Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-04 @ 1:48 PM
Study NCT ID:
NCT03663569
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler
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'}]}}, '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': {'timeFrame': 'From start of treatment until end of observation or discontinuation of treatment, whichever occurred first, up to 29 weeks.', 'description': 'Treated set (TS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), and at least one documented administration of Spiolto® Respimat®.', 'eventGroups': [{'id': 'EG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.', 'otherNumAtRisk': 4819, 'deathsNumAtRisk': 4819, 'otherNumAffected': 0, 'seriousNumAtRisk': 4819, 'deathsNumAffected': 7, 'seriousNumAffected': 8}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4819, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4819, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4819, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4819, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4819, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4819, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4700', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.38', 'groupId': 'OG000', 'lowerLimit': '80.24', 'upperLimit': '82.49'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Visit 2 (6 weeks after baseline visit 1)', 'description': 'Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.'}, {'type': 'SECONDARY', 'title': 'Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4700', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'classes': [{'title': 'Symptom', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.97', 'groupId': 'OG000'}]}]}, {'title': 'Functional state', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Mental state', 'categories': [{'measurements': [{'value': '1.04', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Total CCQ score', 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline visit 1 and 6 weeks thereafter at visit 2', 'description': 'The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. Symptom domain covered 4 questions (number 1, 2, 5, 6), Functional state domain covered 4 questions (number 7, 8, 9, 10), and Mental state domain covered 2 questions (number 3, 4). Scores for the questions in each domain were summed up and divided by the number of questions in each domain giving the resulting score for respective domain. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.'}, {'type': 'SECONDARY', 'title': "Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '4700', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'classes': [{'categories': [{'title': 'PGE score = 1', 'measurements': [{'value': '44', 'groupId': 'OG000'}]}, {'title': 'PGE score = 2', 'measurements': [{'value': '471', 'groupId': 'OG000'}]}, {'title': 'PGE score = 3', 'measurements': [{'value': '1176', 'groupId': 'OG000'}]}, {'title': 'PGE score = 4', 'measurements': [{'value': '1428', 'groupId': 'OG000'}]}, {'title': 'PGE score = 5', 'measurements': [{'value': '888', 'groupId': 'OG000'}]}, {'title': 'PGE score = 6', 'measurements': [{'value': '539', 'groupId': 'OG000'}]}, {'title': 'PGE score = 7', 'measurements': [{'value': '140', 'groupId': 'OG000'}]}, {'title': 'PGE score = 8', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At visit 1', 'description': 'PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.'}, {'type': 'SECONDARY', 'title': "Physician's Global Evaluation (PGE) Score at Visit 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '4700', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'classes': [{'categories': [{'title': 'PGE score = 1', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'PGE score = 2', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'PGE score = 3', 'measurements': [{'value': '212', 'groupId': 'OG000'}]}, {'title': 'PGE score = 4', 'measurements': [{'value': '661', 'groupId': 'OG000'}]}, {'title': 'PGE score = 5', 'measurements': [{'value': '1227', 'groupId': 'OG000'}]}, {'title': 'PGE score = 6', 'measurements': [{'value': '1468', 'groupId': 'OG000'}]}, {'title': 'PGE score = 7', 'measurements': [{'value': '891', 'groupId': 'OG000'}]}, {'title': 'PGE score = 8', 'measurements': [{'value': '192', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.'}, {'type': 'SECONDARY', 'title': 'Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4700', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '1474', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '2055', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '803', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Not answered', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4700', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '1579', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '2119', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '694', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Not answered', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4700', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '1554', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '2083', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '711', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Not answered', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4700', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '4539', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4819'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4756'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Discontinuation of study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Never taken Spiolto® Respimat®', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Deceased patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': "Patient's request", 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Not come to second visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Not meet inclusion / exclusion criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This open-label self-controlled observational study over an observational period of 6 weeks (2 visits) was to investigate the potential changes in clinical control of Chronic Obstructive Pulmonary Disease (COPD) patients measured by the Clinical COPD Questionnaire (CCQ) during treatment with Spiolto® Respimat® in routine practice.', 'preAssignmentDetails': 'All patients were screened for eligibility prior to participation in the trial. Patients attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4819', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4819', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65.38', 'spread': '9.