Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-04-20 @ 12:18 PM
Study NCT ID:
NCT02442206
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554862', 'term': 'indacaterol-glycopyrronium combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'For the study duration of about 13 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'QVA149 (110/50)', 'description': 'QVA149 (110/50)', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 27, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 17, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'All Patients', 'description': 'All Patients', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 40, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Left Ventricular End-diastolic Volume (LVEDV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'categories': [{'measurements': [{'value': '11.873', 'spread': '14.3215', 'groupId': 'OG000'}, {'value': '-0.954', 'spread': '12.2463', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.270', 'ciLowerLimit': '6.209', 'ciUpperLimit': '14.331', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': "Left ventricular enddiastolic volume (LVEDV) is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI.", 'unitOfMeasure': 'ML', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid LV EDV value at both baseline and post-baseline in a period were included'}, {'type': 'SECONDARY', 'title': 'Change in Forced Expiratory Volume in One Second (FEV1).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.168', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.49', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': 'Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by spirometry.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Change in Forced Vital Capacity (FVC).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '0.434', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.293', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.80', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': 'Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Change in Inspiratory Capacity (IC) at Each Time-point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'categories': [{'measurements': [{'value': '0.475', 'spread': '0.3284', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.2388', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.446', 'ciLowerLimit': '0.352', 'ciUpperLimit': '0.541', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': 'Inspiratory capacity (IC) was defined as the mean of the maximum IC over 3 values measured by bodyplethysmography according to internationally accepted standards.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Change in Total Lung Capacity (TLC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.181', 'spread': '0.3408', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.3618', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.177', 'ciLowerLimit': '-0.285', 'ciUpperLimit': '-0.070', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': 'Total Lung Capacity (TLC) will be calculated from the mean Functional Residual Capacity (FRC) plus the highest value of the Inspiratory Capacity, both measured by body plethymography according to internationally accepted standards.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Change in Residual Volume (RVol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.757', 'spread': '0.5833', 'groupId': 'OG000'}, {'value': '0.012', 'spread': '0.5141', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.751', 'ciLowerLimit': '-0.925', 'ciUpperLimit': '-0.577', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': 'Residual Volume (RVol) will be calculated from the value of Total Lung Capacity (TLC) minus the highest value of the Slow Vital Capacity, both measured by body plethymography according to internationally accepted standards.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Change in Specific Airway Resistance (sRaw)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.887', 'spread': '1.0979', 'groupId': 'OG000'}, {'value': '0.037', 'spread': '1.0383', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.639', 'ciLowerLimit': '-1.945', 'ciUpperLimit': '-1.332', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': 'Specific Airway Resistance (sRaw) will be documented as effective resistance (sReff) calculated as the median of five acceptable measurements. Values will be measured by body plethymography according to internationally accepted standards.', 'unitOfMeasure': 'kPa*s/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Change in Functional Residual Capacity (FRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.656', 'spread': '0.4602', 'groupId': 'OG000'}, {'value': '-0.015', 'spread': '0.4257', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.625', 'ciLowerLimit': '-0.761', 'ciUpperLimit': '-0.489', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': 'Functional Residual Capacity (FRC) will be calculated as the mean of three reproducible values as measured by body plethymography according to internationally accepted standards.