Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 12:31 AM
Study NCT ID:
NCT04926233
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2021-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study
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.\n\nInvestigators 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.\n\nBI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'This study was based on the use of secondary data without access to individual patient data. Adverse events were not collected. Zeros in the numbers of participants at risk and affected in the "All-Cause Mortality", "Serious Adverse Events", and "Other Adverse Events" sections stand for adverse event was not collected and not available for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'US IBM Marketscan - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'UK CPRD GOLD - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021963', 'groupId': 'OG000'}, {'value': '258523', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval', 'description': 'Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).\n\nOnly patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval', 'description': 'Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).\n\nOnly patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '64.4', 'spread': '12.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date of cohort entry (baseline; time of COPD diagnosis).', 'description': 'Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the United States (US) IBM MarketScan was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).'}, {'type': 'PRIMARY', 'title': 'Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79412', 'groupId': 'OG000'}, {'value': '11248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval', 'description': 'Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).\n\nOnly patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.'}, {'id': 'OG001', 'title': 'UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval', 'description': 'Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).\n\nOnly patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.82', 'spread': '13.81', 'groupId': 'OG000'}, {'value': '66.17', 'spread': '11.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date of cohort entry (baseline; time of COPD diagnosis).', 'description': 'Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the the United Kingdom (UK) CPRD GOLD database was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).'}, {'type': 'PRIMARY', 'title': 'Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280486', 'groupId': 'OG000'}, {'value': '1021963', 'groupId': 'OG001'}, {'value': '258523', 'groupId': 'OG002'}, {'value': '90660', 'groupId': 'OG003'}, {'value': '79412', 'groupId': 'OG004'}, {'value': '11248', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).'}, {'id': 'OG001', 'title': 'US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval', 'description': 'Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).\n\nOnly patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval', 'description': 'Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).\n\nOnly patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.'}, {'id': 'OG003', 'title': 'UK CPRD GOLD - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).'}, {'id': 'OG004', 'title': 'UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval', 'description': 'Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).\n\nOnly patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.'}, {'id': 'OG005', 'title': 'UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval', 'description': 'Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).\n\nOnly patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '1.89', 'spread': '1.38', 'groupId': 'OG003'}, {'value': '1.83', 'spread': '1.32', 'groupId': 'OG004'}, {'value': '2.31', 'spread': '1.66', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date of cohort entry (baseline; time of COPD diagnosis).', 'description': 'The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan (contained data collected from January 1, 2008 to March 31, 2018) and the United Kingdom (UK) CPRD GOLD databases (contained data collected from November 21, 1987 to June 30, 2018). Results were reported by overall and by stratified groups according to Tiotropium + Olodaterol approval date for US and UK datasets, respectively.'}, {'type': 'PRIMARY', 'title': 'Age of Patients Receiving First Maintenance Treatment - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53473', 'groupId': 'OG000'}, {'value': '6737', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}, {'value': '26378', 'groupId': 'OG003'}, {'value': '6745', 'groupId': 'OG004'}, {'value': '2237', 'groupId': 'OG005'}, {'value': '10892', 'groupId': 'OG006'}, {'value': '133', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 1MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 1MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 1MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 1MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 1MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 1MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '57.0', 'upperLimit': '73.0'}, {'value': '62.0', 'groupId': 'OG001', 'lowerLimit': '56.0', 'upperLimit': '73.0'}, {'value': '67.0', 'groupId': 'OG002', 'lowerLimit': '59.0', 'upperLimit': '79.0'}, {'value': '62.0', 'groupId': 'OG003', 'lowerLimit': '56.0', 'upperLimit': '72.0'}, {'value': '62.0', 'groupId': 'OG004', 'lowerLimit': '56.0', 'upperLimit': '72.0'}, {'value': '63.0', 'groupId': 'OG005', 'lowerLimit': '58.0', 'upperLimit': '74.0'}, {'value': '64.0', 'groupId': 'OG006', 'lowerLimit': '58.0', 'upperLimit': '75.0'}, {'value': '65.0', 'groupId': 'OG007', 'lowerLimit': '58.0', 'upperLimit': '76.