Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-31 @ 3:16 PM
Study NCT ID:
NCT00622635
Status:
COMPLETED
Last Update Posted:
2011-08-18
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510790', 'term': 'indacaterol'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862 778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'otherNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'otherNumAtRisk': 66, 'otherNumAffected': 4, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '1.37', 'spread': '0.027', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After 14 days', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.44', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.022', 'groupId': 'OG001'}, {'value': '1.36', 'spread': '0.022', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '5 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '1.41', 'spread': '0.024', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '15 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '1.42', 'spread': '0.024', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '30 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '1.42', 'spread': '0.023', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 hour post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '0.025', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.51', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '1.45', 'spread': '0.024', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '0.023', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '1.45', 'spread': '0.026', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '5 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.48', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '1.42', 'spread': '0.025', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.44', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '0.026', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '1.36', 'spread': '0.025', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '1.35', 'spread': '0.027', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '11 hours 10 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '1.35', 'spread': '0.027', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '11 hours 45 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '1.39', 'spread': '0.026', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.36', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '1.31', 'spread': '0.027', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '20 hours 10 minutes post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.40', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '1.35', 'spread': '0.026', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '20 hours 45 minutes post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '1.38', 'spread': '0.026', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '22 hours post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.48', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.030', 'groupId': 'OG001'}, {'value': '1.37', 'spread': '0.031', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '23 hours 10 minutes post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Placebo to Indacaterol', 'description': 'Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Salmeterol 50 μg', 'description': 'Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '1.38', 'spread': '0.026', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '23 hours 45 minutes post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg', 'description': 'In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'FG001', 'title': 'Placebo to Indacaterol - Salmeterol 50 μg - Indacaterol 300 μg', 'description': 'In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'FG002', 'title': 'Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol', 'description': 'In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'FG003', 'title': 'Placebo to Indacaterol - Indacaterol 300 μg - Salmeterol 50 μg', 'description': 'In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'FG004', 'title': 'Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol', 'description': 'In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}, {'id': 'FG005', 'title': 'Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg', 'description': 'In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', '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': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', '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': '68', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'The entire study population included all 6 treatment groups who received indacaterol 300 µg once daily, placebo to indacaterol once daily, and salmeterol 50 µg twice daily via a single-dose (indacaterol and placebo to indacaterol) or multi-dose (salmeterol) dry-powder inhaler in 6 different sequences. Patients received each treatment for 14 days with a 14 day washout between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '9.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2008-02-04', 'resultsFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2008-02-22', 'lastUpdatePostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-22', 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)', 'timeFrame': 'After 14 days', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}], 'secondaryOutcomes': [{'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '5 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '15 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '30 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '1 hour post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '2 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '3 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '4 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '5 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '6 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '8 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '10 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '11 hours 10 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '11 hours 45 minutes post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)', 'timeFrame': '14 hours post-dose at the end of each treatment period (Day 14)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)', 'timeFrame': '20 hours 10 minutes post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)', 'timeFrame': '20 hours 45 minutes post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)', 'timeFrame': '22 hours post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)', 'timeFrame': '23 hours 10 minutes post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)', 'timeFrame': '23 hours 45 minutes post-dose at the end of each treatment period (Day 15)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.'