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Change in Right Ventricular (RV) and Left Ventricular (LV) Ejection Fraction (EF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'title': 'LV-EF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.893', 'spread': '5.8486', 'groupId': 'OG000'}, {'value': '1.313', 'spread': '5.4261', 'groupId': 'OG001'}]}]}, {'title': 'RV-EF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.046', 'spread': '5.8746', 'groupId': 'OG000'}, {'value': '0.361', 'spread': '6.1936', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1420', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.209', 'ciLowerLimit': '-0.419', 'ciUpperLimit': '2.836', 'groupDescription': 'LV EF', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1732', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.131', 'ciLowerLimit': '-0.512', 'ciUpperLimit': '2.774', 'groupDescription': 'RV EF', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': "Right and left ventricular ejection fraction is the fraction of blood (in percent) pumped out of the heart's left and right ventricular chamber, respectively, with each heart beat and will be determined as measured by MRI.", 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Change in Left and Right Ventricular End-systolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'title': 'LV-ESV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.898', 'spread': '8.4565', 'groupId': 'OG000'}, {'value': '-2.283', 'spread': '8.1489', 'groupId': 'OG001'}]}]}, {'title': 'RV-ESV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.183', 'spread': '8.7063', 'groupId': 'OG000'}, {'value': '0.133', 'spread': '9.3370', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.241', 'ciLowerLimit': '0.066', 'ciUpperLimit': '4.417', 'groupDescription': 'LV ESV', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1236', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.095', 'ciLowerLimit': '-0.591', 'ciUpperLimit': '4.782', 'groupDescription': 'RV ESV', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': "Right ventricular end-systolic volume (RV-ESV) and left ventricular end-systolic volume (LV-ESV) is a measurement of the volume of blood in the heart's right and left ventricular chamber, respectively, at the end of the heart's contraction and will be determined as measured by MRI.", 'unitOfMeasure': 'ML', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Change in Right Ventricular Enddiastolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'categories': [{'measurements': [{'value': '12.323', 'spread': '13.9683', 'groupId': 'OG000'}, {'value': '1.758', 'spread': '14.7904', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.357', 'ciLowerLimit': '4.649', 'ciUpperLimit': '14.065', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 2', 'description': "Right ventricular end-diastolic volume is a measurement of the volume of blood in the heart's right ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI.", 'unitOfMeasure': 'ML', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}, {'type': 'SECONDARY', 'title': 'Cardiac Output at Each Time-point, Left and Right Ventricular Cardiac Output (LVCO and RVCO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'classes': [{'title': 'LVCO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.504', 'spread': '0.7919', 'groupId': 'OG000'}, {'value': '0.119', 'spread': '0.8970', 'groupId': 'OG001'}]}]}, {'title': 'RVCO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.517', 'spread': '0.8063', 'groupId': 'OG000'}, {'value': '0.144', 'spread': '0.9523', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.337', 'ciLowerLimit': '0.118', 'ciUpperLimit': '0.555', 'groupDescription': 'LVCO', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0182', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.281', 'ciLowerLimit': '0.050', 'ciUpperLimit': '0.512', 'groupDescription': 'RVCO', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'week 2', 'description': 'Cardiac output is calculated as the heart rate multiplied by the stroke volume (= difference between ventricular enddiastolic volume and endsystolic volume) that will be determined as measured by MRI.', 'unitOfMeasure': 'Liter/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence 1', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'FG001', 'title': 'Treatment Sequence 2', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COPD exacerbation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Sequence 1', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43'}, {'id': 'BG001', 'title': 'Treatment Sequence 2', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'spread': '8.00', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '7.80', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '7.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-09', 'size': 692147, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-27T08:38', 'hasProtocol': False}, {'date': '2016-04-20', 'size': 1666041, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-27T08:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-10', 'studyFirstSubmitDate': '2015-05-06', 'resultsFirstSubmitDate': '2018-04-27', 'studyFirstSubmitQcDate': '2015-05-08', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-27', 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Left Ventricular End-diastolic Volume (LVEDV)', 'timeFrame': 'Baseline, week 2', 'description': "Left ventricular enddiastolic volume (LVEDV) is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI."}], 'secondaryOutcomes': [{'measure': 'Change in Forced Expiratory Volume in One Second (FEV1).', 'timeFrame': 'Baseline, week 2', 'description': 'Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by spirometry.'}, {'measure': 'Change in Forced Vital Capacity (FVC).', 'timeFrame': 'Baseline, week 2', 'description': 'Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry.'}, {'measure': 'Change in Inspiratory Capacity (IC) at Each Time-point', 'timeFrame': 'Baseline, week 2', 'description': 'Inspiratory capacity (IC) was defined as the mean of the maximum IC over 3 values measured by bodyplethysmography according to internationally accepted standards.'}, {'measure': 'Change in Total Lung Capacity (TLC)', 'timeFrame': 'Baseline, week 2', 'description': 'Total Lung Capacity (TLC) will be calculated from the mean Functional Residual Capacity (FRC) plus the highest value of the Inspiratory Capacity, both measured by body plethymography according to internationally accepted standards.'}, {'measure': 'Change in Residual Volume (RVol)', 'timeFrame': 'Baseline, week 2', 'description': 'Residual Volume (RVol) will be calculated from the value of Total Lung Capacity (TLC) minus the highest value of the Slow Vital Capacity, both measured by body plethymography according to internationally accepted standards.'