Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-26 @ 8:06 AM
Study NCT ID:
NCT01566604
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
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'}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler', 'otherNumAtRisk': 305, 'otherNumAffected': 81, 'seriousNumAtRisk': 305, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler', 'otherNumAtRisk': 154, 'otherNumAffected': 48, 'seriousNumAtRisk': 154, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cor pulmonale chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cerebral arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Thalamus haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trough Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '1.204', 'spread': '0.0135', 'groupId': 'OG000'}, {'value': '1.063', 'spread': '0.0160', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Baseline FEV1 was defined as the average of the -45 min and -15 min FEV1 values taken on day 1 prior to the first dose of study medication. Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. FEV1 was measured using central spirometry according to ATS/ERS standardization. Trough FEV1 was analyzed using a MIXED model for the full analysis set population. The model contained treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation of short acting bronchodilator, FEV1 45 min post inhalation of short acting bronchodilator and baseline inhaled corticosteroids (ICS) use as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, participants analyzed had both baseline and week 12 values.'}, {'type': 'SECONDARY', 'title': 'Transition Dyspnea Index (TDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'title': 'week 12 (n=288,141)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'week 26 (n=284,140)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 12, week 26', 'description': 'Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during the treatment period using the TDI, which captures changes from baseline. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort, and each domain scored from -3 (major deterioration) to +3 (major improvement), giving an overall score of -9 to +9. A negative score indicates deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Rescue Medication Use (Number of Puffs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.157', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.186', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': 'The participant recorded the rescue medication taken in an electronic diary between visits and in the spirometry device during study visits. Daytime and nighttime rescue medication use (number of puffs) over 26 weeks was analyzed.', 'unitOfMeasure': 'Number of puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': '24h Trough FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'title': 'Day 1 (n=289,151)', 'categories': [{'measurements': [{'value': '1.230', 'spread': '0.0084', 'groupId': 'OG000'}, {'value': '1.109', 'spread': '0.0104', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=281,143)', 'categories': [{'measurements': [{'value': '1.195', 'spread': '0.0140', 'groupId': 'OG000'}, {'value': '1.059', 'spread': '0.0171', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1, Week 26', 'description': 'Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. This was measured using central spirometry according to ATS/ERS standardization. This was analyzed using the same MIXED model as specified for the primary analysis.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1 or week 26.'}, {'type': 'SECONDARY', 'title': 'FEV1 and Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'title': 'FEV1, day 1, 5 min (n=281,143)', 'categories': [{'measurements': [{'value': '1.199', 'spread': '0.0060', 'groupId': 'OG000'}, {'value': '1.112', 'spread': '0.0072', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 1, 15 min (n=277,147)', 'categories': [{'measurements': [{'value': '1.245', 'spread': '0.0075', 'groupId': 'OG000'}, {'value': '1.116', 'spread': '0.0089', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 1, 30 min (n=283,145)', 'categories': [{'measurements': [{'value': '1.265', 'spread': '0.0076', 'groupId': 'OG000'}, {'value': '1.111', 'spread': '0.0090', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 1, 1 h (n=284,142)', 'categories': [{'measurements': [{'value': '1.295', 'spread': '0.0079', 'groupId': 'OG000'}, {'value': '1.124', 'spread': '0.0096', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 2, 23 h 15 min (n=267,137)', 'categories': [{'measurements': [{'value': '1.228', 'spread': '0.0086', 'groupId': 'OG000'}, {'value': '1.101', 'spread': '0.0108', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 2, 23 h 45 min min (n=272,140)', 'categories': [{'measurements': [{'value': '1.230', 'spread': '0.0092', 