'value': '3752', 'groupId': 'BG001'}, {'value': '7504', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72', 'spread': '12.19', 'groupId': 'BG000'}, {'value': '72', 'spread': '12.76', 'groupId': 'BG001'}, {'value': '72', 'spread': '12.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3752', 'groupId': 'BG000'}, {'value': '3752', 'groupId': 'BG001'}, {'value': '7504', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '451', 'groupId': 'BG000'}, {'value': '458', 'groupId': 'BG001'}, {'value': '909', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3301', 'groupId': 'BG000'}, {'value': '3294', 'groupId': 'BG001'}, {'value': '6595', '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': 'Propensity score matched cohorts: Subjects were 1:1 propensity score matched between cohorts. The two groups were comparable with regards to year of treatment initiation, season of treatment initiation, prior treatment for COPD, use of respiratory drugs of interest, frequency and severity of Chronic Obstructive Pulmonary Disease (COPD) exacerbation, prevalence of major comorbidity, Charlson Comorbidity Index, and concomitant medications.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-23', 'size': 2176092, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-20T06:34', 'hasProtocol': True}, {'date': '2022-12-06', 'size': 5352823, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-20T06:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17018}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2022-05-30', 'resultsFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-08', 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date', 'timeFrame': 'From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Number of subjects with event first moderate or severe COPD exacerbations after index date. The first dispensing of either Tio/Olo or ICS/LABA combined inhaler was defined as the index date.\n\nDefinition of moderate or severe COPD exacerbation:\n\n1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field and a prescription for an oral corticosteroid or an antibiotic for respiratory infections\n2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Event Triple Therapy Escalation After Index Date', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Number of subjects with event triple therapy escalation, defined as any LAMA/ICS/LABA fixed dose combination or any concurrent use for 30 consecutive days of the following:\n\n1. any LAMA/LABA fixed dose combination + any ICS single formulation\n2. any LAMA single formulation + any ICS/LABA fixed dose combination\n3. any LAMA single formulation + any LABA single formulation + any ICS single formulation\n\nThe event date was the 30th day after initiation of triple therapy.'}, {'measure': 'Incidence Rate of Triple Therapy Initiation', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Incidence rate of triple therapy initiation (first event per patient). Triple therapy escalation, defined as any LAMA/ICS/LABA fixed dose combination or any concurrent use for 30 consecutive days of the following:\n\n1. any LAMA/LABA fixed dose combination + any ICS single formulation\n2. any LAMA single formulation + any ICS/LABA fixed dose combination\n3. any LAMA single formulation + any LABA single formulation + any ICS single formulation\n\nIncidence rate calculated as (total number of patients in the cohort experiencing an event of interest for the first time during the given time period) / (total person-time at risk from current use of treatment of cohort during the given period).'}, {'measure': 'Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Number of subjects with event the first hospitalization for community-acquired pneumonia after initiation of study drug.'}, {'measure': 'Annualized Rate of Prescriptions of Rescue Medications After the Index Date', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Annualized rate of prescriptions of rescue medications after the index date. Rescue medications were defined as free or combination use of short-acting beta-agonist (SABA) or short-acting muscarinic antagonist (SAMA) or SABA/SAMA.\n\nAnnualized rates were calculated for each cohort as follows: (total number of events in the cohort during the given time period) / (total person-year at risk from current use of treatment of cohort during the given period).'}, {'measure': 'Annualized Rate of COPD Exacerbations After Index Date', 'timeFrame': 'From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.', 'description': 'Annualized rate of moderate or severe COPD exacerbation after the index date. Annualized rate is calculated as follows: number of moderate or severe COPD exacerbations/total patient year at risk=number of exacerbations per patient year.\n\nDefinitions of moderate or severe COPD exacerbation were:\n\n1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections, prescriptions within 30 days of each other were considered as continuation of the initial exacerbation.\n2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD; hospitalizations or emergency room visits within 30 days of each other were considered as continuation of the initial exacerbation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com/msw/datatransparency', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting β2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. The data used in this study will come from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic obstructive pulmonary disease, included in the NHI database between 2014 and 2019, who received either Tiotropium + Olodaterol or Inhaled Corticosteroids + Long-acting ß2 agonist.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December 2019.\n\n 1. The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date;\n 2. For the main analyses, only fixed dose combination (FDC) inhalers will be included.\n2. Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);\n3. At least one diagnosis of chronic obstructive pulmonary disease (COPD) at any time prior to or on the index date;\n4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs;\n5. At least one record in the health insurance system database\n\nExclusion Criteria:\n\n1. Any use of Tio/Olo, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) in free or fixed form for one year prior to the index date;\n2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date (in a sensitivity analysis we will include patients with asthma);'}, 'identificationModule': {'nctId': 'NCT05402020', 'briefTitle': 'Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Effectiveness of Maintenance Treatment With Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Long-acting β2 Agonists in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data', 'orgStudyIdInfo': {'id': '1237-0110'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tiotropium + Olodaterol cohort', 'description': 'Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.', 'interventionNames': ['Drug: Tiotropium (Tio)', 'Drug: Olodaterol (Olo)']}, {'label': 'Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort', 'description': 'Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.', 'interventionNames': ['Drug: Inhaled corticosteroids (ICS)', 'Drug: Long-acting β2-agonists (LABA)']}], 'interventions': [{'name': 'Tiotropium (Tio)', 'type': 'DRUG', 'description': 'Tiotropium (Tio)', 'armGroupLabels': ['Tiotropium + Olodaterol cohort']}, {'name': 'Inhaled corticosteroids (ICS)', 'type': 'DRUG', 'description': 'Inhaled corticosteroids (ICS)', 'armGroupLabels': ['Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort']}, {'name': 'Olodaterol (Olo)', 'type': 'DRUG', 'description': 'Olodaterol (Olo)', 'armGroupLabels': ['Tiotropium + Olodaterol cohort']}, {'name': 'Long-acting β2-agonists (LABA)', 'type': 'DRUG', 'description': 'Long-acting β2-agonists (LABA)', 'armGroupLabels': ['Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100225', 'city': 'Taipei', 'country': 'China', 'facility': 'National Tawain University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to:\n\nhttps://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}