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Age of chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database was reported.', 'unitOfMeasure': 'Years', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'PRIMARY', 'title': 'Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53473', 'groupId': 'OG000'}, {'value': '6737', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}, {'value': '26378', 'groupId': 'OG003'}, {'value': '6745', 'groupId': 'OG004'}, {'value': '2237', 'groupId': 'OG005'}, {'value': '10892', 'groupId': 'OG006'}, {'value': '133', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 1MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 1MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 1MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 1MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 1MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 1MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'PRIMARY', 'title': 'Characteristics of Patients Receiving First Maintenance Treatment - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53473', 'groupId': 'OG000'}, {'value': '6737', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}, {'value': '26378', 'groupId': 'OG003'}, {'value': '6745', 'groupId': 'OG004'}, {'value': '2237', 'groupId': 'OG005'}, {'value': '10892', 'groupId': 'OG006'}, {'value': '133', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 1MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 1MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 1MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 1MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 1MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 1MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'title': 'Upper respiratory tract infection', 'categories': [{'measurements': [{'value': '13803', 'groupId': 'OG000'}, {'value': '2114', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '7151', 'groupId': 'OG003'}, {'value': '1632', 'groupId': 'OG004'}, {'value': '486', 'groupId': 'OG005'}, {'value': '2299', 'groupId': 'OG006'}, {'value': '34', 'groupId': 'OG007'}]}]}, {'title': 'Lower respiratory tract infection', 'categories': [{'measurements': [{'value': '8525', 'groupId': 'OG000'}, {'value': '1160', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '4577', 'groupId': 'OG003'}, {'value': '885', 'groupId': 'OG004'}, {'value': '367', 'groupId': 'OG005'}, {'value': '1474', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '9946', 'groupId': 'OG000'}, {'value': '1253', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '4762', 'groupId': 'OG003'}, {'value': '1014', 'groupId': 'OG004'}, {'value': '651', 'groupId': 'OG005'}, {'value': '2160', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}]}]}, {'title': 'Chronic bronchitis', 'categories': [{'measurements': [{'value': '5161', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '2642', 'groupId': 'OG003'}, {'value': '502', 'groupId': 'OG004'}, {'value': '294', 'groupId': 'OG005'}, {'value': '1066', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}]}, {'title': 'Lung fibrosis', 'categories': [{'measurements': [{'value': '1868', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '882', 'groupId': 'OG003'}, {'value': '207', 'groupId': 'OG004'}, {'value': '108', 'groupId': 'OG005'}, {'value': '405', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Concomitant medications - Oral corticosteroids', 'categories': [{'measurements': [{'value': '23272', 'groupId': 'OG000'}, {'value': '3172', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '12240', 'groupId': 'OG003'}, {'value': '2770', 'groupId': 'OG004'}, {'value': '929', 'groupId': 'OG005'}, {'value': '3959', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}]}, {'title': 'Concomitant medications - Oral antibiotics', 'categories': [{'measurements': [{'value': '37829', 'groupId': 'OG000'}, {'value': '5047', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '19168', 'groupId': 'OG003'}, {'value': '4645', 'groupId': 'OG004'}, {'value': '1508', 'groupId': 'OG005'}, {'value': '7116', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}]}]}, {'title': 'Concomitant medications - Oxygen therapy', 'categories': [{'measurements': [{'value': '4580', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '2094', 'groupId': 'OG003'}, {'value': '625', 'groupId': 'OG004'}, {'value': '305', 'groupId': 'OG005'}, {'value': '1058', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Characteristics of patients receiving first maintenance treatment among chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'PRIMARY', 'title': 'Age of Patients Receiving First Maintenance Treatment - UK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8786', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '1202', 'groupId': 'OG003'}, {'value': '1407', 'groupId': 'OG004'}, {'value': '352', 'groupId': 'OG005'}, {'value': '4675', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'UK CPRD GOLD - 1MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.'}, {'id': 'OG001', 'title': 'UK CPRD GOLD - 1MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'UK CPRD GOLD - 1MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'UK CPRD GOLD - 1MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'UK CPRD GOLD - 1MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'UK CPRD GOLD - 1MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'UK CPRD GOLD - 1MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'UK CPRD GOLD - 1MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '75.0'}, {'value': '67.0', 'groupId': 'OG001', 'lowerLimit': '59.0', 'upperLimit': '75.0'}, {'value': '67.0', 'groupId': 'OG002', 'lowerLimit': '59.0', 'upperLimit': '75.0'}, {'value': '67.0', 'groupId': 'OG003', 'lowerLimit': '59.0', 'upperLimit': '75.0'}, {'value': '68.0', 'groupId': 'OG004', 'lowerLimit': '61.0', 'upperLimit': '75.0'}, {'value': '70.0', 'groupId': 'OG005', 'lowerLimit': '62.0', 'upperLimit': '77.0'}, {'value': '68.0', 'groupId': 'OG006', 'lowerLimit': '60.0', 'upperLimit': '75.0'}, {'value': '69.0', 'groupId': 'OG007', 'lowerLimit': '64.0', 'upperLimit': '73.