'groupId': 'OG000'}, {'value': '1.107', 'spread': '0.0112', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 29, -45 min (n=273,136)', 'categories': [{'measurements': [{'value': '1.208', 'spread': '0.0114', 'groupId': 'OG000'}, {'value': '1.079', 'spread': '0.0144', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 29, -15 min (n=280,142)', 'categories': [{'measurements': [{'value': '1.226', 'spread': '0.0113', 'groupId': 'OG000'}, {'value': '1.097', 'spread': '0.0142', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 29, 5 min (n=271,136)', 'categories': [{'measurements': [{'value': '1.240', 'spread': '0.0118', 'groupId': 'OG000'}, {'value': '1.097', 'spread': '0.0148', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 29, 15 min (n=272,135)', 'categories': [{'measurements': [{'value': '1.259', 'spread': '0.0117', 'groupId': 'OG000'}, {'value': '1.103', 'spread': '0.0147', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 29, 30 min (n=279,139)', 'categories': [{'measurements': [{'value': '1.272', 'spread': '0.0114', 'groupId': 'OG000'}, {'value': '1.105', 'spread': '0.0142', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 85, -45 min (n=269,130)', 'categories': [{'measurements': [{'value': '1.179', 'spread': '0.0118', 'groupId': 'OG000'}, {'value': '1.050', 'spread': '0.0147', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 85, -15 min (n=271,136)', 'categories': [{'measurements': [{'value': '1.190', 'spread': '0.0106', 'groupId': 'OG000'}, {'value': '1.052', 'spread': '0.0134', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 85, 5 min (n=262,130)', 'categories': [{'measurements': [{'value': '1.229', 'spread': '0.0119', 'groupId': 'OG000'}, {'value': '1.059', 'spread': '0.0147', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 85, 15 min (n=267,133)', 'categories': [{'measurements': [{'value': '1.246', 'spread': '0.0117', 'groupId': 'OG000'}, {'value': '1.061', 'spread': '0.0147', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 85, 30 min (n=273,137)', 'categories': [{'measurements': [{'value': '1.263', 'spread': '0.0129', 'groupId': 'OG000'}, {'value': '1.077', 'spread': '0.0156', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 85, 1 h (n=274,133)', 'categories': [{'measurements': [{'value': '1.275', 'spread': '0.0125', 'groupId': 'OG000'}, {'value': '1.079', 'spread': '0.0154', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 86, 23 h 15 min (n=261,127)', 'categories': [{'measurements': [{'value': '1.195', 'spread': '0.0146', 'groupId': 'OG000'}, {'value': '1.057', 'spread': '0.0175', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 86, 23 h 45 min (n=250,132)', 'categories': [{'measurements': [{'value': '1.203', 'spread': '0.0138', 'groupId': 'OG000'}, {'value': '1.067', 'spread': '0.0163', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 183, -45 min (n=262,135)', 'categories': [{'measurements': [{'value': '1.176', 'spread': '0.0148', 'groupId': 'OG000'}, {'value': '1.032', 'spread': '0.0176', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 183, - 15 min (n=265,135)', 'categories': [{'measurements': [{'value': '1.179', 'spread': '0.0130', 'groupId': 'OG000'}, {'value': '1.052', 'spread': '0.0165', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 183, 5 min (n=262,135)', 'categories': [{'measurements': [{'value': '1.220', 'spread': '0.0136', 'groupId': 'OG000'}, {'value': '1.055', 'spread': '0.0170', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 183, 15 min (n=261,140)', 'categories': [{'measurements': [{'value': '1.233', 'spread': '0.0139', 'groupId': 'OG000'}, {'value': '1.070', 'spread': '0.0169', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 183, 30 min (n=270,138)', 'categories': [{'measurements': [{'value': '1.265', 'spread': '0.0134', 'groupId': 'OG000'}, {'value': '1.071', 'spread': '0.0170', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 183, 1 h (n=263,135)', 'categories': [{'measurements': [{'value': '1.263', 'spread': '0.0137', 'groupId': 'OG000'}, {'value': '1.075', 'spread': '0.0168', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 184, 23 h 15 min (n=263,128)', 'categories': [{'measurements': [{'value': '1.197', 'spread': '0.0154', 'groupId': 'OG000'}, {'value': '1.068', 'spread': '0.0188', 'groupId': 'OG001'}]}]}, {'title': 'FEV1, day 184, 23 h 45 min (n=266,132)', 'categories': [{'measurements': [{'value': '1.196', 'spread': '0.0144', 'groupId': 'OG000'}, {'value': '1.058', 'spread': '0.0180', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 1, 5 min (n=281,143)', 'categories': [{'measurements': [{'value': '2.925', 'spread': '0.0184', 'groupId': 'OG000'}, {'value': '2.739', 'spread': '0.0220', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 1, 15 min (n=277,147)', 'categories': [{'measurements': [{'value': '2.992', 'spread': '0.0252', 'groupId': 'OG000'}, {'value': '2.759', 