Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-27 @ 8:41 PM
Study NCT ID:
NCT02720757
Status:
TERMINATED
Last Update Posted:
2019-04-16
First Post:
2016-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan', 'United States']}, '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': 'C000611386', 'term': 'tiotropium-olodaterol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The impact and the interpretation of this non-interventional (NIS) data are limited due to the non-interventional study concept'}}, 'adverseEventsModule': {'timeFrame': 'Data to be collected from signing the informed consent onwards until the end of the study; up to 6 weeks', 'description': 'The following had to be collected from signing the informed consent onwards until the end of the study:\n\n* all Adverse drug reactions (ADRs) (serious and non-serious), related to Spiolto® Respimat®\n* all Adverse Events with fatal outcome (serious adverse events).\n\nTreated set is the population set used for reporting Adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Tiotropium + Olodaterol FDC', 'description': 'Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.\n\nTiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 0, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol FDC', 'description': 'Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.\n\nTiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use'}], 'classes': [{'categories': [{'measurements': [{'value': '44.90', 'groupId': 'OG000', 'lowerLimit': '32.23', 'upperLimit': '54.78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)', 'description': '"Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100\\*(sum-10)/20.\n\nPercentage of patients with therapeutic success after approximately 6 weeks after baseline are presented', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Patients that were enrolled, registered and received at least one dose of treatment with Spiolto® Respimat® and had baseline and week 6 visit documented as well as completed all questionnaires were included in FAS'}, {'type': 'SECONDARY', 'title': 'Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol FDC', 'description': 'Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.\n\nTiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use'}], 'classes': [{'categories': [{'measurements': [{'value': '7.64', 'spread': '17.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)', 'description': 'Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2.\n\nPF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100\\*(sum-10)/20.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': "General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol FDC', 'description': 'Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.\n\nTiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use'}], 'classes': [{'title': 'Visit 1_score (2)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2_score (2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1_score (3)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2_score (3)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1_score (4)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2_score (4)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1_score (5)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2_score (5)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1_score (6)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2_score (6)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1_score (7)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2_score (7)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1_score (8)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2_score (8)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)', 'description': "The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation.\n\nCount of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol FDC', 'description': 'Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.\n\nTiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'title': '107', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'title': '107', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'title': '107', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'title': '107', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'title': '107', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'title': '107', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'title': '107', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (approx. 6 weeks post baseline)', 'description': 'A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.\n\nCount of patients with divisions from very dissatisfied to very satisfied are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol FDC', 'description': 'Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.\n\nTiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (approx. 6 weeks post baseline)', 'description': 'A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.\n\nCount of patients with divisions from very dissatisfied to very satisfied are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiotropium + Olodaterol FDC', 'description': 'Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.\n\nTiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (approx. 6 weeks post baseline)', 'description': 'A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.\n\nCount of patients with divisions from very dissatisfied to very satisfied are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tiotropium + Olodaterol FDC', 'description': 'Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.\n\nTiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Loss of contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Informed consent withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Patients wish to withdraw', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'General exclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This was an open-label observational study conducted in 6 countries, enrolling consented Chronic Obstructive Pulmonary Disorder (COPD) patients who received treatment with Spiolto® Respimat® according to the approved summary of product characteristics (SmPc).', 'preAssignmentDetails': 'Patients were enrolled consecutively and were followed over an observational period of approximately 6 weeks, which was the average time between two medical consultations'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tiotropium + Olodaterol FDC', 'description': 'Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.\n\nTiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.81', 'spread': '9.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', '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): Patients that were enrolled, registered and received at least one dose of Spiolto® Respimat® were included in the Treated Set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-21', 'size': 306847, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-13T07:42', 'hasProtocol': True}, {'date': '2017-08-25', 'size': 246489, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-13T07:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Recruitment failure', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2016-03-03', 'resultsFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-15', 'studyFirstPostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline', 'timeFrame': 'Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)', 'description': '"Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100\\*(sum-10)/20.\n\nPercentage of patients with therapeutic success after approximately 6 weeks after baseline are presented'}], 'secondaryOutcomes': [{'measure': 'Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)', 'timeFrame': 'Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)', 'description': 'Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2.\n\nPF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100\\*(sum-10)/20.'}, {'measure': "General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)", 'timeFrame': 'Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)', 'description': "The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation.\n\nCount of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2."}, {'measure': 'Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction', 'timeFrame': 'Visit 2 (approx. 6 weeks post baseline)', 'description': 'A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.\n\nCount of patients with divisions from very dissatisfied to very satisfied are presented.'}, {'measure': 'Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device', 'timeFrame': 'Visit 2 (approx. 6 weeks post baseline)', 'description': 'A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.\n\nCount of patients with divisions from very dissatisfied to very satisfied are presented.'}, {'measure': 'Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device', 'timeFrame': 'Visit 2 (approx. 6 weeks post baseline)', 'description': 'A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.\n\nCount of patients with divisions from very dissatisfied to very satisfied are presented.'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '34394782', 'type': 'DERIVED', 'citation': 'Spielmanns M, Tamm M, Schildge S, Valipour A. Swiss Experience in Therapy With Dual Bronchodilation in Chronic Obstructive Pulmonary Disease in Relation to Self-Reported Physical Functionality. J Clin Med Res. 2021 Jul;13(7):392-402. doi: 10.14740/jocmr4542. Epub 2021 Jul 28.'}]}, 'descriptionModule': {'briefSummary': "The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.\n\nA secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto® Respimat® at Visit 2."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic Obstructive Pulmonary Disease (COPD) patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Written informed consent prior to participation\n2. Female and male patients = 40 years of age\n3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation\n\nExclusion criteria:\n\n1. Patients with contraindications according to Spiolto® Respimat® SmPC\n2. Patients who have been treated with a Long-acting beta2 adrenoceptor agonist\\\\Long-acting muscarinic antagonist (LABA/LAMA) combination (free and fixed dose) in the previous 6 weeks.\n3. Patients continuing Long-acting beta2 adrenoceptor agonist Inhalative Corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists\n4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks\n5. Pregnancy and lactation\n6. Patients currently listed for lung transplantation\n7. Current participation in any clinical trial or any other non-interventional study of a drug or device Further exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02720757', 'briefTitle': 'Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice', 'orgStudyIdInfo': {'id': '1237.45'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spiolto Respimat', 'description': 'COPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines', 'interventionNames': ['Drug: Spiolto Respimat']}], 'interventions': [{'name': 'Spiolto Respimat', 'type': 'DRUG', 'description': 'Tiotropium bromide + Olodaterol', 'armGroupLabels': ['Spiolto Respimat']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Belgium'}, {'city': 'Multiple Locations', 'country': 'Denmark'}, {'city': 'Multiple Locations', 'country': 'Luxembourg'}, {'city': 'Multiple Locations', 'country': 'Netherlands'}, {'city': 'One Or Multiple Investigational Sites', 'country': 'Portugal'}, {'city': 'One Or Multiple Investigational Site', 'country': 'Sweden'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}