Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT00463567
Status:
COMPLETED
Last Update Posted:
2011-08-18
First Post:
2007-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
26 Week Efficacy, Safety and Tolerability 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'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'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'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, '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': {'description': 'Safety Population including all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol 150 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'otherNumAtRisk': 416, 'otherNumAffected': 159, 'seriousNumAtRisk': 416, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Indacaterol 300 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'otherNumAtRisk': 416, 'otherNumAffected': 159, 'seriousNumAtRisk': 416, 'seriousNumAffected': 32}, {'id': 'EG002', 'title': 'Tiotropium 18 µg (Continued Into Stage 2)', 'description': "Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.", 'otherNumAtRisk': 415, 'otherNumAffected': 156, 'seriousNumAtRisk': 415, 'seriousNumAffected': 34}, {'id': 'EG003', 'title': 'Placebo (Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'otherNumAtRisk': 418, 'otherNumAffected': 155, 'seriousNumAtRisk': 418, 'seriousNumAffected': 35}, {'id': 'EG004', 'title': 'Indacaterol 75 µg (Not Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'otherNumAtRisk': 127, 'otherNumAffected': 39, 'seriousNumAtRisk': 127, 'seriousNumAffected': 9}, {'id': 'EG005', 'title': 'Indacaterol 600 µg (Not Continued Into Stage 2)', 'description': 'In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'otherNumAtRisk': 122, 'otherNumAffected': 44, 'seriousNumAtRisk': 122, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Formoterol 12 µg (Not Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'otherNumAtRisk': 122, 'otherNumAffected': 31, 'seriousNumAtRisk': 122, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 75}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 86}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endocardial fibroelastosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 1}, 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'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 416, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 416, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 122, '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) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '376', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG002', 'title': 'Tiotropium 18 µg (Continued Into Stage 2)', 'description': "Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."}, {'id': 'OG003', 'title': 'Placebo (Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '1.42', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '1.28', 'spread': '0.015', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 12 weeks of treatment', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent to Treat Population of Stage 2 of the study who received at least one dose of study drug and for whom data was available for FEV1 at 12 weeks. Imputed with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '362', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG002', 'title': 'Tiotropium (Continued Into Stage 2)', 'description': "Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."}, {'id': 'OG003', 'title': 'Placebo (Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '1.51', 'groupId': 'OG001'}, {'value': '31.0', 'spread': '1.50', 'groupId': 'OG002'}, {'value': '34.0', 'spread': '1.53', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 26 weeks', 'description': 'A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participant\'s diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of "days of poor control" as well as FEV1 reversibility components as covariates.', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population consisting of all participants in Stage 2 of the study who received at least one dose of study drug. Eligible participants for the analysis were those with ≥7 evaluable diary days in the baseline period and ≥30% evaluable diary days (at least 20 days) in total.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '104', 'groupId': 'OG004'}, {'value': '108', 'groupId': 'OG005'}, {'value': '105', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 µg', 'description': 'In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 µg', 'description': 'In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG002', 'title': 'Tiotropium 18 µg', 'description': "Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."}, {'id': 'OG003', 'title': 'Placebo', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG004', 'title': 'Indacaterol 75 µg', 'description': 'In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG005', 'title': 'Indacaterol 600 µg', 'description': 'In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG006', 'title': 'Formoterol 12 µg', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '1.45', 'spread': '0.023', 'groupId': 'OG002'}, {'value': '1.31', 'spread': '0.024', 'groupId': 'OG003'}, {'value': '1.46', 'spread': '0.024', 'groupId': 'OG004'}, {'value': '1.51', 'spread': '0.024', 'groupId': 'OG005'}, {'value': '1.42', 'spread': '0.024', 'groupId': 'OG006'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 15, After 2 Weeks of treatment in Stage 1', 'description': 'Interim Analysis: Stage 1.