'spread': '0.0288', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 1, 30 min (n=283,145)', 'categories': [{'measurements': [{'value': '3.041', 'spread': '0.0235', 'groupId': 'OG000'}, {'value': '2.761', 'spread': '0.0280', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 1, 1 h (n=284,142)', 'categories': [{'measurements': [{'value': '3.044', 'spread': '0.0240', 'groupId': 'OG000'}, {'value': '2.755', 'spread': '0.0286', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 2, 23 h 15 min (n=267,137)', 'categories': [{'measurements': [{'value': '2.953', 'spread': '0.0275', 'groupId': 'OG000'}, {'value': '2.716', 'spread': '0.0326', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 2, 23 h 45 min (n=272,140)', 'categories': [{'measurements': [{'value': '2.981', 'spread': '0.0261', 'groupId': 'OG000'}, {'value': '2.744', 'spread': '0.0311', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 29, -45 min (n=273,136)', 'categories': [{'measurements': [{'value': '2.908', 'spread': '0.0324', 'groupId': 'OG000'}, {'value': '2.690', 'spread': '0.0375', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 29, -15 min (n=280,142)', 'categories': [{'measurements': [{'value': '2.927', 'spread': '0.0312', 'groupId': 'OG000'}, {'value': '2.730', 'spread': '0.0371', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 29, 5 min (n=271,136)', 'categories': [{'measurements': [{'value': '2.970', 'spread': '0.0292', 'groupId': 'OG000'}, {'value': '2.725', 'spread': '0.0353', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 29, 15 min (n=272,135)', 'categories': [{'measurements': [{'value': '2.993', 'spread': '0.0276', 'groupId': 'OG000'}, {'value': '2.751', 'spread': '0.0339', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 29, 30 min (n=279,139)', 'categories': [{'measurements': [{'value': '2.995', 'spread': '0.0287', 'groupId': 'OG000'}, {'value': '2.737', 'spread': '0.0341', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 85, -45 min (n=269,130)', 'categories': [{'measurements': [{'value': '2.854', 'spread': '0.0321', 'groupId': 'OG000'}, {'value': '2.611', 'spread': '0.0385', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 85, -15 min (n=271,136)', 'categories': [{'measurements': [{'value': '2.898', 'spread': '0.0318', 'groupId': 'OG000'}, {'value': '2.627', 'spread': '0.0373', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 85, 5 min (n=262,130)', 'categories': [{'measurements': [{'value': '2.927', 'spread': '0.0321', 'groupId': 'OG000'}, {'value': '2.633', 'spread': '0.0380', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 85, 15 min (n=267,133)', 'categories': [{'measurements': [{'value': '2.954', 'spread': '0.0328', 'groupId': 'OG000'}, {'value': '2.647', 'spread': '0.0387', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 85, 30 min (n=273,137)', 'categories': [{'measurements': [{'value': '2.977', 'spread': '0.0330', 'groupId': 'OG000'}, {'value': '2.695', 'spread': '0.0383', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 85, 1 h (n=274,133)', 'categories': [{'measurements': [{'value': '2.987', 'spread': '0.0347', 'groupId': 'OG000'}, {'value': '2.662', 'spread': '0.0400', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 86, 23 h 15 min (n=261,127)', 'categories': [{'measurements': [{'value': '2.908', 'spread': '0.0366', 'groupId': 'OG000'}, {'value': '2.612', 'spread': '0.0429', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 86, 23 h 45 min (n=250,132)', 'categories': [{'measurements': [{'value': '2.894', 'spread': '0.0360', 'groupId': 'OG000'}, {'value': '2.671', 'spread': '0.0412', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 183, -45 min (n=262,135)', 'categories': [{'measurements': [{'value': '2.858', 'spread': '0.0379', 'groupId': 'OG000'}, {'value': '2.604', 'spread': '0.0430', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 183, -15 min (n=265,135)', 'categories': [{'measurements': [{'value': '2.862', 'spread': '0.0359', 'groupId': 'OG000'}, {'value': '2.633', 'spread': '0.0415', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 183, 5 min (n=262,135)', 'categories': [{'measurements': [{'value': '2.927', 'spread': '0.0368', 'groupId': 'OG000'}, {'value': '2.672', 'spread': '0.0426', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 183, 15 min (n=261,140)', 'categories': [{'measurements': [{'value': '2.957', 'spread': '0.0365', 'groupId': 'OG000'}, {'value': '2.679', 'spread': '0.0420', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 183, 30 min (n=270,138)', 'categories': [{'measurements': [{'value': '2.988', 'spread': '0.0366', 'groupId': 'OG000'}, {'value': '2.707', 'spread': '0.0428', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 183, 1 h (n=263,135)', 'categories': [{'measurements': [{'value': '2.941', 'spread': '0.0401', 'groupId': 'OG000'}, {'value': '2.668', 'spread': '0.0453', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 184, 23 h 15 min (n=263,128)', 'categories': [{'measurements': [{'value': '2.869', 'spread': '0.0386', 'groupId': 'OG000'}, {'value': '2.664', 'spread': '0.0452', 'groupId': 'OG001'}]}]}, {'title': 'FVC, day 184, 23 h 45 min (n=266,132)', 'categories': [{'measurements': [{'value': '2.894', 'spread': '0.0402', 'groupId': 'OG000'}, {'value': '2.647', 'spread': '0.0472', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose', 'description': 'FEV1 and FVC were measured using central spirometry according to ATS/ERS standardization. Both were analyzed using the same MIXED model as specified for the primary analysis.