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Age of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.', 'unitOfMeasure': 'Years', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'PRIMARY', 'title': 'Characteristics of Patients Receiving First Maintenance Treatment - UK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8786', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '1202', 'groupId': 'OG003'}, {'value': '1407', 'groupId': 'OG004'}, {'value': '352', 'groupId': 'OG005'}, {'value': '4675', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'UK CPRD GOLD - 1MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.'}, {'id': 'OG001', 'title': 'UK CPRD GOLD - 1MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'UK CPRD GOLD - 1MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'UK CPRD GOLD - 1MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'UK CPRD GOLD - 1MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'UK CPRD GOLD - 1MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'UK CPRD GOLD - 1MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'UK CPRD GOLD - 1MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'title': 'Upper respiratory tract infection', 'categories': [{'measurements': [{'value': '3802', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '545', 'groupId': 'OG003'}, {'value': '541', 'groupId': 'OG004'}, {'value': '143', 'groupId': 'OG005'}, {'value': '1946', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}]}, {'title': 'Lower respiratory tract infection (not pneumonia)', 'categories': [{'measurements': [{'value': '4835', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}, {'value': '220', 'groupId': 'OG002'}, {'value': '721', 'groupId': 'OG003'}, {'value': '732', 'groupId': 'OG004'}, {'value': '164', 'groupId': 'OG005'}, {'value': '2486', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}]}, {'title': 'Concomitant medications - Oral corticosteroids', 'categories': [{'measurements': [{'value': '2367', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '453', 'groupId': 'OG003'}, {'value': '353', 'groupId': 'OG004'}, {'value': '121', 'groupId': 'OG005'}, {'value': '1140', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Concomitant medications - Oral antibiotics', 'categories': [{'measurements': [{'value': '5133', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '796', 'groupId': 'OG003'}, {'value': '797', 'groupId': 'OG004'}, {'value': '224', 'groupId': 'OG005'}, {'value': '2624', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Characteristics of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'PRIMARY', 'title': 'Age of Patients Receiving Second Maintenance Treatment - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7028', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '1813', 'groupId': 'OG003'}, {'value': '1125', 'groupId': 'OG004'}, {'value': '1834', 'groupId': 'OG005'}, {'value': '1450', 'groupId': 'OG006'}, {'value': '140', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 2MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 2MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 2MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 2MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists(LAMA+LABA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 2MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 2MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '74.0'}, {'value': '63.0', 'groupId': 'OG001', 'lowerLimit': '57.0', 'upperLimit': '74.0'}, {'value': '70.0', 'groupId': 'OG002', 'lowerLimit': '62.0', 'upperLimit': '79.0'}, {'value': '63.0', 'groupId': 'OG003', 'lowerLimit': '58.0', 'upperLimit': '73.0'}, {'value': '63.0', 'groupId': 'OG004', 'lowerLimit': '58.0', 'upperLimit': '73.0'}, {'value': '64.0', 'groupId': 'OG005', 'lowerLimit': '58.0', 'upperLimit': '73.0'}, {'value': '64.0', 'groupId': 'OG006', 'lowerLimit': '59.0', 'upperLimit': '75.0'}, {'value': '65.0', 'groupId': 'OG007', 'lowerLimit': '60.0', 'upperLimit': '78.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Age of patients receiving second maintenance treatment from the United States (US) IBM MarketScan database was reported.', 'unitOfMeasure': 'Years', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'PRIMARY', 'title': 'Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7028', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '1813', 'groupId': 'OG003'}, {'value': '1125', 'groupId': 'OG004'}, {'value': '1834', 'groupId': 'OG005'}, {'value': '1450', 'groupId': 'OG006'}, {'value': '140', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 2MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 2MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 2MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 2MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists(LAMA+LABA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 2MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 2MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'PRIMARY', 'title': 'Characteristics of Patients Receiving Second Maintenance Treatment - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7028', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '1813', 'groupId': 