Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00393458
Status:
COMPLETED
Last Update Posted:
2011-08-18
First Post:
2006-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Sweden']}, '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': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, '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': 'Safety population: All patients who received at least 1 dose of study drug.', 'description': 'Baseline to the end of the study (Week 52)', 'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol 300 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 437, 'otherNumAffected': 199, 'seriousNumAtRisk': 437, 'seriousNumAffected': 63}, {'id': 'EG001', 'title': 'Indacaterol 600 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 425, 'otherNumAffected': 183, 'seriousNumAtRisk': 425, 'seriousNumAffected': 51}, {'id': 'EG002', 'title': 'Formoterol 12 μg Plus Placebo to Indacaterol', 'description': "Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 434, 'otherNumAffected': 164, 'seriousNumAtRisk': 434, 'seriousNumAffected': 69}, {'id': 'EG003', 'title': 'Placebo to Indacaterol Plus Placebo to Formoterol', 'description': "Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 432, 'otherNumAffected': 176, 'seriousNumAtRisk': 432, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 62}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 108}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 112}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 138}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Microvascular angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anterior capsule contraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femoral hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Obliterative bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhoid operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriosclerosis obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}], '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': '389', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}, {'value': '371', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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 600 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 'Formoterol 12 μg Plus Placebo to Indacaterol', 'description': "Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 'OG003', 'title': 'Placebo to Indacaterol Plus Placebo to Formoterol', 'description': "Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': '1.48', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '0.013', 'groupId': 'OG001'}, {'value': '1.38', 'spread': '0.013', 'groupId': 'OG002'}, {'value': '1.31', 'spread': '0.013', 'groupId': 'OG003'}]}]}], '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, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days of Poor Control During 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '377', 'groupId': 'OG002'}, {'value': '366', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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 600 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 'Formoterol 12 μg Plus Placebo to Indacaterol', 'description': "Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 'OG003', 'title': 'Placebo to Indacaterol Plus Placebo to Formoterol', 'description': "Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': '33.6', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '1.46', 'groupId': 'OG001'}, {'value': '33.5', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '38.3', 'spread': '1.47', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of study (Week 52)', 'description': 'Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indacaterol 300 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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 600 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 'Formoterol 12 μg Plus Placebo to Indacaterol', 'description': "Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 'FG003', 'title': 'Placebo to Indacaterol Plus Placebo to Formoterol', 'description': "Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': '437'}, {'groupId': 'FG001', 'numSubjects': '428'}, {'groupId': 'FG002', 'numSubjects': '435'}, {'groupId': 'FG003', 'numSubjects': '432'}]}, {'type': 'Exposed to Study Medication or Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '437'}, {'groupId': 'FG001', 'numSubjects': '425'}, {'groupId': 'FG002', 'numSubjects': '434'}, {'groupId': 'FG003', 'numSubjects': '432'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '338'}, {'groupId': 'FG001', 'numSubjects': '326'}, {'groupId': 'FG002', 'numSubjects': '323'}, {'groupId': 'FG003', 'numSubjects': '295'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '112'}, {'groupId': 'FG003', 'numSubjects': '137'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Subject no longer requires study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}, {'value': '432', 'groupId': 'BG003'}, {'value': '1728', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Indacaterol 300 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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 600 μg Plus Placebo to Formoterol', 'description': "Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 'Formoterol 12 μg Plus Placebo to Indacaterol', 'description': "Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 'Placebo to Indacaterol Plus Placebo to Formoterol', 'description': "Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '8.57', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '8.74', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '8.49', 'groupId': 'BG002'}, {'value': '63.2', 'spread': '8.28', 'groupId': 'BG003'}, {'value': '63.4', 'spread': '8.52', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Demographic data are based on all subjects in the safety population, which includes all patients who received at least 1 dose of study drug. Three patients in the indacaterol 600 μg plus placebo to formoterol and one patient in the formoterol 12 μg plus placebo to indacaterol group were not exposed to any study treatment.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '350', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '327', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}, {'value': '352', 'groupId': 'BG003'}, {'value': '1378', 'groupId': 'BG004'}]}]}], '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': 1732}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2006-10-25', 'resultsFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2006-10-25', 'lastUpdatePostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-22', 'studyFirstPostDateStruct': {'date': '2006-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', '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, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Days of Poor Control During 52 Weeks of Treatment', 'timeFrame': 'Baseline to end of study (Week 52)', 'description': 'Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.'}]}, 'conditionsModule': {'keywords': ['chronic obstructive pulmonary disease', 'COPD', 'indacaterol', 'long-acting β2 agonist'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '22206353', 'type': 'DERIVED', 'citation': 'Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.'}, {'pmid': '22003288', 'type': 'DERIVED', 'citation': 'Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.'}, {'pmid': '21397482', 'type': 'DERIVED', 'citation': 'Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.'}, {'pmid': '21227674', 'type': 'DERIVED', 'citation': 'Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.'}, {'pmid': '20522841', 'type': 'DERIVED', 'citation': 'Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 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 volume capacity) \\< 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)\n\n Exclusion Criteria:\n* Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.\n* Patients who 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* Patients with a history of certain cardiovascular co-morbid conditions.\n\nOther protocol-defined inclusion/exclusion criteria applied to the study.'}, 'identificationModule': {'nctId': 'NCT00393458', 'briefTitle': 'Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control', 'orgStudyIdInfo': {'id': 'CQAB149B2334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indacaterol 300 μg plus placebo to formoterol', 'description': "Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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', 'Drug: Placebo to formoterol']}, {'type': 'EXPERIMENTAL', 'label': 'Indacaterol 600 μg plus placebo to formoterol', 'description': "Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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', 'Drug: Placebo to formoterol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formoterol 12 μg plus placebo to indacaterol', 'description': "Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. 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: Formoterol', 'Drug: Placebo to indacaterol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to indacaterol plus placebo to formoterol', 'description': "Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. 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