Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT00557466
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2007-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510790', 'term': 'indacaterol'}, {'id': '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 (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.', 'otherNumAtRisk': 98, 'otherNumAffected': 4, 'seriousNumAtRisk': 98, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.', 'otherNumAtRisk': 92, 'otherNumAffected': 5, 'seriousNumAtRisk': 92, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.', 'otherNumAtRisk': 101, 'otherNumAffected': 3, 'seriousNumAtRisk': 101, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.', 'otherNumAtRisk': 96, 'otherNumAffected': 4, 'seriousNumAtRisk': 96, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.', 'otherNumAtRisk': 90, 'otherNumAffected': 6, 'seriousNumAtRisk': 90, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.', 'otherNumAtRisk': 91, 'otherNumAffected': 8, 'seriousNumAtRisk': 91, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 91, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 91, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONFUSIONAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.051', 'spread': '0.0207', 'groupId': 'OG000'}, {'value': '0.073', 'spread': '0.0217', 'groupId': 'OG001'}, {'value': '0.076', 'spread': '0.0210', 'groupId': 'OG002'}, {'value': '0.121', 'spread': '0.0211', 'groupId': 'OG003'}, {'value': '0.098', 'spread': '0.0219', 'groupId': 'OG004'}, {'value': '0.005', 'spread': '0.0223', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (prior to first dose) and Day 15 (24 hours after last dose)', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.'}, {'type': 'SECONDARY', 'title': 'Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}, {'value': '81', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.407', 'spread': '0.0193', 'groupId': 'OG000'}, {'value': '1.461', 'spread': '0.0202', 'groupId': 'OG001'}, {'value': '1.441', 'spread': '0.0196', 'groupId': 'OG002'}, {'value': '1.500', 'spread': '0.0198', 'groupId': 'OG003'}, {'value': '1.541', 'spread': '0.0206', 'groupId': 'OG004'}, {'value': '1.315', 'spread': '0.0208', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.', 'description': 'FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.'}, {'type': 'SECONDARY', 'title': 'The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.028', 'spread': '0.0152', 'groupId': 'OG000'}, {'value': '0.054', 'spread': '0.0158', 'groupId': 'OG001'}, {'value': '0.060', 'spread': '0.0151', 'groupId': 'OG002'}, {'value': '0.073', 'spread': '0.0156', 'groupId': 'OG003'}, {'value': '0.140', 'spread': '0.0160', 'groupId': 'OG004'}, {'value': '-0.009', 'spread': '0.0160', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 Baseline (prior to first dose) and 24 hours post-dose.', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.'}, {'type': 'SECONDARY', 'title': 'Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.371', 'spread': '0.0111', 'groupId': 'OG000'}, {'value': '1.422', 'spread': '0.0116', 'groupId': 'OG001'}, {'value': '1.427', 'spread': '0.0112', 'groupId': 'OG002'}, {'value': '1.438', 'spread': '0.0116', 'groupId': 'OG003'}, {'value': '1.535', 'spread': '0.0118', 'groupId': 'OG004'}, {'value': '1.321', 'spread': '0.0118', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.', 'description': 'FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.'}, {'type': 'SECONDARY', 'title': 'Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '89', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}], 'classes': [{'title': 'Day 1 [N=98, 91, 97, 91, 87, 87]', 'categories': [{'measurements': [{'value': '80.9', 'spread': '76.01', 'groupId': 'OG000'}, {'value': '84.4', 'spread': '77.74', 'groupId': 'OG001'}, {'value': '101.4', 'spread': '83.44', 'groupId': 'OG002'}, {'value': '105.3', 'spread': '81.85', 'groupId': 'OG003'}, {'value': '115.0', 'spread': '81.59', 'groupId': 'OG004'}, {'value': '85.7', 'spread': '81.44', 'groupId': 'OG005'}]}]}, {'title': 'Day 14 [N=93, 86, 90, 89, 83, 82]', 'categories': [{'measurements': [{'value': '91.3', 'spread': '81.20', 'groupId': 'OG000'}, {'value': '105.6', 'spread': '82.53', 'groupId': 'OG001'}, {'value': '104.7', 'spread': '75.96', 'groupId': 'OG002'}, {'value': '116.4', 'spread': '85.03', 'groupId': 'OG003'}, {'value': '89.1', 'spread': '72.91', 'groupId': 'OG004'}, {'value': '68.0', 'spread': '70.38', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by "N".