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4819', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1459', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3360', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Treated set (TS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), and at least one documented administration of Spiolto® Respimat®.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-26', 'size': 558082, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-09T04:26', 'hasProtocol': True}, {'date': '2019-07-19', 'size': 254896, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-28T08:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4819}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2018-07-26', 'resultsFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-29', 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2', 'timeFrame': 'At Visit 2 (6 weeks after baseline visit 1)', 'description': 'Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.'}], 'secondaryOutcomes': [{'measure': 'Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2', 'timeFrame': 'At baseline visit 1 and 6 weeks thereafter at visit 2', 'description': 'The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. Symptom domain covered 4 questions (number 1, 2, 5, 6), Functional state domain covered 4 questions (number 7, 8, 9, 10), and Mental state domain covered 2 questions (number 3, 4). Scores for the questions in each domain were summed up and divided by the number of questions in each domain giving the resulting score for respective domain. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1.'}, {'measure': "Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)", 'timeFrame': 'At visit 1', 'description': 'PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).'}, {'measure': "Physician's Global Evaluation (PGE) Score at Visit 2", 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).'}, {'measure': 'Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2', 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.'}, {'measure': 'Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2', 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported'}, {'measure': 'Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2', 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.'}, {'measure': 'Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2', 'timeFrame': 'At visit 2 (6 weeks after baseline visit 1)', 'description': 'Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Around 4500 COPD patients from approximately 11 countries will be collected, with a signed informed consent will be maintained in the ISF at the investigational site irrespective of whether they have been treated or not.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent prior to participation\n* Female and male patients ≥40 years of age\n* Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines\n\nExclusion Criteria:\n\n* Patients with contraindications according to Spiolto® Respimat® SmPC\n* Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry\n* Patients continuing LABA/ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists\n* Pregnancy and lactation\n* Current participation in any clinical trial or any other non-interventional study of a drug or device."}, 'identificationModule': {'nctId': 'NCT03663569', 'briefTitle': 'A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Changes in Clinical Control of COPD Patients Measured by the Clinical COPD Questionnaire During Therapy With Spiolto®Respimat® in Routine Clinical Practice', 'orgStudyIdInfo': {'id': '1237-0072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'subjects with COPD', 'interventionNames': ['Drug: Spiolto® Respimat®']}], 'interventions': [{'name': 'Spiolto® Respimat®', 'type': 'DRUG', 'description': 'Drug', 'armGroupLabels': ['subjects with COPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Dupnitsa', 'country': 'Bulgaria', 'facility': 'MBAL Sveti Ivan Rilski-2003', 'geoPoint': {'lat': 42.26478, 'lon': 23.11723}}, {'zip': '5300', 'city': 'Gabrovo', 'country': 'Bulgaria', 'facility': 'SBALBB "Pencho Semov" - Gabrovo EOOD', 'geoPoint': {'lat': 42.87419, 'lon': 25.31823}}, {'zip': '6300', 'city': 'Haskovo', 'country': 'Bulgaria', 'facility': 'SBALPFZ Haskovo EOOD', 'geoPoint': {'lat': 41.93415, 'lon': 25.55557}}, {'zip': '4300', 'city': 'Karlovo', 'country': 'Bulgaria', 'facility': 'MBAL Kiro Popov EOOD', 'geoPoint': {'lat': 42.63333, 'lon': 24.8}}, {'zip': '3320', 'city': 'Kozloduy', 'country': 'Bulgaria', 'facility': 'MBAL Sv. 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{'zip': '67172', 'city': 'Miroslav', 'country': 'Czechia', 'facility': 'MUDr. Ilona Pavlisova, s.r.o.', 'geoPoint': {'lat': 48.94767, 'lon': 16.31252}}, {'zip': '29301', 'city': 'Mlada Boreslav', 'country': 'Czechia', 'facility': 'MUDr. Michaela Baerova'}, {'zip': '547 01', 'city': 'Náchod', 'country': 'Czechia', 'facility': 'MUDr. Pavla Shihatova', 'geoPoint': {'lat': 50.4167, 'lon': 16.16289}}, {'zip': '741 01', 'city': 'Nový Jičín', 'country': 'Czechia', 'facility': 'MUDr. Dusan Velart', 'geoPoint': {'lat': 49.59438, 'lon': 18.01028}}, {'zip': '741 01', 'city': 'Nový Jičín', 'country': 'Czechia', 'facility': 'MUDr. Sarka Hofrova', 'geoPoint': {'lat': 49.59438, 'lon': 18.01028}}, {'zip': '288 01', 'city': 'Nymburk', 'country': 'Czechia', 'facility': 'MUDr. Sarka Klimesova', 'geoPoint': {'lat': 50.18605, 'lon': 15.04167}}, {'zip': '779 00', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'MUDr. Ondrej Sobotik', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '735 14', 'city': 'Orlová - Lutyně', 'country': 'Czechia', 'facility': 'MUDr. RAdoslav Alexa'}, {'zip': '700 30', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'MUDr. Milena Sramkova', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '70868', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'MUDr. Jana Balounova', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '70868', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'MUDr. Jana Kocianova', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '700 30', 'city': 'Ostrava, Bělský Les', 'country': 'Czechia', 'facility': 'Plicní-ambulance Terezie Janásková, s.r.o', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '530 02', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'MUDr. Tereza Dobesova Aximed s.r.o.', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '530 09', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'MUDr. Miluse Zitkova', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, 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