Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-04 @ 3:20 PM
Study NCT ID:
NCT00794157
Status:
COMPLETED
Last Update Posted:
2011-08-17
First Post:
2008-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Confirmatory Study of Indacaterol 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': 'C510790', 'term': 'indacaterol'}]}}, '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 (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'otherNumAtRisk': 114, 'otherNumAffected': 24, 'seriousNumAtRisk': 114, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Indacaterol 300 μg', 'description': 'Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'otherNumAtRisk': 116, 'otherNumAffected': 26, 'seriousNumAtRisk': 116, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'otherNumAtRisk': 117, 'otherNumAffected': 26, 'seriousNumAtRisk': 117, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Concomitant disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 μg', 'description': 'Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.34', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '0.025', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment (Week 12 + 1 day, Day 85)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. The imputation technique used as last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 μg', 'description': 'Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.33', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '0.024', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After Week 2 (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 μg', 'description': 'Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.32', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.022', 'groupId': 'OG001'}, {'value': '1.18', 'spread': '0.024', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After Week 4 (Day 29)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 μg', 'description': 'Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '0.030', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After Week 8 (Day 57)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 μg', 'description': 'Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.34', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.030', 'groupId': 'OG001'}, {'value': '1.13', 'spread': '0.031', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Prior to last dose at Week 12 (Day 84)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'FG001', 'title': 'Indacaterol 300 μg', 'description': 'Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '347', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'BG001', 'title': 'Indacaterol 300 μg', 'description': 'Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '8.75', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '7.67', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '8.74', 'groupId': 'BG002'}, {'value': '66.7', 'spread': '8.38', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '335', 'groupId': 'BG003'}]}]}], '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': 347}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2008-11-17', 'resultsFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-22', 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)', 'timeFrame': 'End of treatment (Week 12 + 1 day, Day 85)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.'}], 'secondaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2', 'timeFrame': 'After Week 2 (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.'}, {'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4', 'timeFrame': 'After Week 4 (Day 29)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.'}, {'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8', 'timeFrame': 'After Week 8 (Day 57)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.'}, {'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)', 'timeFrame': 'Prior to last dose at Week 12 (Day 84)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.'}]}, 'conditionsModule': {'keywords': ['COPD', 'chronic obstructive pulmonary disease', 'indacaterol', 'long acting β2-agonist'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '23040786', 'type': 'DERIVED', 'citation': 'To Y, Kinoshita M, Lee SH, Hang LW, Ichinose M, Fukuchi Y, Kitawaki T, Okino N, Prasad N, Lawrence D, Kramer B. Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population. Respir Med. 2012 Dec;106(12):1715-21. doi: 10.1016/j.rmed.2012.09.002. Epub 2012 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \\[od\\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:\n\n 1. Smoking history of at least 20 pack-years.\n 2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \\< 80% and ≥ 30% of the predicted normal value.\n 3. Post-bronchodilator FEV1/FVC (forced vital capacity) \\< 70%.\n\nExclusion Criteria:\n\n* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization.\n* Patients requiring long-term oxygen therapy (\\> 15 hours a day) for chronic hypoxemia.\n* Patients who have had a respiratory tract infection within 6 weeks prior to screening.\n* Patients with concomitant pulmonary disease.\n* Patients with a history of asthma.\n* Patients with diabetes Type I or uncontrolled diabetes Type II.\n* Any patient with lung cancer or a history of lung cancer.\n* Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time.\n* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged.\n* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.\n* Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.\n\nOther protocol-defined inclusion/exclusion criteria applied to the study."}, 'identificationModule': {'nctId': 'NCT00794157', 'briefTitle': 'Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'CQAB149B1302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indacaterol 150 µg', 'description': 'Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol 150 μg capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Indacaterol 300 µg', 'description': 'Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol 300 μg capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'interventionNames': ['Drug: Placebo capsules']}], 'interventions': [{'name': 'Indacaterol 150 μg capsules', 'type': 'DRUG', 'description': 'Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).', 'armGroupLabels': ['Indacaterol 150 µg']}, {'name': 'Indacaterol 300 μg capsules', 'type': 'DRUG', 'description': 'Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).', 'armGroupLabels': ['Indacaterol 300 µg']}, {'name': 'Placebo capsules', 'type': 'DRUG', 'description': 'Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'New Territories', 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