Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT00876694
Status:
COMPLETED
Last Update Posted:
2011-11-08
First Post:
2009-04-03
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'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'Safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.', 'otherNumAtRisk': 125, 'otherNumAffected': 61, 'seriousNumAtRisk': 125, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.', 'otherNumAtRisk': 61, 'otherNumAffected': 26, 'seriousNumAtRisk': 61, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Computerised tomogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriosclerosis obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}], 'classes': [{'title': 'Low Pulse Rate:', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'High Pulse Rate:', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate \\<40 bpm or \\<= to 50 bpm and a decrease from baseline \\>= to 15 bpm. High Pulse Rate was defined as a pulse rate \\>130 bpm or \\>= to 120 bpm and an increase from baseline \\>= to 15 bpm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all patients who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}], 'classes': [{'title': 'Low Systolic Blood Pressure:', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'High Systolic Blood Pressure:', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.\n\nA Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: \\<75 mmHg or \\<= to 90 mmHg and a decrease from baseline \\>= to 20 mmHg.\n\nA High Systolic Blood Pressure was defined as a systolic blood pressure measurement: \\>200 mmHg or \\>= to 180 mmHg and an increase from baseline \\>= to 20 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all patients who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}], 'classes': [{'title': 'Low Diastolic Blood Pressure:', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'High Diastolic Blood Pressure:', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment.\n\nA Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \\<40 mmHg or \\<= to 50 mmHg and a decrease from baseline \\>= to 15 mmHg.\n\nA High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \\>115 mmHg or \\>= to 105 mmHg and an increase from baseline \\>= to 15 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all patients who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}], 'classes': [{'title': 'Notable QTc', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'QTc increase from BL: 30-60 ms', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'QTc increase from BL: >60 ms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': "The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.\n\nThe QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).\n\nNotable QTc interval \\>450 ms for males and \\>470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and \\>60 ms.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all patients who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}], 'classes': [{'title': 'Week 4 (n= 122, 57)', 'categories': [{'measurements': [{'value': '4.26', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '4.28', 'spread': '0.039', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n= 121, 56)', 'categories': [{'measurements': [{'value': '4.30', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.044', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n= 118, 56)', 'categories': [{'measurements': [{'value': '4.28', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '0.044', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n= 113, 52)', 'categories': [{'measurements': [{'value': '4.34', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.048', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (n= 106, 50)', 'categories': [{'measurements': [{'value': '4.35', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '0.044', 'groupId': 'OG001'}]}]}, {'title': 'Week 44 (n= 104, 50)', 'categories': [{'measurements': [{'value': '4.31', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.044', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n= 104, 49)', 'categories': [{'measurements': [{'value': '4.32', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '0.048', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4, 8, 12, 24, 36, 44, and 52 weeks', 'description': 'The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all patients who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}], 'classes': [{'title': 'Week 4 (n= 122, 57)', 'categories': [{'measurements': [{'value': '6.10', 'spread': '0.187', 'groupId': 'OG000'}, {'value': '5.96', 'spread': '0.260', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n= 121, 56)', 'categories': [{'measurements': [{'value': '5.92', 'spread': '0.159', 'groupId': 'OG000'}, {'value': '6.30', 'spread': '0.220', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n= 118, 56)', 'categories': [{'measurements': [{'value': '5.97', 'spread': '0.199', 'groupId': 'OG000'}, {'value': '6.59', 'spread': '0.262', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n= 113, 52)', 'categories': [{'measurements': [{'value': '6.16', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '6.13', 'spread': '0.271', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (n= 106, 50)', 'categories': [{'measurements': [{'value': '5.95', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '6.26', 'spread': '0.189', 'groupId': 'OG001'}]}]}, {'title': 'Week 44 (n= 104, 50)', 'categories': [{'measurements': [{'value': '6.09', 'spread': '0.226', 'groupId': 'OG000'}, {'value': '6.42', 'spread': '0.309', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n= 104, 49)', 'categories': [{'measurements': [{'value': '5.96', 'spread': '0.220', 'groupId': 'OG000'}, {'value': '6.65', 