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Morning and Evening Peak Expiratory Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '89', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}], 'classes': [{'title': 'Morning [N=56, 63, 59, 54, 54, 55]', 'categories': [{'measurements': [{'value': '3.10', 'spread': '29.709', 'groupId': 'OG000'}, {'value': '19.91', 'spread': '34.060', 'groupId': 'OG001'}, {'value': '23.63', 'spread': '30.707', 'groupId': 'OG002'}, {'value': '11.11', 'spread': '36.787', 'groupId': 'OG003'}, {'value': '16.06', 'spread': '31.544', 'groupId': 'OG004'}, {'value': '-4.24', 'spread': '31.357', 'groupId': 'OG005'}]}]}, {'title': 'Evening [N=56, 58, 56, 49, 48, 52]', 'categories': [{'measurements': [{'value': '-2.72', 'spread': '28.816', 'groupId': 'OG000'}, {'value': '13.42', 'spread': '30.500', 'groupId': 'OG001'}, {'value': '19.00', 'spread': '24.004', 'groupId': 'OG002'}, {'value': '5.92', 'spread': '43.490', 'groupId': 'OG003'}, {'value': '14.97', 'spread': '40.355', 'groupId': 'OG004'}, {'value': '-2.75', 'spread': '35.034', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (recorded during the screening period) and Days 1-14 (treatment period).', 'description': 'The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.', 'unitOfMeasure': 'liters/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population. The analysis only includes patients with non-missing data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '89', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'OG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}], 'classes': [{'title': 'Day', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '70', 'groupId': 'OG005'}]}]}, {'title': 'Night', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}, {'value': '72', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Over 14 days', 'description': 'Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'FG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'FG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'FG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'FG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.'}, {'id': 'FG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '101'}, {'groupId': 'FG003', 'numSubjects': '96'}, {'groupId': 'FG004', 'numSubjects': '90'}, {'groupId': 'FG005', 'numSubjects': '91'}]}, {'type': 'Safety Population', 'achievements': [{'comment': 'All randomized patients who received at least one dose of the study drug', 'groupId': 'FG000', 'numSubjects': '98'}, {'comment': 'All randomized patients who received at least one dose of the study drug', 'groupId': 'FG001', 'numSubjects': '92'}, {'comment': 'All randomized patients who received at least one dose of the study drug', 'groupId': 'FG002', 'numSubjects': '101'}, {'comment': 'All randomized patients who received at least one dose of the study drug', 'groupId': 'FG003', 'numSubjects': '96'}, {'comment': 'All randomized patients who received at least one dose of the study drug', 'groupId': 'FG004', 'numSubjects': '90'}, {'comment': 'All randomized patients who received at least one dose of the study drug', 'groupId': 'FG005', 'numSubjects': '91'}]}, {'type': 'Intent to Treat Population', 'achievements': [{'comment': 'All randomized patients who had a baseline and at least one post-dose FEV1 measurement', 'groupId': 'FG000', 'numSubjects': '98'}, {'comment': 'All randomized patients who had a baseline and at least one post-dose FEV1 measurement', 'groupId': 'FG001', 'numSubjects': '91'}, {'comment': 'All randomized patients who had a baseline and at least one post-dose FEV1 measurement', 'groupId': 'FG002', 'numSubjects': '98'}, {'comment': 'All randomized patients who had a baseline and at least one post-dose FEV1 measurement', 'groupId': 'FG003', 'numSubjects': '93'}, {'comment': 'All randomized patients who had a baseline and at least one post-dose FEV1 measurement', 'groupId': 'FG004', 'numSubjects': '87'}, {'comment': 'All randomized patients who had a baseline and at least one post-dose FEV1 measurement', 'groupId': 'FG005', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '92'}, {'groupId': 'FG004', 'numSubjects': '87'}, {'groupId': 'FG005', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Abnormal test procedure results', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}, {'value': '89', 'groupId': 'BG005'}, {'value': '556', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'BG001', 'title': 'Indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'BG002', 'title': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'BG003', 'title': 'Indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'BG004', 'title': 'Formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.'