'OG003'}, {'value': '1125', 'groupId': 'OG004'}, {'value': '1834', 'groupId': 'OG005'}, {'value': '1450', 'groupId': 'OG006'}, {'value': '140', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 2MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 2MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 2MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 2MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists(LAMA+LABA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 2MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 2MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '3674', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '920', 'groupId': 'OG003'}, {'value': '628', 'groupId': 'OG004'}, {'value': '998', 'groupId': 'OG005'}, {'value': '749', 'groupId': 'OG006'}, {'value': '73', 'groupId': 'OG007'}]}]}, {'title': 'Upper respiratory tract infection', 'categories': [{'measurements': [{'value': '1842', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '497', 'groupId': 'OG003'}, {'value': '307', 'groupId': 'OG004'}, {'value': '442', 'groupId': 'OG005'}, {'value': '343', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}]}]}, {'title': 'Lower respiratory infections', 'categories': [{'measurements': [{'value': '1385', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '368', 'groupId': 'OG003'}, {'value': '213', 'groupId': 'OG004'}, {'value': '372', 'groupId': 'OG005'}, {'value': '260', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}]}]}, {'title': 'Chronic bronchitis', 'categories': [{'measurements': [{'value': '1095', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '264', 'groupId': 'OG003'}, {'value': '165', 'groupId': 'OG004'}, {'value': '297', 'groupId': 'OG005'}, {'value': '243', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}]}]}, {'title': 'Lung fibrosis', 'categories': [{'measurements': [{'value': '388', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '79', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}]}, {'title': 'Concomitant medications - Oral corticosteroids', 'categories': [{'measurements': [{'value': '4065', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '1019', 'groupId': 'OG003'}, {'value': '595', 'groupId': 'OG004'}, {'value': '1125', 'groupId': 'OG005'}, {'value': '851', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}]}]}, {'title': 'Concomitant medications - Oral antibiotics', 'categories': [{'measurements': [{'value': '5399', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '1399', 'groupId': 'OG003'}, {'value': '833', 'groupId': 'OG004'}, {'value': '1388', 'groupId': 'OG005'}, {'value': '1126', 'groupId': 'OG006'}, {'value': '108', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United States (US) IBM MarketScan database were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'PRIMARY', 'title': 'Age of Patients Receiving Second Maintenance Treatment - UK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2461', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '338', 'groupId': 'OG003'}, {'value': '970', 'groupId': 'OG004'}, {'value': '685', 'groupId': 'OG005'}, {'value': '222', 'groupId': 'OG006'}, {'value': '85', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'UK CPRD GOLD - 2MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy.'}, {'id': 'OG001', 'title': 'UK CPRD GOLD - 2MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'UK CPRD GOLD - 2MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'UK CPRD GOLD - 2MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'UK CPRD GOLD - 2MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'UK CPRD GOLD - 2MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'UK CPRD GOLD - 2MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'UK CPRD GOLD - 2MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000', 'lowerLimit': '61.0', 'upperLimit': '75.0'}, {'value': '68.0', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '74.0'}, {'value': '71.0', 'groupId': 'OG002', 'lowerLimit': '63.0', 'upperLimit': '76.0'}, {'value': '69.0', 'groupId': 'OG003', 'lowerLimit': '61.0', 'upperLimit': '77.0'}, {'value': '68.0', 'groupId': 'OG004', 'lowerLimit': '61.0', 'upperLimit': '74.0'}, {'value': '68.0', 'groupId': 'OG005', 'lowerLimit': '60.0', 'upperLimit': '74.0'}, {'value': '70.0', 'groupId': 'OG006', 'lowerLimit': '62.0', 'upperLimit': '77.0'}, {'value': '68.0', 'groupId': 'OG007', 'lowerLimit': '59.0', 'upperLimit': '73.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Age of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.', 'unitOfMeasure': 'Years', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their second maintenance therapy at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'PRIMARY', 'title': 'Characteristics of Patients Receiving Second Maintenance Treatment - UK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2461', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '338', 'groupId': 'OG003'}, {'value': '970', 'groupId': 'OG004'}, {'value': '685', 'groupId': 'OG005'}, {'value': '222', 'groupId': 'OG006'}, {'value': '85', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'UK CPRD GOLD - 2MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy.'