\n\nSpirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for Trough FEV1 at Day 15. Missing data were imputed using last observation carried forward (LOCF).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 µg', 'description': 'In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 µg', 'description': 'In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG002', 'title': 'Tiotropium 18 µg', 'description': "Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."}, {'id': 'OG003', 'title': 'Placebo', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG004', 'title': 'Indacaterol 75 µg', 'description': 'In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG005', 'title': 'Indacaterol 600 µg', 'description': 'In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'OG006', 'title': 'Formoterol 12 µg', 'description': 'In the morning, Placebo to Indacaterol delivered via SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.53', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.034', 'groupId': 'OG001'}, {'value': '1.49', 'spread': '0.034', 'groupId': 'OG002'}, {'value': '1.30', 'spread': '0.033', 'groupId': 'OG003'}, {'value': '1.50', 'spread': '0.034', 'groupId': 'OG004'}, {'value': '1.53', 'spread': '0.034', 'groupId': 'OG005'}, {'value': '1.52', 'spread': '0.035', 'groupId': 'OG006'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14, After 2 Weeks of treatment in Stage 1', 'description': 'Interim Analysis: Stage 1.\n\nSpirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for AUC 1h-4h FEV1 at Day 14. Missing data were imputed using last observation carried forward (LOCF).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indacaterol 150 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'FG001', 'title': 'Indacaterol 300 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'FG002', 'title': 'Tiotropium (Continued Into Stage 2)', 'description': "Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."}, {'id': 'FG003', 'title': 'Placebo (Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'FG004', 'title': 'Indacaterol 75 µg (Not Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'FG005', 'title': 'Indacaterol 600 µg (Not Continued Into Stage 2)', 'description': 'In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'FG006', 'title': 'Formoterol 12 µg (Not Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized Participants', 'groupId': 'FG000', 'numSubjects': '420'}, {'groupId': 'FG001', 'numSubjects': '418'}, {'groupId': 'FG002', 'numSubjects': '420'}, {'groupId': 'FG003', 'numSubjects': '425'}, {'groupId': 'FG004', 'numSubjects': '130'}, {'groupId': 'FG005', 'numSubjects': '123'}, {'groupId': 'FG006', 'numSubjects': '123'}]}, {'type': 'Safety Population: Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '416'}, {'groupId': 'FG001', 'numSubjects': '416'}, {'groupId': 'FG002', 'numSubjects': '415'}, {'groupId': 'FG003', 'numSubjects': '418'}, {'comment': "'Completed' indicates the number of patients in the interim analysis.", 'groupId': 'FG004', 'numSubjects': '127'}, {'comment': "'Completed' indicates the number of patients in the interim analysis.", 'groupId': 'FG005', 'numSubjects': '122'}, {'comment': "'Completed' indicates the number of patients in the interim analysis.", 'groupId': 'FG006', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '325'}, {'groupId': 'FG001', 'numSubjects': '341'}, {'groupId': 'FG002', 'numSubjects': '331'}, {'groupId': 'FG003', 'numSubjects': '294'}, {'groupId': 'FG004', 'numSubjects': '107'}, {'groupId': 'FG005', 'numSubjects': '102'}, {'groupId': 'FG006', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '89'}, {'groupId': 'FG003', 'numSubjects': '131'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '21'}, {'groupId': 'FG006', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Abnormal lab value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study consisted of two stages: a dose selection stage (Stage 1, 2 weeks) from which 2 out of 4 Indacaterol doses were selected following interim analysis to continue into Stage 2 for comparisons of efficacy, safety, and tolerability for total treatment of up to 26 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'BG000'}, {'value': '416', 'groupId': 'BG001'}, {'value': '415', 'groupId': 'BG002'}, {'value': '418', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}, {'value': '122', 'groupId': 'BG005'}, {'value': '122', 'groupId': 'BG006'}, {'value': '2036', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Indacaterol 150 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'BG001', 'title': 'Indacaterol 300 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'BG002', 'title': 'Tiotropium 18 µg (Continued Into Stage 2)', 'description': "Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."