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, e.g. day 1, 5 min; day 1, 15 min, etc..'}, {'type': 'SECONDARY', 'title': 'Peak FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'title': 'Day 1 (n=134,57)', 'categories': [{'measurements': [{'value': '1.376', 'spread': '0.0119', 'groupId': 'OG000'}, {'value': '1.183', 'spread': '0.0146', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=125,56)', 'categories': [{'measurements': [{'value': '1.347', 'spread': '0.0207', 'groupId': 'OG000'}, {'value': '1.140', 'spread': '0.0245', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=124,57)', 'categories': [{'measurements': [{'value': '1.308', 'spread': '0.0250', 'groupId': 'OG000'}, {'value': '1.112', 'spread': '0.0298', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1, week 12, week 26', 'description': 'Peak FEV1 was defined as the maximum FEV1 0-4 h post-dose. Peak Fev1 was measured at 45min and 15min pre-dose and up to 4h post dose at day 1, week 12 and week 26, using central spirometry according to ATS/ERS standardization. It was analyzed using the same MIXED model as specified for the primary analysis.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.'}, {'type': 'SECONDARY', 'title': 'Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'title': 'Day 1 (n=134,57)', 'categories': [{'measurements': [{'value': '1.311', 'spread': '0.0122', 'groupId': 'OG000'}, {'value': '1.117', 'spread': '0.0142', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=125,56)', 'categories': [{'measurements': [{'value': '1.286', 'spread': '0.0204', 'groupId': 'OG000'}, {'value': '1.080', 'spread': '0.0241', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=124,57)', 'categories': [{'measurements': [{'value': '1.243', 'spread': '0.0229', 'groupId': 'OG000'}, {'value': '1.046', 'spread': '0.0280', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1, week 12, week 26', 'description': 'The standardized (with respect to time) AUC for FEV1 was calculated between 5 min and 4h post morning dose at day 1, week 12 and week 26. The AUC (5 min-4 h) for FEV1 at each visit was analyzed using the same MIXED model as specified for the primary analysis.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'title': 'Total symptom (n=296,150)', 'categories': [{'measurements': [{'value': '-1.16', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '0.164', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory symptom', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.038', 'groupId': 'OG001'}]}]}, {'title': 'Cough symptom', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.036', 'groupId': 'OG001'}]}]}, {'title': 'Wheeze symptom', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.036', 'groupId': 'OG001'}]}]}, {'title': 'Sputum production', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.039', 'groupId': 'OG001'}]}]}, {'title': 'Sputum color', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Breathless symptom', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.035', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': "In an electronic diary, the participant responded to 6 questions twice daily to report on the degree of symptoms over the past 12 hours of the morning and evening. The questions covered the participant's degree of overall symptoms, and degrees of individual symptoms of coughing, wheezing, amount of sputum, color of sputum and breathlessness. Each question scored from 0 to 3 where 0 represented no symptom present and 3 represented the worst degree of that symptom. A negative change in symptom score indicates improvement.", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given symptom category, analyzed participants had both baseline and week 26 values.'}, {'type': 'SECONDARY', 'title': 'Time to First Moderate or Severe COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median time was not estimable due to the low number of participants with moderate or severe COPD exacerbations.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median time was not estimable due to the low number of participants with moderate or severe COPD exacerbations.