}, {'id': 'OG001', 'title': 'UK CPRD GOLD - 2MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'UK CPRD GOLD - 2MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'UK CPRD GOLD - 2MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'UK CPRD GOLD - 2MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'UK CPRD GOLD - 2MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'UK CPRD GOLD - 2MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'UK CPRD GOLD - 2MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '1375', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}, {'value': '555', 'groupId': 'OG004'}, {'value': '383', 'groupId': 'OG005'}, {'value': '127', 'groupId': 'OG006'}, {'value': '37', 'groupId': 'OG007'}]}]}, {'title': 'Concomitant medications - Oral corticosteroids', 'categories': [{'measurements': [{'value': '1066', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}, {'value': '356', 'groupId': 'OG004'}, {'value': '385', 'groupId': 'OG005'}, {'value': '71', 'groupId': 'OG006'}, {'value': '41', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their second maintenance therapy at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53473', 'groupId': 'OG000'}, {'value': '6737', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}, {'value': '26378', 'groupId': 'OG003'}, {'value': '6745', 'groupId': 'OG004'}, {'value': '2237', 'groupId': 'OG005'}, {'value': '10892', 'groupId': 'OG006'}, {'value': '133', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 1MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 1MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 1MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 1MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 1MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 1MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '26242', 'groupId': 'OG000'}, {'value': '3518', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '12483', 'groupId': 'OG003'}, {'value': '3818', 'groupId': 'OG004'}, {'value': '676', 'groupId': 'OG005'}, {'value': '5515', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - UK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8786', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '1202', 'groupId': 'OG003'}, {'value': '1407', 'groupId': 'OG004'}, {'value': '352', 'groupId': 'OG005'}, {'value': '4675', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'UK CPRD GOLD - 1MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.'}, {'id': 'OG001', 'title': 'UK CPRD GOLD - 1MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'UK CPRD GOLD - 1MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'UK CPRD GOLD - 1MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'UK CPRD GOLD - 1MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'UK CPRD GOLD - 1MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'UK CPRD GOLD - 1MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'UK CPRD GOLD - 1MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '5942', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '712', 'groupId': 'OG003'}, {'value': '960', 'groupId': 'OG004'}, {'value': '207', 'groupId': 'OG005'}, {'value': '3281', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7028', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '1813', 'groupId': 'OG003'}, {'value': '1125', 'groupId': 'OG004'}, {'value': '1834', 'groupId': 'OG005'}, {'value': '1450', 'groupId': 'OG006'}, {'value': '140', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 2MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 2MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 2MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 2MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists(LAMA+LABA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 2MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 2MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '2361', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '684', 'groupId': 'OG003'}, {'value': '426', 'groupId': 'OG004'}, {'value': '505', 'groupId': 'OG005'}, {'value': '451', 'groupId': 'OG006'}, {'value': '40', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - UK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2461', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '338', 'groupId': 'OG003'}, {'value': '970', 'groupId': 'OG004'}, {'value': '685', 'groupId': 'OG005'}, {'value': '222', 'groupId': 'OG006'}, {'value': '85', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'UK CPRD GOLD - 2MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy.'}, {'id': 'OG001', 'title': 'UK CPRD GOLD - 2MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'UK CPRD GOLD - 2MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'UK CPRD GOLD - 2MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'UK CPRD GOLD - 2MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'UK CPRD GOLD - 2MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'UK CPRD GOLD - 2MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'UK CPRD GOLD - 2MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1351', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}, {'value': '590', 'groupId': 'OG004'}, {'value': '299', 'groupId': 'OG005'}, {'value': '144', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their second maintenance therapy at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'SECONDARY', 'title': 'Days Between Index and Initiation of First Maintenance Therapy - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53473', 'groupId': 'OG000'}, {'value': '6737', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}, {'value': '26378', 'groupId': 'OG003'}, {'value': '6745', 'groupId': 'OG004'}, {'value': '2237', 'groupId': 'OG005'}, {'value': '10892', 'groupId': 'OG006'}, {'value': '133', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 1MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 1MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 1MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 1MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 1MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 1MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 1MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '158.