}, {'measure': 'Change in Specific Airway Resistance (sRaw)', 'timeFrame': 'Baseline, week 2', 'description': 'Specific Airway Resistance (sRaw) will be documented as effective resistance (sReff) calculated as the median of five acceptable measurements. Values will be measured by body plethymography according to internationally accepted standards.'}, {'measure': 'Change in Functional Residual Capacity (FRC)', 'timeFrame': 'Baseline, week 2', 'description': 'Functional Residual Capacity (FRC) will be calculated as the mean of three reproducible values as measured by body plethymography according to internationally accepted standards.'}, {'measure': 'Change in Right Ventricular (RV) and Left Ventricular (LV) Ejection Fraction (EF)', 'timeFrame': 'Baseline, week 2', 'description': "Right and left ventricular ejection fraction is the fraction of blood (in percent) pumped out of the heart's left and right ventricular chamber, respectively, with each heart beat and will be determined as measured by MRI."}, {'measure': 'Change in Left and Right Ventricular End-systolic Volume', 'timeFrame': 'Baseline, week 2', 'description': "Right ventricular end-systolic volume (RV-ESV) and left ventricular end-systolic volume (LV-ESV) is a measurement of the volume of blood in the heart's right and left ventricular chamber, respectively, at the end of the heart's contraction and will be determined as measured by MRI."}, {'measure': 'Change in Right Ventricular Enddiastolic Volume', 'timeFrame': 'Baseline, week 2', 'description': "Right ventricular end-diastolic volume is a measurement of the volume of blood in the heart's right ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI."}, {'measure': 'Cardiac Output at Each Time-point, Left and Right Ventricular Cardiac Output (LVCO and RVCO)', 'timeFrame': 'week 2', 'description': 'Cardiac output is calculated as the heart rate multiplied by the stroke volume (= difference between ventricular enddiastolic volume and endsystolic volume) that will be determined as measured by MRI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['QVA149, cardiac function, ventricular enddiastolic volume, hyperinflated COPD patients'], 'conditions': ['Chronic Obstructive Pulmonary Disease, COPD']}, 'referencesModule': {'references': [{'pmid': '30641027', 'type': 'DERIVED', 'citation': 'Vogel-Claussen J, Schonfeld CO, Kaireit TF, Voskrebenzev A, Czerner CP, Renne J, Tillmann HC, Berschneider K, Hiltl S, Bauersachs J, Welte T, Hohlfeld JM. Effect of Indacaterol/Glycopyrronium on Pulmonary Perfusion and Ventilation in Hyperinflated Patients with Chronic Obstructive Pulmonary Disease (CLAIM). A Double-Blind, Randomized, Crossover Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1086-1096. doi: 10.1164/rccm.201805-0995OC.'}, {'pmid': '29477448', 'type': 'DERIVED', 'citation': 'Hohlfeld JM, Vogel-Claussen J, Biller H, Berliner D, Berschneider K, Tillmann HC, Hiltl S, Bauersachs J, Welte T. Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial. Lancet Respir Med. 2018 May;6(5):368-378. doi: 10.1016/S2213-2600(18)30054-7. Epub 2018 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'This mechanistic study is a single-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and lung function parameters in hyperinflated COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with airflow limitation indicated by a post-bronchodilator FEV1 \\<80% of the predicted normal value and a post-bronchodilator FEV1/FVC\\<0.7\n* Current or ex-smokers who have a smoking history of at least 10 pack years.\n* Able and willing to give written informed consent\n* Hyperinflated patients with RVol\\>135% predicted\n\nExclusion Criteria:\n\n* Patients on LABA or LAMA treatment at Visit 1.\n* History of one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization 3 months prior to Visit 2.\n* More than one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within 6 months prior to Visit 2.\n* Patients who have clinically significant cardiovascular abnormalities, which could interfere with the assessment of the study treatment (such as but not limited to cardiac arrhythmias, heart failure with left ventricular ejection fraction \\<40% as determined by MRI scan, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, history of myocardial infarction 6 months prior to Visit 2)\n* Patients with a known history or current atrial fibrillation to be confirmed by ECG.\n* Patients with pacemaker, bypass or stent.\n* Patients whose QTcF measured at Visit 3 is \\>450 ms for males and \\>470 ms for females\n\nAdditional study-specific inclusion and exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02442206', 'acronym': 'CLAIM', 'briefTitle': 'Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blinded, Single-center, Placebo Controlled, Cross-over Study to Assess the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) on Cardiac Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'CQVA149ADE05'}, 'secondaryIdInfos': [{'id': '2014-004680-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 1', 'description': 'QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43', 'interventionNames': ['Drug: QVA149', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 2', 'description': 'Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43', 'interventionNames': ['Drug: QVA149', 'Drug: Placebo']}], 'interventions': [{'name': 'QVA149', 'type': 'DRUG', 'otherNames': ['Ultibro'], 'description': 'QVA149 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily', 'armGroupLabels': ['Treatment sequence 1', 'Treatment sequence 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to QVA140 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily', 'armGroupLabels': ['Treatment sequence 1', 'Treatment sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}