Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-25 @ 2:43 AM
Study NCT ID:
NCT02173769
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2014-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy
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}}, 'adverseEventsModule': {'timeFrame': 'From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Spiriva Respimat + Striverdi Respimat', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat', 'otherNumAtRisk': 1298, 'otherNumAffected': 0, 'seriousNumAtRisk': 1298, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Spiriva 18 mcg + Striverdi Respimat', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva 18 microgram plus Striverdi Respimat', 'otherNumAtRisk': 560, 'otherNumAffected': 0, 'seriousNumAtRisk': 560, 'seriousNumAffected': 12}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Gastroenteritis clostridial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Metastatic bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 560, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With "Therapeutic Success"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1726', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat'}], 'classes': [{'title': 'Therapy successful', 'categories': [{'measurements': [{'value': '48.90', 'groupId': 'OG000'}]}]}, {'title': 'Therapy not successful', 'categories': [{'measurements': [{'value': '51.10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4-6 weeks', 'description': 'Percentage of participants with "therapeutic success" defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks.\n\nThe PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis (FAS) which includes all patients enrolled in the study who did not violated any inclusion or exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Absolute Changes in the PF-10 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1726', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat'}], 'classes': [{'categories': [{'measurements': [{'value': '10.15', 'spread': '19.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-6 weeks', 'description': 'Absolute changes in the PF-10 score.\n\nThe PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'General Health of the Patient at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1853', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat'}], 'classes': [{'title': '1 (poor)', 'categories': [{'measurements': [{'value': '2.10', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '14.72', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '25.73', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '29.13', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '16.57', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '9.44', 'groupId': 'OG000'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '2.16', 'groupId': 'OG000'}]}]}, {'title': '8 (excellent)', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination.\n\nThe PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including patients with available PGE score at baseline'}, {'type': 'SECONDARY', 'title': 'General Health of the Patient After 4-6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1770', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat'}], 'classes': [{'title': '1 (poor)', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '5.48', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '13.67', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '22.60', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '25.08', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '22.09', 'groupId': 'OG000'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '8.25', 'groupId': 'OG000'}]}]}, {'title': '8 (excellent)', 'categories': [{'measurements': [{'value': '1.86', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-6 weeks', 'description': 'General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks.\n\nThe PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including patients with available PGE score at end of study visit'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction: Overall Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1773', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat'}], 'classes': [{'title': 'Very satisifed', 'categories': [{'measurements': [{'value': '25.21', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '42.13', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '13.53', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied or dissatisfied', 'categories': [{'measurements': [{'value': '9.70', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '4.29', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '4.06', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-6 weeks', 'description': 'Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.\n\nPatient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including patients with available satisfaction data'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction: Satisfaction With Inhaler', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1779', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat'}], 'classes': [{'title': 'Very satisifed', 'categories': [{'measurements': [{'value': '31.53', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '49.86', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '10.06', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied or dissatisfied', 'categories': [{'measurements': [{'value': '5.12', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '1.52', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-6 weeks', 'description': 'Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.\n\nPatient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including patients with available inhaler satisfaction data'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction: Satisfaction With Handling of Inhaler', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1778', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat'}], 'classes': [{'title': 'Very satisifed', 'categories': [{'measurements': [{'value': '31.44', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '49.32', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '11.25', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied or dissatisfied', 'categories': [{'measurements': [{'value': '5.06', 'groupId': 'OG000'}]}]}, {'title': 'Rather dissatisfied', 'categories': [{'measurements': [{'value': '1.57', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-6 weeks', 'description': 'Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.\n\nPatient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including patients with available handling of inhaler satisfaction data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1858'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1854'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'An open, prospective non-interventional study in patients with moderate to severe chronic obstructive pulmonary disease (COPD).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1858', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.41', 'spread': '10.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '770', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1088', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set which includes all patients with baseline visit data.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1845}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2014-06-24', 'resultsFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-02', 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With "Therapeutic Success"', 'timeFrame': 'Baseline and 4-6 weeks', 'description': 'Percentage of participants with "therapeutic success" defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks.\n\nThe PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.'}], 'secondaryOutcomes': [{'measure': 'Absolute Changes in the PF-10 Score', 'timeFrame': '4-6 weeks', 'description': 'Absolute changes in the PF-10 score.\n\nThe PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.'}, {'measure': 'General Health of the Patient at Baseline', 'timeFrame': 'Baseline', 'description': 'General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination.\n\nThe PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent).'}, {'measure': 'General Health of the Patient After 4-6 Weeks', 'timeFrame': '4-6 weeks', 'description': 'General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks.\n\nThe PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent).'}, {'measure': 'Patient Satisfaction: Overall Satisfaction', 'timeFrame': '4-6 weeks', 'description': 'Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.\n\nPatient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).'}, {'measure': 'Patient Satisfaction: Satisfaction With Inhaler', 'timeFrame': '4-6 weeks', 'description': 'Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.\n\nPatient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).'}, {'measure': 'Patient Satisfaction: Satisfaction With Handling of Inhaler', 'timeFrame': '4-6 weeks', 'description': 'Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.