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '839.0'}, {'value': '242.0', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '972.0'}, {'value': '233.0', 'groupId': 'OG002', 'lowerLimit': '14.0', 'upperLimit': '902.0'}, {'value': '165.0', 'groupId': 'OG003', 'lowerLimit': '12.0', 'upperLimit': '833.0'}, {'value': '116.0', 'groupId': 'OG004', 'lowerLimit': '15.0', 'upperLimit': '672.0'}, {'value': '78.0', 'groupId': 'OG005', 'lowerLimit': '7.0', 'upperLimit': '770.0'}, {'value': '136.0', 'groupId': 'OG006', 'lowerLimit': '9.0', 'upperLimit': '879.0'}, {'value': '85.0', 'groupId': 'OG007', 'lowerLimit': '6.0', 'upperLimit': '957.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From index date until initiation of first maintenance, up to 3368 days before this study started.', 'description': 'Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'SECONDARY', 'title': 'Days Between Index and Initiation of First Maintenance Therapy - UK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8786', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '1202', 'groupId': 'OG003'}, {'value': '1407', 'groupId': 'OG004'}, {'value': '352', 'groupId': 'OG005'}, {'value': '4675', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'UK CPRD GOLD - 1MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.'}, {'id': 'OG001', 'title': 'UK CPRD GOLD - 1MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'UK CPRD GOLD - 1MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'UK CPRD GOLD - 1MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'UK CPRD GOLD - 1MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'UK CPRD GOLD - 1MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'UK CPRD GOLD - 1MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'UK CPRD GOLD - 1MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '521.0'}, {'value': '708.0', 'groupId': 'OG001', 'lowerLimit': '43.0', 'upperLimit': '3145.0'}, {'value': '43.5', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '555.0'}, {'value': '32.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '566.0'}, {'value': '19.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '368.0'}, {'value': '19.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '141.5'}, {'value': '22.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '376.0'}, {'value': '19.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '123.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From index date until initiation of first maintenance therapy, up to 9795 days before this study started.', 'description': 'Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'SECONDARY', 'title': 'Days Between First and Second Maintenance Therapy - US', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7028', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '1813', 'groupId': 'OG003'}, {'value': '1125', 'groupId': 'OG004'}, {'value': '1834', 'groupId': 'OG005'}, {'value': '1450', 'groupId': 'OG006'}, {'value': '140', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'US IBM Marketscan - 2MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.'}, {'id': 'OG001', 'title': 'US IBM Marketscan - 2MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'US IBM Marketscan - 2MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'US IBM Marketscan - 2MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists(LAMA+LABA) were included in this group.'}, {'id': 'OG005', 'title': 'US IBM Marketscan - 2MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'US IBM Marketscan - 2MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'US IBM Marketscan - 2MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their second maintenance therapy (2MT) and were free from asthma prior to initiation of first maintenance therapy.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '160.0', 'groupId': 'OG000', 'lowerLimit': '76.0', 'upperLimit': '335.0'}, {'value': '181.5', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '339.5'}, {'value': '176.0', 'groupId': 'OG002', 'lowerLimit': '86.0', 'upperLimit': '282.0'}, {'value': '158.0', 'groupId': 'OG003', 'lowerLimit': '74.0', 'upperLimit': '321.0'}, {'value': '223.0', 'groupId': 'OG004', 'lowerLimit': '100.0', 'upperLimit': '415.0'}, {'value': '143.5', 'groupId': 'OG005', 'lowerLimit': '70.0', 'upperLimit': '314.0'}, {'value': '137.0', 'groupId': 'OG006', 'lowerLimit': '66.0', 'upperLimit': '301.0'}, {'value': '125.0', 'groupId': 'OG007', 'lowerLimit': '67.0', 'upperLimit': '266.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 1020 days before this study started.', 'description': 'Days between first and second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database were reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.'}, {'type': 'SECONDARY', 'title': 'Days Between First and Second Maintenance Therapy - UK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2461', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '338', 'groupId': 'OG003'}, {'value': '970', 'groupId': 'OG004'}, {'value': '685', 'groupId': 'OG005'}, {'value': '222', 'groupId': 'OG006'}, {'value': '85', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'UK CPRD GOLD - 2MT - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy.'}, {'id': 'OG001', 'title': 'UK CPRD GOLD - 2MT - ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Inhaled Corticosteroid (ICS) were included in this group.'}, {'id': 'OG002', 'title': 'UK CPRD GOLD - 2MT - LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists (LABA) were included in this group.'}, {'id': 'OG003', 'title': 'UK CPRD GOLD - 2MT - LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Inhaled Corticosteroid (LABA+ICS) were included in this group.'