Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-01 @ 10:16 AM
Study NCT ID:
NCT03003494
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2016-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
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': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Therapeutic success was assessed by a patient questionnaire at two time points. The respective answers were dependent on the condition of the patient at the completion. No objective assessment was performed due to the non-interventional study concept'}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until end of study, up to approx 6 weeks.', 'description': 'All safety analyses were based on the TS', 'eventGroups': [{'id': 'EG000', 'title': 'Spiolto Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines', 'otherNumAtRisk': 306, 'deathsNumAtRisk': 306, 'otherNumAffected': 0, 'seriousNumAtRisk': 306, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines'}], 'classes': [{'categories': [{'measurements': [{'value': '52.52', 'groupId': 'OG000', 'lowerLimit': '46.47', 'upperLimit': '58.51'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after approximately 6 weeks', 'description': 'Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome "physical functioning" is a sub-domain of the validated Short Form 36 (SF-36 ) and 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 sum of the scores of the 10 questions results 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 was standardized to a range of 0 to 100 using the following formula: \\[(sum of scale items - 10) \\* 100\\] / 20. Higher scores indicate better physical functioning.', 'unitOfMeasure': 'Percentage of Participants (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed PF-10 questionnaire at both study visits.'}, {'type': 'SECONDARY', 'title': 'The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '-60', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (visit 1) and after approx. week 6 (visit 2)', 'description': 'The change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the median for change from baseline values across all subjects was calculated.', 'unitOfMeasure': 'Unit on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines'}], 'classes': [{'title': 'Baseline (Visit 1) : PGE score 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Baseline (Visit 1) : PGE score 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Baseline (Visit 1) : PGE score 3', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Baseline (Visit 1) : PGE score 4', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Baseline (Visit 1) : PGE score 5', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Baseline (Visit 1) : PGE score 6', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Baseline (Visit 1) : PGE score 7', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Baseline (Visit 1) : PGE score 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (approx.) (Visit 2): Score 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (approx.) (Visit 2): Score 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (approx.) (Visit 2): Score 3', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (approx.) (Visit 2): Score 4', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (approx.) (Visit 2): Score 5', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (approx.) (Visit 2): Score 6', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (approx.) (Visit 2): Score 7', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (approx.) (Visit 2): Score 8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (visit 1) and after approx.week 6 (visit 2)', 'description': "The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Patient Overall Satisfaction With Spiolto® Respimat®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Questionnaire not completed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After approx. 6 weeks of treatment initiation', 'description': 'Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Inhaling From the Respimat® Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Questionnaire not completed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After approx. 6 weeks of treatment initiation', 'description': 'Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Handling of the Respimat® Inhalation Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Questionnaire not completed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After approx. 6 weeks of treatment initiation', 'description': 'Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spiolto Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Evaluable PF10 questionnaire at visit1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}]}], 'recruitmentDetails': 'Patient with chronic Obstructive Pulmonary Disease receiving treatment Spiolto® Respimat® were enrolled between July 2017 and May 2018.\n\n309 screened and 3 patient violated inclusion/exclusion criteria were excluded, 306 entered the trial', 'preAssignmentDetails': 'All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met. Physical Functioning patient questionnaire (PF10)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Spiolto Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '71.04', 'spread': '8.81', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '216', '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): The Treated set comprising all patients with informed consent, registration date and at least one documented administration of Spiolto® Respimat®.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-19', 'size': 337549, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-29T05:53', 'hasProtocol': False}, {'date': '2016-07-13', 'size': 485108, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-29T05:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2016-12-22', 'resultsFirstSubmitDate': '2019-07-29', 'studyFirstSubmitQcDate': '2016-12-22', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-27', 'studyFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)', 'timeFrame': 'after approximately 6 weeks', 'description': 'Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome "physical functioning" is a sub-domain of the validated Short Form 36 (SF-36 ) and 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 sum of the scores of the 10 questions results 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 was standardized to a range of 0 to 100 using the following formula: \\[(sum of scale items - 10) \\* 100\\] / 20. Higher scores indicate better physical functioning.'}], 'secondaryOutcomes': [{'measure': 'The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2', 'timeFrame': 'Baseline (visit 1) and after approx. week 6 (visit 2)', 'description': 'The change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the median for change from baseline values across all subjects was calculated.'}, {'measure': 'Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2', 'timeFrame': 'Baseline (visit 1) and after approx.week 6 (visit 2)', 'description': "The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent"}, {'measure': 'Patient Overall Satisfaction With Spiolto® Respimat®', 'timeFrame': 'After approx. 6 weeks of treatment initiation', 'description': 'Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).'}, {'measure': 'Patient Satisfaction With Inhaling From the Respimat® Device', 'timeFrame': 'After approx. 6 weeks of treatment initiation', 'description': 'Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)'}, {'measure': 'Patient Satisfaction With Handling of the Respimat® Inhalation Device', 'timeFrame': 'After approx. 6 weeks of treatment initiation', 'description': 'Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '32557394', 'type': 'DERIVED', 'citation': "Carone M, Pennisi A, D'Amato M, Donati AF, Ricci A, Scognamillo C, Chun L, Aliani M, Ronsivalle V, Pelaia G. Physical Functioning in Patients with Chronic Obstructive Pulmonary Disease Treated with Tiotropium/Olodaterol Respimat in Routine Clinical Practice in Italy. Pulm Ther. 2020 Dec;6(2):261-274. doi: 10.1007/s41030-020-00122-9. Epub 2020 Jun 18."}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to measure changes in physical functioning in chronic obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.', 'detailedDescription': 'Purpose:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '400 chronic obstructive pulmonary disease (COPD) patients will be enrolled in Pulmonology sites', '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 COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and therapeutic plan recommendation\n\nExclusion criteria:\n\n1. Patients with contraindications according to Spiolto® Respimat® Summary of Product Characteristics (SmPC)\n2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months\n3. Patients continuing LABA-Inhalative Corticosteroids (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'}, 'identificationModule': {'nctId': 'NCT03003494', 'acronym': 'OTIVACTO', 'briefTitle': 'Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy', 'orgStudyIdInfo': {'id': '1237.43'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spiolto® Respimat®', 'description': 'consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC', 'interventionNames': ['Drug: Spiolto® Respimat®']}], 'interventions': [{'name': 'Spiolto® Respimat®', 'type': 'DRUG', 'otherNames': ['INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO'], 'description': 'observations taken in a period of approximately 6 weeks', 'armGroupLabels': ['Spiolto® Respimat®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70021', 'city': 'Acquaviva Delle Fonti (BA)', 'country': 'Italy', 'facility': 'Ospedale Generale Regionale "Miulli"', 'geoPoint': {'lat': 40.89704, 'lon': 16.8433}}, {'zip': '82100', 'city': 'Benevento', 'country': 'Italy', 'facility': 'Azienda Ospedaliera G. 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