}, {'id': 'BG005', 'title': 'Placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'spread': '7.69', 'groupId': 'BG000'}, {'value': '61.6', 'spread': '9.51', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '8.68', 'groupId': 'BG002'}, {'value': '61.9', 'spread': '8.48', 'groupId': 'BG003'}, {'value': '63.3', 'spread': '8.36', 'groupId': 'BG004'}, {'value': '62.2', 'spread': '8.84', 'groupId': 'BG005'}, {'value': '62.1', 'spread': '8.58', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Total number of baseline participants is based on the Intent to Treat Population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '157', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}, {'value': '399', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 568}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-12', 'studyFirstSubmitDate': '2007-11-13', 'resultsFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2007-11-13', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-12', 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline (prior to first dose) and Day 15 (24 hours after last dose)', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.'}], 'secondaryOutcomes': [{'measure': 'Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose', 'timeFrame': 'Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.', 'description': 'FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.'}, {'measure': 'The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1', 'timeFrame': 'Day 1 Baseline (prior to first dose) and 24 hours post-dose.', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.'}, {'measure': 'Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1', 'timeFrame': 'Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.', 'description': 'FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.'}, {'measure': 'Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14', 'timeFrame': 'Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.'}, {'measure': 'Change From Baseline in Morning and Evening Peak Expiratory Flow', 'timeFrame': 'Baseline (recorded during the screening period) and Days 1-14 (treatment period).', 'description': 'The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.'}, {'measure': 'Number of Participants Using Rescue Medication', 'timeFrame': 'Over 14 days', 'description': 'Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.'}]}, 'conditionsModule': {'keywords': ['QMF', 'indacaterol', 'TWISTHALER® device'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.'}, '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 (which include any adjustment to their current COPD treatment)\n* Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:\n\n * Smoking history of at least 10 pack years\n * Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \\< 80% and ≥30% of the predicted normal value.\n * Post-bronchodilator FEV1/Forced vital capacity (FVC) \\< 70%\n\nExclusion Criteria:\n\n* Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.\n* Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.\n* Patients with a history of asthma.\n* Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.\n* Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00557466', 'briefTitle': 'A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Patients With COPD', 'orgStudyIdInfo': {'id': 'CQMF149B2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'indacaterol 62.5 μg', 'description': 'Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.', 'interventionNames': ['Drug: indacaterol', 'Drug: placebo to formoterol', 'Drug: short acting β2- agonist']}, {'type': 'EXPERIMENTAL', 'label': 'indacaterol 125 μg', 'description': 'Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.', 'interventionNames': ['Drug: indacaterol', 'Drug: placebo to formoterol', 'Drug: short acting β2- agonist']}, {'type': 'EXPERIMENTAL', 'label': 'Indacaterol 250 μg', 'description': 'Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.', 'interventionNames': ['Drug: indacaterol', 'Drug: placebo to formoterol', 'Drug: short acting β2- agonist']}, {'type': 'EXPERIMENTAL', 'label': 'indacaterol 500 μg', 'description': 'Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.', 'interventionNames': ['Drug: indacaterol', 'Drug: placebo to formoterol', 'Drug: short acting β2- agonist']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'formoterol', 'description': 'Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.', 'interventionNames': ['Drug: formoterol', 'Drug: placebo to indacaterol', 'Drug: short acting β2- agonist']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.', 'interventionNames': ['Drug: placebo to indacaterol', 'Drug: placebo to formoterol', 'Drug: short acting β2- agonist']}], 'interventions': [{'name': 'indacaterol', 'type': 'DRUG', 'description': 'Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).', 'armGroupLabels': ['Indacaterol 250 μg', 'indacaterol 125 μg', 'indacaterol 500 μg', 'indacaterol 62.5 μg']}, {'name': 'formoterol', 'type': 'DRUG', 'description': 'Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.', 'armGroupLabels': ['formoterol']}, {'name': 'placebo to indacaterol', 'type': 'DRUG', 