}, {'id': 'OG004', 'title': 'UK CPRD GOLD - 2MT - LAMA+LABA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Beta-Agonists + Long-Acting Muscarinic Antagonists (LABA+LAMA) were included in this group.'}, {'id': 'OG005', 'title': 'UK CPRD GOLD - 2MT - LAMA+LABA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Long-Acting Beta-Agonists + Inhaled Corticosteroid (LAMA+LABA+ICS) were included in this group.'}, {'id': 'OG006', 'title': 'UK CPRD GOLD - 2MT - LAMA', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their second maintenance therapy (2MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.'}, {'id': 'OG007', 'title': 'UK CPRD GOLD - 2MT - LAMA+ICS', 'description': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma.\n\nOnly patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '218.0', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '428.0'}, {'value': '239.5', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '528.0'}, {'value': '141.0', 'groupId': 'OG002', 'lowerLimit': '74.0', 'upperLimit': '412.0'}, {'value': '155.5', 'groupId': 'OG003', 'lowerLimit': '67.0', 'upperLimit': '335.0'}, {'value': '284.0', 'groupId': 'OG004', 'lowerLimit': '113.0', 'upperLimit': '483.0'}, {'value': '197.0', 'groupId': 'OG005', 'lowerLimit': '82.0', 'upperLimit': '397.0'}, {'value': '225.5', 'groupId': 'OG006', 'lowerLimit': '96.0', 'upperLimit': '415.0'}, {'value': '158.0', 'groupId': 'OG007', 'lowerLimit': '71.0', 'upperLimit': '281.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 10133 days before this study started.', 'description': 'Days between first and second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their second maintenance therapy at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'US IBM Marketscan - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).'}, {'id': 'FG001', 'title': 'UK CPRD GOLD - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1280486'}, {'groupId': 'FG001', 'numSubjects': '90660'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1280486'}, {'groupId': 'FG001', 'numSubjects': '90660'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This retrospective cohort study used previously collected administrative healthcare data (United States data from IBM MarketScan and United Kingdom data from CPRD GOLD, a primary care database) to describe the patients characteristics and treatment patterns in patients with chronic obstructive pulmonary disease (COPD), initiating tiotropium + olodaterol or other maintenance therapies.', 'preAssignmentDetails': 'Patients with chronic obstructive pulmonary disease (COPD) who met all inclusion criteria and none of the exclusion criteria initiating tiotropium + olodaterol or other maintenance therapies from either IBM MarketScan (United States) or CPRD GOLD (United Kingdom) databases were included.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1280486', 'groupId': 'BG000'}, {'value': '90660', 'groupId': 'BG001'}, {'value': '1371146', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'US IBM Marketscan - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).'}, {'id': 'BG001', 'title': 'UK CPRD GOLD - Overall', 'description': 'All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1280486', 'groupId': 'BG000'}, {'value': '90660', 'groupId': 'BG001'}, {'value': '1371146', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.3', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '65.9', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '65.3', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1280486', 'groupId': 'BG000'}, {'value': '90660', 'groupId': 'BG001'}, {'value': '1371146', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '649296', 'groupId': 'BG000'}, {'value': '46923', 'groupId': 'BG001'}, {'value': '696219', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '631190', 'groupId': 'BG000'}, {'value': '43737', 'groupId': 'BG001'}, {'value': '674927', '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': 'All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan (contained data collected from January 1, 2008 to March 31, 2018) and the United Kingdom (UK) CPRD GOLD databases (contained data collected from November 21, 1987 to June 30, 2018).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-22', 'size': 1694623, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-21T10:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1371146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2021-06-13', 'resultsFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-06-13', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-29', 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US', 'timeFrame': 'At index date of cohort entry (baseline; time of COPD diagnosis).', 'description': 'Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the United States (US) IBM MarketScan was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).'}, {'measure': 'Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK', 'timeFrame': 'At index date of cohort entry (baseline; time of COPD diagnosis).', 'description': 'Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the the United Kingdom (UK) CPRD GOLD database was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).'}, {'measure': 'Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis', 'timeFrame': 'At index date of cohort entry (baseline; time of COPD diagnosis).', 'description': 'The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.'}, {'measure': 'Age of Patients Receiving First Maintenance Treatment - US', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Age of chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database was reported.'}, {'measure': 'Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.'