\n\nPatient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The decrease in physical activity due to increasing dyspnoea that over time leads to a steadily worsening condition and increasing restriction of physical functioning is a key problem for COPD patients and affects even the early stages.\n\nClinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a marked improvement in physical exercise capacity.\n\nHowever, there have so far been no data from the daily practice setting about everyday functioning on combination treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in patients requiring treatment with 2 long-acting bronchodilators.\n\nThe objective of this NIS is to measure changes in physical functioning as a surrogate for physical activity and exercise capacity in COPD patients on treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in routine daily treatment (so-called real life setting).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Female and male patients \\>= 40 years\n* COPD GOLD 2014 B - D\n* Treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat® acc. to the Summary of Product Characteristics (SmPC), no change of routine diagnostics and treatment\n* Signed informed consent form before inclusion into the non-interventional study (NIS)\n\nExclusion criteria:\n\n* Patients with contraindications acc. to the Summary of Product Characteristics (SmPC)\n* pregnant and breastfeeding women\n* patients who are taking part in a different non-interventional study (NIS) or an interventional clinical study at the same time are not to be enrolled'}, 'identificationModule': {'nctId': 'NCT02173769', 'briefTitle': 'Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'AKTIV: Changes in Physical Functioning in Patients With COPD During Therapy With a Combination of Spiriva® Respimat® + Striverdi® Respimat® or Spiriva® 18 Mikrogramm + Striverdi® Respimat®', 'orgStudyIdInfo': {'id': '1222.56'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with COPD', 'interventionNames': ['Drug: Spiriva® Respimat®', 'Drug: Striverdi® Respimat®']}], 'interventions': [{'name': 'Spiriva® Respimat®', 'type': 'DRUG', 'description': 'Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®', 'armGroupLabels': ['Adults with COPD']}, {'name': 'Striverdi® Respimat®', 'type': 'DRUG', 'description': 'Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®', 'armGroupLabels': ['Adults with COPD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aachen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 1', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Ahaus', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 2', 'geoPoint': {'lat': 52.07936, 'lon': 7.01344}}, {'city': 'Aichtal', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 3', 'geoPoint': {'lat': 48.62638, 'lon': 9.26315}}, {'city': 'Aldenhoven', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 4', 'geoPoint': {'lat': 50.9, 'lon': 6.28333}}, {'city': 'Alfeld', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 5', 'geoPoint': {'lat': 51.98382, 'lon': 9.81989}}, {'city': 'Altötting', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 6', 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'Auerbach', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 14', 'geoPoint': {'lat': 50.51155, 'lon': 12.40083}}, {'city': 'Augsburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 15', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Augsburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 16', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Aßlar', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 11', 'geoPoint': {'lat': 50.59163, 'lon': 8.46273}}, {'city': 'Bacharach', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 17', 'geoPoint': {'lat': 50.05725, 'lon': 7.76948}}, {'city': 'Bad Friedrichshall', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 18'}, {'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 19', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'city': 'Bad Langensalza', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 20', 'geoPoint': {'lat': 51.10771, 'lon': 10.646}}, {'city': 'Bad Lippspringe', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 21', 'geoPoint': {'lat': 51.78333, 'lon': 8.81683}}, {'city': 'Bad Lippspringe', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 22', 'geoPoint': {'lat': 51.78333, 'lon': 8.81683}}, {'city': 'Bad Reichenhall', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 23', 'geoPoint': {'lat': 47.72947, 'lon': 12.87819}}, {'city': 'Bad Sachsa', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 24', 'geoPoint': {'lat': 51.59499, 'lon': 10.55546}}, {'city': 'Bad Soden', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 25', 'geoPoint': {'lat': 50.28857, 'lon': 9.36404}}, {'city': 'Bad Soden-Salmünster', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 26', 'geoPoint': {'lat': 50.27574, 'lon': 9.36705}}, {'city': 'Bad Windsheim', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 27', 'geoPoint': {'lat': 49.50274, 'lon': 10.41539}}, {'city': 'Bad Wörishofen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 28', 'geoPoint': {'lat': 48.00674, 'lon': 10.59666}}, {'city': 'Baden-Baden', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 29', 'geoPoint': {'lat': 48.7606, 'lon': 8.23975}}, {'city': 'Balingen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 30', 'geoPoint': {'lat': 48.27525, 'lon': 8.85464}}, {'city': 'Beelitz-Heilstätten', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 31', 'geoPoint': {'lat': 52.25965, 'lon': 12.92662}}, {'city': 'Beelitz-Heilstätten', 'country': 'Germany', 'facility': 'Boehringer Ingelheim 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'Boehringer Ingelheim Investigational Site 39', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 40', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 41', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 42', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 43', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 44', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 45', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 46', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 47', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 48', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 49', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 50', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 51', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 52', 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'facility': 'Boehringer Ingelheim Investigational Site 59', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 60', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 61', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bernkastel', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 64'}, {'city': 'Biberach', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 65', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}, {'city': 'Biberach', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 66', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}, {'city': 'Biberach', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 67', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}, {'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 68', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 69', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Blankenheim', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 70', 'geoPoint': {'lat': 50.43333, 'lon': 6.65}}, {'city': 'Bocholt', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 71', 'geoPoint': {'lat': 51.83879, 'lon': 6.61531}}, {'city': 'Bocholt', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 72', 'geoPoint': {'lat': 51.83879, 'lon': 6.61531}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 73', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Bockenheim', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 74', 'geoPoint': {'lat': 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Investigational Site 81', 'geoPoint': {'lat': 51.52392, 'lon': 6.9285}}, {'city': 'Bottrop', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 82', 'geoPoint': {'lat': 51.52392, 'lon': 6.9285}}, {'city': 'Brandenburg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 83', 'geoPoint': {'lat': 52.41667, 'lon': 12.55}}, {'city': 'Braunschweig', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 84', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 85', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 86', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 87', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 88', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 89', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Bruchsal', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 90', 'geoPoint': {'lat': 49.12426, 'lon': 8.59804}}, {'city': 'Bruchweiler-Bärenbach', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 91', 'geoPoint': {'lat': 49.11667, 'lon': 7.8}}, {'city': 'Buchbach', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 92', 'geoPoint': {'lat': 48.31231, 'lon': 12.27343}}, {'city': 'Burg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 95', 'geoPoint': {'lat': 51.83448, 'lon': 14.14856}}, {'city': 'Burg', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site 96', 'geoPoint': 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