Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT02449018
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2015-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722274', 'term': 'icenticaftor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '8627781873', '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': 'Treatment-emergent adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 5, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'QBW251 300 mg Bid', 'description': 'QBW251 (28 day treatment period) and placebo (42 days, run-in and wash-out periods)', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 6, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Lung Clearance Index (LCI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.28', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.79', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 29', 'description': 'Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1 Pre-bronchodilator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FEV1 will be measured by spirometer before bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1 Post-bronchodilator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FEV1 will be measured by spirometer after bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FVC Pre Bronchodilator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FVC will be measured by spirometer before bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FVC Post- Bronchodilator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FVC will be measured by spirometer after bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in TLC will be measured by spirometry. Total lung capacity (TLC) is the volume in the lungs at maximal inflation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in RV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in RV will be measured by spirometry. Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FRC will be measured by spirometry. Functional residual capacity (FRC) is the volume in the lungs at the end-expiratory position. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DLCO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 29', 'description': 'Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood.', 'unitOfMeasure': 'ml/min/mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of QBW251 by TMax (0-8hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.27', 'groupId': 'OG000', 'lowerLimit': '0.983', 'upperLimit': '8.03'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.98', 'groupId': 'OG000', 'lowerLimit': '0.933', 'upperLimit': '7.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1, Day 28', 'description': 'Tmax is the time to reach the maximum concentration after drug administration.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of QBW251 by CMax (0-8hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1250', 'spread': '840', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1640', 'spread': '916', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 28', 'description': 'Cmax is the observed maximum plasma concentration following drug administration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of QBW251 by AUClast (0-8hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3830', 'spread': '3280', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6840', 'spread': '4490', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 28', 'description': 'AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.', 'unitOfMeasure': 'hr×ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of QBW251 by AUC0-12h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'timeFrame': 'Day 1, Day 28', 'description': 'AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set: included all patients with at least one available valid PK concentration measurement. Due to practicalities of study conduct PK samples were collected only up to 8 hours. As a result, from noncompartmental analysis AUClast was not calculated up to 12 hours after dosing So this data is not available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Abnormal laboratory value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'QBW251', 'description': 'QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo (70 days, run-in, treatment and wash-out periods)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '6.61', 'groupId': 'BG000'}, {'value': '64.9', 'spread': '7.55', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '6.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'dispFirstSubmitDate': '2017-11-08', 'completionDateStruct': {'date': '2017-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2015-03-30', 'dispFirstSubmitQcDate': '2017-11-08', 'resultsFirstSubmitDate': '2018-01-18', 'studyFirstSubmitQcDate': '2015-05-19', 'dispFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-02', 'studyFirstPostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Lung Clearance Index (LCI)', 'timeFrame': 'Baseline and Day 29', 'description': 'Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FEV1 Pre-bronchodilator', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FEV1 will be measured by spirometer before bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.'}, {'measure': 'Change From Baseline in FEV1 Post-bronchodilator', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FEV1 will be measured by spirometer after bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.'}, {'measure': 'Change From Baseline in FVC Pre Bronchodilator', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FVC will be measured by spirometer before bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator'}, {'measure': 'Change From Baseline in FVC Post- Bronchodilator', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FVC will be measured by spirometer after bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator'}, {'measure': 'Change From Baseline in TLC', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in TLC will be measured by spirometry. Total lung capacity (TLC) is the volume in the lungs at maximal inflation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.'}, {'measure': 'Change From Baseline in RV', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in RV will be measured by spirometry. Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.'}, {'measure': 'Change From Baseline in FRC', 'timeFrame': 'Day 29', 'description': 'Change From Baseline to Day 29 in FRC will be measured by spirometry. Functional residual capacity (FRC) is the volume in the lungs at the end-expiratory position. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.'}, {'measure': 'Change From Baseline in DLCO', 'timeFrame': 'Day 29', 'description': 'Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood.'}, {'measure': 'Plasma Concentration of QBW251 by TMax (0-8hours)', 'timeFrame': 'Day 1, Day 28', 'description': 'Tmax is the time to reach the maximum concentration after drug administration.'}, {'measure': 'Plasma Concentration of QBW251 by CMax (0-8hours)', 'timeFrame': 'Day 1, Day 28', 'description': 'Cmax is the observed maximum plasma concentration following drug administration.'}, {'measure': 'Plasma Concentration of QBW251 by AUClast (0-8hours)', 'timeFrame': 'Day 1, Day 28', 'description': 'AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.'}, {'measure': 'Plasma Concentration of QBW251 by AUC0-12h', 'timeFrame': 'Day 1, Day 28', 'description': 'AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD,', 'chronic bronchitis,', 'inflammation,', 'airway,', 'LCI,', 'pulmonary function test,', 'lung function,', 'controlled clinical trial,', 'randomized,', 'airflow,', 'smoker'], 'conditions': ['Chronic Obstructive Pulmonary Disease, COPD']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=223', 'label': 'A Plain Language Trial Summary is available on novartisclinicatrials.com'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonary disease (COPD); Must have clinical diagnosis of chronic bronchitis; Must be either a current smoker (smoked ≤ 1 pack per day on average for the last 3 months with at least a 10 pack year smoking history) OR an ex-smoker with at least a 10 pack year smoking history; Exclusion Criteria: Must not be receiving chronic, daily, systemic steroids; Must not have severe emphysema (determined by HRCT); Must not have had a COPD exacerbation or respiratory tract infection requiring antibiotics or oral steroids or hospitalization within 6 weeks of screening; Must not be pregnant or nursing or a woman of child bearing potential; Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02449018', 'briefTitle': 'A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Doses of QBW251 in Patients With COPD', 'orgStudyIdInfo': {'id': 'CQBW251X2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QBW251', 'description': 'QBW251 will be provided to participants during 70 days', 'interventionNames': ['Drug: QBW251']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be provided to participants during 70 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'QBW251', 'type': 'DRUG', 'description': 'QBW251 capsule(s) taken orally twice per day', 'armGroupLabels': ['QBW251']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsule(s) taken orally twice per day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '28152', 'city': 'Shelby', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.29235, 'lon': -81.53565}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '29681', 'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29379', 'city': 'Union', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.71541, 'lon': -81.62371}}, {'zip': '90-153', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '55-050', 'city': 'Sobótka', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.89992, 'lon': 16.74441}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}