}, {'measure': 'Characteristics of Patients Receiving First Maintenance Treatment - US', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Characteristics of patients receiving first maintenance treatment among chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database were reported.'}, {'measure': 'Age of Patients Receiving First Maintenance Treatment - UK', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Age of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.'}, {'measure': 'Characteristics of Patients Receiving First Maintenance Treatment - UK', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Characteristics of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.'}, {'measure': 'Age of Patients Receiving Second Maintenance Treatment - US', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Age of patients receiving second maintenance treatment from the United States (US) IBM MarketScan database was reported.'}, {'measure': 'Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.'}, {'measure': 'Characteristics of Patients Receiving Second Maintenance Treatment - US', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United States (US) IBM MarketScan database were reported.'}, {'measure': 'Age of Patients Receiving Second Maintenance Treatment - UK', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Age of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.'}, {'measure': 'Characteristics of Patients Receiving Second Maintenance Treatment - UK', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - US', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported.'}, {'measure': 'Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - UK', 'timeFrame': 'At index date of the first maintenance treatment', 'description': 'Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.'}, {'measure': 'Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - US', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database was reported.'}, {'measure': 'Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - UK', 'timeFrame': 'At index date of the second maintenance treatment', 'description': 'Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.'}, {'measure': 'Days Between Index and Initiation of First Maintenance Therapy - US', 'timeFrame': 'From index date until initiation of first maintenance, up to 3368 days before this study started.', 'description': 'Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported.'}, {'measure': 'Days Between Index and Initiation of First Maintenance Therapy - UK', 'timeFrame': 'From index date until initiation of first maintenance therapy, up to 9795 days before this study started.', 'description': 'Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.'}, {'measure': 'Days Between First and Second Maintenance Therapy - US', 'timeFrame': 'From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 1020 days before this study started.', 'description': 'Days between first and second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database were reported.'}, {'measure': 'Days Between First and Second Maintenance Therapy - UK', 'timeFrame': 'From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 10133 days before this study started.', 'description': 'Days between first and second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of the study are to use US and UK data to describe the characteristics of Chronic Obstructive Pulmonary Disease (COPD) patients according to various demographic, lifestyle, clinical, and medication use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population for the analysis will consist of all patients with at least one medical claim with a diagnosis code of COPD identified.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* parent cohort\n\n \\-- COPD diagnosis\n* child cohort\n\n \\-- any initiation of first maintenance therapy after July 1, 2015\n* grandchild cohort -- any initiation of second maintenance therapy after August 2, 2015\n\nExclusion criteria:\n\n\\- parent cohort\n\n* age \\<40 on index date\n* any COPD diagnosis in baseline\n* any use of long-acting muscarinic antagonists (LAMA), long-acting beta-agonists (LABA), or inhaled corticosteroid (ICS) in baseline\n* \\<365 days of continuous medical and pharmacy coverage'}, 'identificationModule': {'nctId': 'NCT04926233', 'briefTitle': 'Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study', 'orgStudyIdInfo': {'id': '1237-0091'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD patients from US IBM Marketscan database', 'interventionNames': ['Drug: Tiotropium bromide + Olodaterol', 'Device: Sp(t)iolto® Respimat®']}, {'label': 'COPD patients from UK CPRD GOLD database', 'interventionNames': ['Drug: Tiotropium bromide + Olodaterol', 'Device: Sp(t)iolto® Respimat®']}], 'interventions': [{'name': 'Tiotropium bromide + Olodaterol', 'type': 'DRUG', 'otherNames': ['Sp(t)iolto® Respimat®'], 'description': 'Tiotropium bromide + Olodaterol', 'armGroupLabels': ['COPD patients from UK CPRD GOLD database', 'COPD patients from US IBM Marketscan database']}, {'name': 'Sp(t)iolto® Respimat®', 'type': 'DEVICE', 'description': 'Sp(t)iolto® Respimat®', 'armGroupLabels': ['COPD patients from UK CPRD GOLD database', 'COPD patients from US IBM Marketscan database']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10018', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'AETION inc', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, '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, except for the following exclusions:\n\n1. studies in products where Boehringer Ingelheim is not the license holder;\n2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;\n3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datasharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}