}]}, 'conditionsModule': {'keywords': ['chronic obstructive pulmonary disease', 'COPD', 'indacaterol'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2006) and:\n\n 1. Smoking history of at least 20 pack-years\n 2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \\< 80% and ≥ 30% of the predicted normal value\n 3. Post-bronchodilator FEV1/FVC (forced vital capacity) \\< 70%\n\nExclusion Criteria:\n\n* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period\n* Patients requiring long-term oxygen therapy (\\> 15 hours a day) for chronic hypoxemia\n* Patients who have had a respiratory tract infection within 6 weeks prior to screening\n* Patients with concomitant pulmonary disease\n* Patients with a history of asthma\n* Patients with diabetes Type I or uncontrolled diabetes Type II\n* Any patient with lung cancer or a history of lung cancer\n* Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time\n* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged\n* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period\n* Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements\n\nOther protocol-defined inclusion/exclusion criteria applied to the study."}, 'identificationModule': {'nctId': 'NCT00622635', 'briefTitle': 'A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, 3-period, 14-day Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol (300 µg Once Daily [od]) in Patients With Moderate-to-severe COPD, Using Open-label Salmeterol (50 µg Twice Daily [Bis in Die, Bid]) as Active Control', 'orgStudyIdInfo': {'id': 'CQAB149B2340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indacaterol 300 μg - placebo to indacaterol - salmeterol 50 μg', 'description': 'In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol 300 μg', 'Drug: Placebo to indacaterol', 'Drug: Salmeterol 50 μg']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo to indacaterol - salmeterol 50 μg - indacaterol 300 μg', 'description': 'In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol 300 μg', 'Drug: Placebo to indacaterol', 'Drug: Salmeterol 50 μg']}, {'type': 'EXPERIMENTAL', 'label': 'Salmeterol 50 μg - indacaterol 300 μg - placebo to indacaterol', 'description': 'In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol 300 μg', 'Drug: Placebo to indacaterol', 'Drug: Salmeterol 50 μg']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo to indacaterol - indacaterol 300 μg - salmeterol 50 μg', 'description': 'In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol 300 μg', 'Drug: Placebo to indacaterol', 'Drug: Salmeterol 50 μg']}, {'type': 'EXPERIMENTAL', 'label': 'Indacaterol 300 μg - salmeterol 50 μg - placebo to indacaterol', 'description': 'In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol 300 μg', 'Drug: Placebo to indacaterol', 'Drug: Salmeterol 50 μg']}, {'type': 'EXPERIMENTAL', 'label': 'Salmeterol 50 μg - placebo to indacaterol - indacaterol 300 μg', 'description': 'In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol 300 μg', 'Drug: Placebo to indacaterol', 'Drug: Salmeterol 50 μg']}], 'interventions': [{'name': 'Indacaterol 300 μg', 'type': 'DRUG', 'description': 'Indacaterol 300 μg was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).', 'armGroupLabels': ['Indacaterol 300 μg - placebo to indacaterol - salmeterol 50 μg', 'Indacaterol 300 μg - salmeterol 50 μg - placebo to indacaterol', 'Placebo to indacaterol - indacaterol 300 μg - salmeterol 50 μg', 'Placebo to indacaterol - salmeterol 50 μg - indacaterol 300 μg', 'Salmeterol 50 μg - indacaterol 300 μg - placebo to indacaterol', 'Salmeterol 50 μg - placebo to indacaterol - indacaterol 300 μg']}, {'name': 'Placebo to indacaterol', 'type': 'DRUG', 'description': 'Placebo to indacaterol was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).', 'armGroupLabels': ['Indacaterol 300 μg - placebo to indacaterol - salmeterol 50 μg', 'Indacaterol 300 μg - salmeterol 50 μg - placebo to indacaterol', 'Placebo to indacaterol - indacaterol 300 μg - salmeterol 50 μg', 'Placebo to indacaterol - salmeterol 50 μg - indacaterol 300 μg', 'Salmeterol 50 μg - indacaterol 300 μg - placebo to indacaterol', 'Salmeterol 50 μg - placebo to indacaterol - indacaterol 300 μg']}, {'name': 'Salmeterol 50 μg', 'type': 'DRUG', 'description': 'Salmeterol 50 μg was provided in powder filled capsules with a multi-dose dry-powder inhaler (MDDPI).', 'armGroupLabels': ['Indacaterol 300 μg - placebo to indacaterol - salmeterol 50 μg', 'Indacaterol 300 μg - salmeterol 50 μg - placebo to indacaterol', 'Placebo to indacaterol - indacaterol 300 μg - salmeterol 50 μg', 'Placebo to indacaterol - salmeterol 50 μg - indacaterol 300 μg', 'Salmeterol 50 μg - indacaterol 300 μg - placebo to indacaterol', 'Salmeterol 50 μg - placebo to indacaterol - indacaterol 300 μg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'city': 'Shawnee Mission', 'state': 'Kansas', 'country': 'United States', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigator site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Herentals', 'country': 'Belgium', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.17655, 'lon': 4.83248}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Alzira', 'country': 'Spain', 'facility': 'Novartis Investigator site', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Mataró', 'country': 'Spain', 'facility': 'Novartis Investigator site', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}