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '26 weeks', 'description': 'A COPD exacerbation was defined as a worsening of the following two or more major symptoms for at least 2 consecutive days:1) dyspnea; 2) sputum volume; 3) sputum purulence; or defined as a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: 1) sore throat; 2) colds (nasal discharge and/or nasal congestion); 3) fever without other cause; 4) cough; 5) wheeze. COPD exacerbations were recorded in the patient diary and other source documents.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Moderate and Severe COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks', 'description': 'COPD exacerbations were recorded in the patient diary and other source documents. The rate of COPD exacerbations during the 26 week treatment period was analyzed using a generalized linear model assuming a negative binomial distribution.', 'unitOfMeasure': 'Number of exacerbations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': "The Total Score of the St George's Respiratory Questionnaire (SGRQ)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'classes': [{'title': 'week 12 (n=293,147)', 'categories': [{'measurements': [{'value': '32.35', 'spread': '1.232', 'groupId': 'OG000'}, {'value': '37.39', 'spread': '1.399', 'groupId': 'OG001'}]}]}, {'title': 'week 26 (n=288,144)', 'categories': [{'measurements': [{'value': '31.02', 'spread': '1.480', 'groupId': 'OG000'}, {'value': '35.94', 'spread': '1.641', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12, week 26', 'description': 'SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity and impacts. The lowest possible score is zero and the highest possible score is 100. Higher scores correspond to greater impairment in quality of life. The health-related quality of life was measured using SGRQ. It was completed by the participant at the investigators site.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '305'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '305'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'FAS, Serial Spirometry Subgroup', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': "Patient's inability to use the device", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Abnormal laboratory value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants were randomized in a 2: 1 ration to NVA237 and Placebo, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '7.84', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '8.29', 'groupId': 'BG001'}, {'value': '64.7', 'spread': '7.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-16', 'studyFirstSubmitDate': '2012-03-27', 'resultsFirstSubmitDate': '2014-06-03', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-16', 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': '12 weeks', 'description': 'Baseline FEV1 was defined as the average of the -45 min and -15 min FEV1 values taken on day 1 prior to the first dose of study medication. Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. FEV1 was measured using central spirometry according to ATS/ERS standardization. Trough FEV1 was analyzed using a MIXED model for the full analysis set population. The model contained treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation of short acting bronchodilator, FEV1 45 min post inhalation of short acting bronchodilator and baseline inhaled corticosteroids (ICS) use as covariates.'}], 'secondaryOutcomes': [{'measure': 'Transition Dyspnea Index (TDI) Score', 'timeFrame': 'Baseline, week 12, week 26', 'description': 'Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during the treatment period using the TDI, which captures changes from baseline. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort, and each domain scored from -3 (major deterioration) to +3 (major improvement), giving an overall score of -9 to +9. A negative score indicates deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.'}, {'measure': 'Change From Baseline in Daily Rescue Medication Use (Number of Puffs)', 'timeFrame': 'Baseline, 26 weeks', 'description': 'The participant recorded the rescue medication taken in an electronic diary between visits and in the spirometry device during study visits. Daytime and nighttime rescue medication use (number of puffs) over 26 weeks was analyzed.'}, {'measure': '24h Trough FEV1', 'timeFrame': 'Day 1, Week 26', 'description': 'Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. This was measured using central spirometry according to ATS/ERS standardization. This was analyzed using the same MIXED model as specified for the primary analysis.'}, {'measure': 'FEV1 and Forced Vital Capacity (FVC)', 'timeFrame': 'Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose', 'description': 'FEV1 and FVC were measured using central spirometry according to ATS/ERS standardization. Both were analyzed using the same MIXED model as specified for the primary analysis.'