Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT01154127
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2010-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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': 'D006024', 'term': 'Glycopyrrolate'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': {'description': 'All patients as randomized who received at least one dose of study drug are included in the safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'NVA237', 'description': 'Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days\n\nPeriod 2: Matching placebo via NEOHALER inhaler device for 21 days\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.', 'otherNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days\n\nPeriod 2: Matching placebo via NEOHALER inhaler device for 21 days\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.', 'otherNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '505.63', 'groupId': 'OG000', 'lowerLimit': '466.59', 'upperLimit': '544.68'}, {'value': '416.70', 'groupId': 'OG001', 'lowerLimit': '377.76', 'upperLimit': '455.64'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 21', 'description': 'SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.'}, {'type': 'SECONDARY', 'title': 'Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'groupId': 'OG000', 'lowerLimit': '2.15', 'upperLimit': '2.31'}, {'value': '2.02', 'groupId': 'OG001', 'lowerLimit': '1.95', 'upperLimit': '2.08'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 21', 'description': 'Isotime is the last matching timepoint in the submaximal exercise tolerance test (SMETT) at which for both periods the patient has a test result. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting primary the PD assessment.'}, {'type': 'SECONDARY', 'title': 'Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'classes': [{'title': 'IC at peak (Spirometry), Day 21 (n = 93, 90)', 'categories': [{'measurements': [{'value': '2.22', 'groupId': 'OG000', 'lowerLimit': '2.16', 'upperLimit': '2.28'}, {'value': '2.03', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '2.10'}]}]}, {'title': 'IC at rest (Bodybox) Day 21 (n= 97, 96)', 'categories': [{'measurements': [{'value': '2.49', 'groupId': 'OG000', 'lowerLimit': '2.40', 'upperLimit': '2.59'}, {'value': '2.26', 'groupId': 'OG001', 'lowerLimit': '2.17', 'upperLimit': '2.35'}]}]}, {'title': 'IC at rest (Spirometry), Day 21 (n= 98, 96)', 'categories': [{'measurements': [{'value': '2.39', 'groupId': 'OG000', 'lowerLimit': '2.33', 'upperLimit': '2.45'}, {'value': '2.17', 'groupId': 'OG001', 'lowerLimit': '2.10', 'upperLimit': '2.23'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 21', 'description': 'IC at peak was observed using spirometry. However, two different methodologies (whole body plethysmography (Bodybox) and spirometry) were used to observe IC at rest.\n\nThe analysis of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.', 'unitOfMeasure': 'Litres', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. "n" indicates number of participants with observation at each time-point.'}, {'type': 'SECONDARY', 'title': 'Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'classes': [{'title': 'FEV1 at peak, Day 21', 'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '1.64'}, {'value': '1.35', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': '1.39'}]}]}, {'title': 'FEV1 at trough, Day 21', 'categories': [{'measurements': [{'value': '1.44', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '1.48'}, {'value': '1.33', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '1.37'}]}]}, {'title': 'FVC at peak, Day 21', 'categories': [{'measurements': [{'value': '3.37', 'groupId': 'OG000', 'lowerLimit': '3.30', 'upperLimit': '3.44'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '3.06'}]}]}, {'title': 'FVC at trough, Day 21', 'categories': [{'measurements': [{'value': '3.17', 'groupId': 'OG000', 'lowerLimit': '3.11', 'upperLimit': '3.23'}, {'value': '2.96', 'groupId': 'OG001', 'lowerLimit': '2.90', 'upperLimit': '3.02'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 21', 'description': 'FEV1 is the amount of air that can be exhaled in one second. FEV1 was measured with spirometry conducted according to internationally accepted standards.\n\nFVC is the volume of air that can forcibly be blown out after full inspiration and is used in spirometry tests.\n\nThe trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period).\n\nThe analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.', 'unitOfMeasure': 'Litres', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.'}, {'type': 'SECONDARY', 'title': 'Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'classes': [{'title': 'SVC at trough, Day 21 (n= 98, 96)', 'categories': [{'measurements': [{'value': '3.21', 'groupId': 'OG000', 'lowerLimit': '3.14', 'upperLimit': '3.27'}, {'value': '3.14', 'groupId': 'OG001', 'lowerLimit': '3.07', 'upperLimit': '3.21'}]}]}, {'title': 'SVC at peak, Day 21 (n= 97, 96)', 'categories': [{'measurements': [{'value': '3.40', 'groupId': 'OG000', 'lowerLimit': '3.33', 'upperLimit': '3.47'}, {'value': '3.14', 'groupId': 'OG001', 'lowerLimit': '3.07', 'upperLimit': '3.21'}]}]}, {'title': 'TLC at trough, Day 21 (n= 98, 96)', 'categories': [{'measurements': [{'value': '6.99', 'groupId': 'OG000', 'lowerLimit': '6.88', 'upperLimit': '7.09'}, {'value': '7.17', 'groupId': 'OG001', 'lowerLimit': '7.07', 'upperLimit': '7.28'}]}]}, {'title': 'TLC at peak, Day 21 (n= 97, 96)', 'categories': [{'measurements': [{'value': '6.86', 'groupId': 'OG000', 'lowerLimit': '6.75', 'upperLimit': '6.97'}, {'value': '7.10', 'groupId': 'OG001', 'lowerLimit': '6.99', 'upperLimit': '7.21'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 21', 'description': 'Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs.\n\nTotal Lung Capacity (TLC) is the best vital capacity plus residual volume. Whole body plethysmography (Bodybox) was used to measure SVC and TLC. The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period).', 'unitOfMeasure': 'Litres', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. "n" indicates number of participants with observation at each time-point.'}, {'type': 'SECONDARY', 'title': 'Specific Airways Conductance (SGaw)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'classes': [{'title': 'SGaw at trough, Day 21 (n= 98, 96)', 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.45', 'upperLimit': '0.51'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '0.43'}]}]}, {'title': 'SGaw at peak, Day 21 (n= 97, 96)', 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.70'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.46'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 21', 'description': 'SGaw is a measure of how hard it is to get air into the lungs, measured by (Sec(-1)\\*kP). Whole body plethysmography (Bodybox) was used to measure SGaw.\n\nThe analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.', 'unitOfMeasure': 'litres/(Second*kpa); kpa = kilopascal', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.'}, {'type': 'SECONDARY', 'title': 'Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.64', 'groupId': 'OG000', 'lowerLimit': '5.05', 'upperLimit': '6.23'}, {'value': '6.80', 'groupId': 'OG001', 'lowerLimit': '6.20', 'upperLimit': '7.39'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 21', 'description': 'The Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).\n\nA reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.'}, {'type': 'SECONDARY', 'title': 'Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.21', 'groupId': 'OG000', 'lowerLimit': '5.67', 'upperLimit': '6.76'}, {'value': '7.05', 'groupId': 'OG001', 'lowerLimit': '6.51', 'upperLimit': '7.60'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 21', 'description': 'The modified Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of leg discomfort before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).\n\nA reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.'}, {'type': 'SECONDARY', 'title': 'Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '490.92', 'groupId': 'OG000', 'lowerLimit': '458.45', 'upperLimit': '523.38'}, {'value': '447.78', 'groupId': 'OG001', 'lowerLimit': '415.09', 'upperLimit': '480.48'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1', 'description': 'SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise.\n\nThe analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.', 'unitOfMeasure': 'Seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NVA237 Followed by Placebo', 'description': 'Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.\n\nPeriod 2: Matching placebo via NEOHALER inhaler device for 21 days\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'FG001', 'title': 'Placebo Followed by NVA237', 'description': 'Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days\n\nPeriod 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}], 'periods': [{'title': 'Period 1 (21 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Washout (14 - 28 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Abnormal Test Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (21 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NVA237 Followed by Placebo', 'description': 'Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.\n\nPeriod 2: Matching placebo via NEOHALER inhaler device for 21 days\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'BG001', 'title': 'Placebo Followed by NVA237', 'description': 'Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days\n\nPeriod 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '8.50', 'groupId': 'BG000'}, {'value': '59.7', 'spread': '8.78', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '8.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-10', 'studyFirstSubmitDate': '2010-06-29', 'resultsFirstSubmitDate': '2012-02-08', 'studyFirstSubmitQcDate': '2010-06-29', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-10', 'studyFirstPostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment', 'timeFrame': 'Day 21', 'description': 'SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.'}], 'secondaryOutcomes': [{'measure': 'Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment', 'timeFrame': 'Day 21', 'description': 'Isotime is the last matching timepoint in the submaximal exercise tolerance test (SMETT) at which for both periods the patient has a test result. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.'}, {'measure': 'Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment', 'timeFrame': 'Day 21', 'description': 'IC at peak was observed using spirometry. However, two different methodologies (whole body plethysmography (Bodybox) and spirometry) were used to observe IC at rest.\n\nThe analysis of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.'}, {'measure': 'Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)', 'timeFrame': 'Day 21', 'description': 'FEV1 is the amount of air that can be exhaled in one second. FEV1 was measured with spirometry conducted according to internationally accepted standards.