Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00792805
Status:
COMPLETED
Last Update Posted:
2011-08-17
First Post:
2008-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Indacaterol in Adults (40 Years and Above) 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': 'Baseline to the end of the study (Week 26)', 'description': 'Safety population: All patients who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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': 187, 'otherNumAffected': 38, 'seriousNumAtRisk': 187, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Indacaterol 300 μg', 'description': 'Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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': 188, 'otherNumAffected': 50, 'seriousNumAtRisk': 188, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Placebo to Indacaterol', 'description': 'Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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': 186, 'otherNumAffected': 47, 'seriousNumAtRisk': 186, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 186, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 to Indacaterol', 'description': 'Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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': '1.29', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '0.024', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol 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. Last observation carried forward (LOCF) was utilized to impute missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 to Indacaterol', 'description': 'Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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': '188'}, {'groupId': 'FG001', 'numSubjects': '188'}, {'groupId': 'FG002', 'numSubjects': '187'}]}, {'type': 'Exposed to Study Medication or Placebo', 'achievements': [{'comment': 'One patient in this group did not receive any study treatment.', 'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '188'}, {'comment': 'One patient in this group did not receive any study treatment.', 'groupId': 'FG002', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}, {'value': '561', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Indacaterol 150 μg', 'description': 'Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 to Indacaterol', 'description': 'Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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': '66.2', 'spread': '8.01', 'groupId': 'BG000'}, {'value': '65.5', 'spread': '8.86', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '9.30', 'groupId': 'BG002'}, {'value': '65.4', 'spread': '8.75', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}, {'value': '529', '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': 563}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2008-11-17', 'resultsFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2008-11-17', 'lastUpdatePostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-22', 'studyFirstPostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85', 'timeFrame': '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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.'}]}, 'conditionsModule': {'keywords': ['COPD', 'indacaterol', 'long-acting β2-agonist', 'adults'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '24383720', 'type': 'DERIVED', 'citation': 'Yao W, Wang C, Zhong N, Han X, Wu C, Yan X, Chen P, Yang W, Henley M, Kramer B. Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: a 26-week Asia-Pacific study. Respirology. 2014 Feb;19(2):231-238. doi: 10.1111/resp.12211. Epub 2014 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged ≥ 40 years\n* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:\n\n 1. Smoking history of at least 10 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 received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period\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 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': 'NCT00792805', 'briefTitle': 'Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, 26-week 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': 'CQAB149B2333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indacaterol 150 μg', 'description': 'Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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']}, {'type': 'EXPERIMENTAL', 'label': 'Indacaterol 300 μg', 'description': 'Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to indacaterol', 'description': 'Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 to indacaterol']}], 'interventions': [{'name': 'Indacaterol 150 µg', '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', 'type': 'DRUG', 'description': 'Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).', 'armGroupLabels': ['Indacaterol 300 μg']}, {'name': 'Placebo to indacaterol', 'type': 'DRUG', 'description': 'Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).', 'armGroupLabels': ['Placebo to indacaterol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adelaide', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Clayton', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Daw Park', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.98975, 'lon': 138.58407}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'country': 'China', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shandong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.28464, 'lon': 120.48412}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shijiazhuang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': "Xi'an", 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Trivandrum', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}