}, {'measure': 'Peak FEV1', 'timeFrame': 'Day 1, week 12, week 26', 'description': 'Peak FEV1 was defined as the maximum FEV1 0-4 h post-dose. Peak Fev1 was measured at 45min and 15min pre-dose and up to 4h post dose at day 1, week 12 and week 26, using central spirometry according to ATS/ERS standardization. It was analyzed using the same MIXED model as specified for the primary analysis.'}, {'measure': 'Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose', 'timeFrame': 'Day 1, week 12, week 26', 'description': 'The standardized (with respect to time) AUC for FEV1 was calculated between 5 min and 4h post morning dose at day 1, week 12 and week 26. The AUC (5 min-4 h) for FEV1 at each visit was analyzed using the same MIXED model as specified for the primary analysis.'}, {'measure': 'Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings)', 'timeFrame': 'Baseline, 26 weeks', 'description': "In an electronic diary, the participant responded to 6 questions twice daily to report on the degree of symptoms over the past 12 hours of the morning and evening. The questions covered the participant's degree of overall symptoms, and degrees of individual symptoms of coughing, wheezing, amount of sputum, color of sputum and breathlessness. Each question scored from 0 to 3 where 0 represented no symptom present and 3 represented the worst degree of that symptom. A negative change in symptom score indicates improvement."}, {'measure': 'Time to First Moderate or Severe COPD Exacerbation', 'timeFrame': '26 weeks', 'description': 'A COPD exacerbation was defined as a worsening of the following two or more major symptoms for at least 2 consecutive days:1) dyspnea; 2) sputum volume; 3) sputum purulence; or defined as a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: 1) sore throat; 2) colds (nasal discharge and/or nasal congestion); 3) fever without other cause; 4) cough; 5) wheeze. COPD exacerbations were recorded in the patient diary and other source documents.'}, {'measure': 'Number of Moderate and Severe COPD Exacerbations', 'timeFrame': '26 weeks', 'description': 'COPD exacerbations were recorded in the patient diary and other source documents. The rate of COPD exacerbations during the 26 week treatment period was analyzed using a generalized linear model assuming a negative binomial distribution.'}, {'measure': "The Total Score of the St George's Respiratory Questionnaire (SGRQ)", 'timeFrame': 'Week 12, week 26', 'description': 'SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity and impacts. The lowest possible score is zero and the highest possible score is 100. Higher scores correspond to greater impairment in quality of life. The health-related quality of life was measured using SGRQ. It was completed by the participant at the investigators site.'}]}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease (COPD)', 'NVA237'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237 in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure\n* With moderate to severe stable COPD (Stage II or Stage III).\n* Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).\n* Post-bronchodilator FEV1 ≥30% and \\< 80% of the predicted normal, and post-bronchodilator FEV1/FVC \\< 0.7 at Visit 2 (Day -14) (post means: record FEV1 and FVC 45 min after administering ipratropium).\n* Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3\n\nExclusion Criteria:\n\n* With a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.\n* Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \\> 600/mm3 (at Visit 2) or onset of symptoms prior to age 40 years. Patients without asthma but who have a blood eosinophil count \\>600/mm3 at Visit 2 are excluded.\n* Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder.\n* Patients with lung lobectomy or lung volume reduction or lung transplantation.\n* Patients with known history and diagnosis of α-1 antitrypsin deficiency.\n* Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to Visit 1 Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01566604', 'acronym': 'GLOW7', 'briefTitle': 'Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 26-week Treatment, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 (50 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'CNVA237A2309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NVA237', 'description': 'NVA237 50 µg once daily delivered via a single dose dry powder inhaler', 'interventionNames': ['Drug: NVA237']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily delivered via a single dose dry powder inhaler', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NVA237', 'type': 'DRUG', 'description': 'Delivered via a single dose dry powder inhaler', 'armGroupLabels': ['NVA237']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Delivered via a single dose dry powder inhaler', 'armGroupLabels': 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