\n\nFVC is the volume of air that can forcibly be blown out after full inspiration and is used in spirometry tests.\n\nThe trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period).\n\nThe analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.'}, {'measure': 'Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)', 'timeFrame': 'Day 21', 'description': 'Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs.\n\nTotal Lung Capacity (TLC) is the best vital capacity plus residual volume. Whole body plethysmography (Bodybox) was used to measure SVC and TLC. The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period).'}, {'measure': 'Specific Airways Conductance (SGaw)', 'timeFrame': 'Day 21', 'description': 'SGaw is a measure of how hard it is to get air into the lungs, measured by (Sec(-1)\\*kP). Whole body plethysmography (Bodybox) was used to measure SGaw.\n\nThe analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.'}, {'measure': 'Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment', 'timeFrame': 'Day 21', 'description': 'The Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).\n\nA reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.'}, {'measure': 'Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment', 'timeFrame': 'Day 21', 'description': 'The modified Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of leg discomfort before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).\n\nA reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.'}, {'measure': 'Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1', 'timeFrame': 'Day 1', 'description': 'SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise.\n\nThe analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.'}]}, 'conditionsModule': {'keywords': ['NVA237', 'COPD', 'bronchodilator', 'exercise endurance'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '22973092', 'type': 'DERIVED', 'citation': 'Beeh KM, Singh D, Di Scala L, Drollmann A. Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis. 2012;7:503-13. doi: 10.2147/COPD.S32451. Epub 2012 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who signed an Informed Consent Form prior to initiation of any study-related procedure\n* Patients with moderate to severe stable COPD (clinical diagnosis in compliance with GOLD 2008)\n* Current or ex-smokers with a smoking history ≥ 10 pack years. (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.).\n* Patients with a post-bronchodilator FEV1 ≥ 40 and \\< 70% of the predicted normal, and postbronchodilator FEV1/FVC \\< 0.7 during screening. (Post referred to the highest post-bronchodilator value after inhalation of 80 μg ipratropium bromide)\n* Increase in FEV1 from pre- to post-bronchodilator assessment of ≥ 5%\n\nExclusion Criteria:\n\n* Pregnant women or nursing mothers\n* Women of child-bearing potential\n* Patients who had a COPD exacerbation (whether hospitalized or not) in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4\n* Patients who had a lower respiratory tract infection in the 6 weeks prior to Visit 1\n* Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia\n* Patients with resting (5 min) oxygen SaO2 (or SpO2) saturation on room air of \\< 85%\n* Patients with a maximum workload (Wmax) value \\< 20 W (as determined by the incremental cycle endurance test) at Visit 2.\n* Patients whose exercise endurance time at sub-maximal workload was above 25 min at baseline\n* Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would have been at potential risk if enrolled into the study\n* Patients with a history of long QT syndrome or whose QTc was prolonged (\\> 450 ms for males and \\> 470 ms females) at screening (Fredericia's correction)\n\nOther protocol-defined inclusion/exclusion criteria applied"}, 'identificationModule': {'nctId': 'NCT01154127', 'acronym': 'GLOW3', 'briefTitle': 'Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study to Assess the Effect of 50µg Inhaled NVA237 on Exercise Endurance in Patients With Moderate to Severe COPD', 'orgStudyIdInfo': {'id': 'CNVA237A2310'}, 'secondaryIdInfos': [{'id': '2010-018597-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NVA237 followed by Placebo', 'description': 'Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days\n\nPeriod 2: Matching placebo via NEOHALER inhaler device for 21 days\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.', 'interventionNames': ['Drug: NVA237', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo followed by NVA237', 'description': 'Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days\n\nPeriod 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days\n\nThe washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.\n\nSalbutamol (albuterol) was used as rescue medication throughout the study.', 'interventionNames': ['Drug: NVA237', 'Drug: Placebo']}], 'interventions': [{'name': 'NVA237', 'type': 'DRUG', 'description': '50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily', 'armGroupLabels': ['NVA237 followed by Placebo', 'Placebo followed by NVA237']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily', 'armGroupLabels': ['NVA237 followed by Placebo', 'Placebo followed by NVA237']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg Medical Research, 485 Simuel Road', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Woehrendamm', 'country': 'Germany', 'facility': 'Novartis Investigative Site'}, {'city': 'Verona', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}