'spread': '0.296', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4, 8, 12, 24, 36, 44, and 52 weeks', 'description': 'The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}], 'classes': [{'title': 'Week 12 (n= 122, 56)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.019', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n= 112, 51)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.022', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n= 105, 49)', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '0.023', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After 12, 24 and 52 weeks', 'description': 'Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat (ITT) population included all randomized patients who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'FG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'BG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '7.81', 'groupId': 'BG000'}, {'value': '67.3', 'spread': '8.05', 'groupId': 'BG001'}, {'value': '69.1', 'spread': '7.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2009-04-03', 'resultsFirstSubmitDate': '2011-10-04', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-04', 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment', 'timeFrame': '52 weeks', 'description': 'The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate \\<40 bpm or \\<= to 50 bpm and a decrease from baseline \\>= to 15 bpm. High Pulse Rate was defined as a pulse rate \\>130 bpm or \\>= to 120 bpm and an increase from baseline \\>= to 15 bpm.'}, {'measure': 'The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment', 'timeFrame': '52 weeks', 'description': 'The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.\n\nA Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: \\<75 mmHg or \\<= to 90 mmHg and a decrease from baseline \\>= to 20 mmHg.\n\nA High Systolic Blood Pressure was defined as a systolic blood pressure measurement: \\>200 mmHg or \\>= to 180 mmHg and an increase from baseline \\>= to 20 mmHg.'}, {'measure': 'The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment', 'timeFrame': '52 weeks', 'description': 'The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment.\n\nA Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \\<40 mmHg or \\<= to 50 mmHg and a decrease from baseline \\>= to 15 mmHg.\n\nA High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \\>115 mmHg or \\>= to 105 mmHg and an increase from baseline \\>= to 15 mmHg.'}, {'measure': 'The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment', 'timeFrame': '52 weeks', 'description': "The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.\n\nThe QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).\n\nNotable QTc interval \\>450 ms for males and \\>470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and \\>60 ms."}, {'measure': 'Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52', 'timeFrame': '4, 8, 12, 24, 36, 44, and 52 weeks', 'description': 'The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.'}, {'measure': 'Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52', 'timeFrame': '4, 8, 12, 24, 36, 44, and 52 weeks', 'description': 'The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.'}], 'secondaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks', 'timeFrame': 'After 12, 24 and 52 weeks', 'description': 'Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates.'}]}, 'conditionsModule': {'keywords': ['COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe 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\n1\\. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:\n\n* Smoking history of at least 20 pack-years\n* Post-bronchodilator FEV1 \\<80% and ≥30% of the predicted normal value\n* Post-bronchodilator FEV1/FVC (forced vital capacity) \\<70%\n\nExclusion Criteria:\n\n1. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period\n2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1\n3. Patients with concomitant pulmonary disease\n4. Patients with a history of asthma\n5. Patients with diabetes Type I or uncontrolled diabetes Type II\n6. Any patient with lung cancer or a history of lung cancer\n7. Patients with a history of certain cardiovascular comorbid conditions\n8. Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00876694', 'briefTitle': 'Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Efficacy of Indacaterol (300 µg o.d.) Using Salmeterol (50 µg b.i.d.) as an Active Control in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'CQAB149B1303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indacaterol 300 µg', 'description': 'Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.', 'interventionNames': ['Drug: Indacaterol 300 µg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salmeterol 50 µg', 'description': 'Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.', 'interventionNames': ['Drug: Salmeterol 50 µg']}], 'interventions': [{'name': 'Indacaterol 300 µg', 'type': 'DRUG', 'description': 'Indacaterol 300 µg once daily (od) via SDDPI', 'armGroupLabels': ['Indacaterol 300 µg']}, {'name': 'Salmeterol 50 µg', 'type': 'DRUG', 'description': 'Salmeterol 50 µg twice daily (bid) via Diskus®', 'armGroupLabels': ['Salmeterol 50 µg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asahikawa', 'country': 'Japan', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Bunkyō City', 'country': 'Japan', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'city': 'Gifu', 'country': 'Japan', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Hamamatsu', 'country': 'Japan', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 34.7, 'lon': 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'geoPoint': {'lat': 34.96667, 'lon': 136.61667}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}