'description': 'Placebo TWISTHALER® device', 'armGroupLabels': ['formoterol', 'placebo']}, {'name': 'placebo to formoterol', 'type': 'DRUG', 'description': 'Placebo AEROLIZER® device', 'armGroupLabels': ['Indacaterol 250 μg', 'indacaterol 125 μg', 'indacaterol 500 μg', 'indacaterol 62.5 μg', 'placebo']}, {'name': 'short acting β2- agonist', 'type': 'DRUG', 'description': '100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).', 'armGroupLabels': ['Indacaterol 250 μg', 'formoterol', 'indacaterol 125 μg', 'indacaterol 500 μg', 'indacaterol 62.5 μg', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigator site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Rosario', 'country': 'Argentina', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Santillán', 'country': 'Argentina', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -29.46546, 'lon': -58.97963}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Val Pariso', 'country': 'Chile', 'facility': 'Novartis Investigator Site'}, {'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'city': 'Clermot Ferand', 'country': 'France', 'facility': 'Novartis Investigator Site'}, {'city': 'Lille', 'country': 'France', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Novartis Investigator site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bibertal', 'country': 'Germany', 'facility': 'Novartis Investigator site'}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Novartis Investigator Site - 2 sites', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Koblenz', 'country': 'Germany', 'facility': 'novartis Investigator site', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Solingen', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.17343, 'lon': 7.0845}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Pécs', 'country': 'Hungary', 'facility': 'Novartis investigator site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Novartis investigator site', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Pordenone', 'country': 'Italy', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 45.95689, 'lon': 12.66051}}, {'city': 'Daugavpils', 'country': 'Latvia', 'facility': 'Novartis investigator site', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Klaipėda', 'country': 'Lithuania', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Tronheim', 'country': 'Norway', 'facility': 'Novartis Investigator Site'}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Izabelin', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.29992, 'lon': 20.81729}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Mrozy', 'country': 'Poland', 'facility': 'Novartis Investigator site', 'geoPoint': {'lat': 52.16609, 'lon': 21.80263}}, {'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'city': 'Wejhrowo', 'country': 'Poland', 'facility': 'Novartis Investigator Site'}, {'city': 'Włocławek', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.64817, 'lon': 19.0678}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Bloemfontain', 'country': 'South Africa', 'facility': 'Novartis Investigator Site'}, {'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Durban', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'eManzimtoti', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -30.05219, 'lon': 30.88527}}, {'city': 'George', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Tygerberg', 'country': 'South Africa', 'facility': 'Novartis Investigator Site'}, {'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}, {'city': 'Isparta', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 37.76444, 'lon': 30.55222}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Kahramanmaraş', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}, {'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}, {'city': 'Manisa', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 38.61202, 'lon': 27.42647}}, {'city': 'Sanliurfa', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}, {'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}, {'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'city': 'Chesterfield', 'country': 'United Kingdom', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 53.25, 'lon': -1.41667}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Warminster', 'country': 'United Kingdom', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.20434, 'lon': -2.17873}}, {'city': 'Watford', 'country': 'United Kingdom', 'facility': 'Novartis investigator site', 'geoPoint': {'lat': 51.65531, 'lon': -0.39602}}, {'city': 'Whitstable', 'country': 'United Kingdom', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.3607, 'lon': 1.0257}}], 'overallOfficials': [{'name': 'Novartis Pharma AG', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Schering-Plough', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}