}, {'id': 'BG003', 'title': 'Placebo (Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'BG004', 'title': 'Indacaterol 75 µg (Not Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'BG005', 'title': 'Indacaterol 600 µg (Not Continued Into Stage 2)', 'description': 'In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'BG006', 'title': 'Formoterol 12 µg (Not Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 40 and 64 years', 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '215', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '56', 'groupId': 'BG006'}, {'value': '1048', 'groupId': 'BG007'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '66', 'groupId': 'BG006'}, {'value': '988', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'description': 'Baseline Measures were based on the Safety Population that included all participants who received at least one dose of study drug.', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '52', 'groupId': 'BG006'}, {'value': '770', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}, {'value': '74', 'groupId': 'BG005'}, {'value': '70', 'groupId': 'BG006'}, {'value': '1266', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2059}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2007-04-19', 'resultsFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2007-04-19', 'lastUpdatePostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-22', 'studyFirstPostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment', 'timeFrame': 'Day 15, After 2 Weeks of treatment in Stage 1', 'description': 'Interim Analysis: Stage 1.\n\nSpirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment', 'timeFrame': 'Day 14, After 2 Weeks of treatment in Stage 1', 'description': 'Interim Analysis: Stage 1.\n\nSpirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.'}], 'primaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment', 'timeFrame': 'after 12 weeks of treatment', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.'}], 'secondaryOutcomes': [{'measure': 'The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period', 'timeFrame': 'up to 26 weeks', 'description': 'A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participant\'s diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of "days of poor control" as well as FEV1 reversibility components as covariates.'}]}, 'conditionsModule': {'keywords': ['indacaterol', 'long acting beta-2 agonist'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'COPD', 'Lung Diseases, Obstructive']}, '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': '22158330', 'type': 'DERIVED', 'citation': 'Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.'}, {'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': '20463178', 'type': 'DERIVED', 'citation': 'Donohue JF, Fogarty C, Lotvall J, Mahler DA, Worth H, Yorgancioglu A, Iqbal A, Swales J, Owen R, Higgins M, Kramer B; INHANCE Study Investigators. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010 Jul 15;182(2):155-62. doi: 10.1164/rccm.200910-1500OC. Epub 2010 May 12.'}]}, 'descriptionModule': {'briefSummary': 'Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \\& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure\n* Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) 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 \\< 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period\n* Patients requiring long term oxygen therapy (\\> 15 h a day)\n* Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)\n* Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis\n* Patients with a history of asthma (with further criteria)\n* Patients with Type I or uncontrolled Type II diabetes\n* Patients with contraindications for tiotropium\n* Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality\n* Any patient with active cancer or a history of cancer with less than 5 years disease free survival time\n* Patients with a history of long QT syndrome or whose QTc interval is prolonged\n* Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures\n* Patients who have had treatment with the investigational drug (with further criteria)\n* Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period\n* Patients with known history of non compliance to medication\n* Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00463567', 'briefTitle': '26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls', 'orgStudyIdInfo': {'id': 'CQAB149B2335S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indacaterol 150 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'interventionNames': ['Drug: Indacaterol', 'Drug: Placebo to Indacaterol', 'Drug: Placebo to Formoterol']}, {'type': 'EXPERIMENTAL', 'label': 'Indacaterol 300 µg (Continued Into Stage 2)', 'description': 'In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'interventionNames': ['Drug: Indacaterol', 'Drug: Placebo to Indacaterol', 'Drug: Placebo to Formoterol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tiotropium 18 µg (Continued Into Stage 2)', 'description': "Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.", 'interventionNames': ['Drug: Tiotropium (18 µg o.d.)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'interventionNames': ['Drug: Placebo to Indacaterol', 'Drug: Placebo to Formoterol']}, {'type': 'EXPERIMENTAL', 'label': 'Indacaterol 75 µg (Not Continued into Stage 2)', 'description': 'In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'interventionNames': ['Drug: Indacaterol', 'Drug: Placebo to Indacaterol', 'Drug: Placebo to Formoterol']}, {'type': 'EXPERIMENTAL', 'label': 'Indacaterol 600 µg (Not Continued Into Stage 2)', 'description': 'In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.\n\nDaily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.', 'interventionNames': ['Drug: Indacaterol', 'Drug: Placebo to Formoterol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formoterol 12 µg (Not Continued Into Stage 2)', 'description': 'In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. 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