Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-29 @ 10:04 PM
Study NCT ID:
NCT01040403
Status:
COMPLETED
Last Update Posted:
2015-07-15
First Post:
2009-12-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in 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': 'C549647', 'term': 'olodaterol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 21 days after the last administration, up to 75 days', 'eventGroups': [{'id': 'EG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.', 'otherNumAtRisk': 108, 'otherNumAffected': 15, 'seriousNumAtRisk': 108, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.', 'otherNumAtRisk': 109, 'otherNumAffected': 15, 'seriousNumAtRisk': 109, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.', 'otherNumAtRisk': 113, 'otherNumAffected': 11, 'seriousNumAtRisk': 113, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.', 'otherNumAtRisk': 109, 'otherNumAffected': 11, 'seriousNumAtRisk': 109, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.', 'otherNumAtRisk': 109, 'otherNumAffected': 12, 'seriousNumAtRisk': 109, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.', 'otherNumAtRisk': 110, 'otherNumAffected': 13, 'seriousNumAtRisk': 110, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.', 'otherNumAtRisk': 110, 'otherNumAffected': 7, 'seriousNumAtRisk': 110, 'seriousNumAffected': 5}, {'id': 'EG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.', 'otherNumAtRisk': 111, 'otherNumAffected': 6, 'seriousNumAtRisk': 111, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 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109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trough FEV1 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.071', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.125', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.136', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '0.155', 'spread': '0.018', 'groupId': 'OG003'}, {'value': '0.083', 'spread': '0.018', 'groupId': 'OG004'}, {'value': '0.134', 'spread': '0.018', 'groupId': 'OG005'}, {'value': '0.166', 'spread': '0.018', 'groupId': 'OG006'}, {'value': '0.163', 'spread': '0.018', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.054', 'ciLowerLimit': '0.016', 'ciUpperLimit': '0.092', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.065', 'ciLowerLimit': '0.027', 'ciUpperLimit': '0.103', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean 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'ciPctValue': '95', 'paramValue': '0.030', 'ciLowerLimit': '-0.008', 'ciUpperLimit': '0.069', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.019', 'ciLowerLimit': '-0.019', 'ciUpperLimit': '0.058', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.051', 'ciLowerLimit': '0.013', 'ciUpperLimit': '0.089', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.083', 'ciLowerLimit': '0.045', 'ciUpperLimit': '0.122', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.080', 'ciLowerLimit': '0.042', 'ciUpperLimit': '0.119', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.033', 'ciLowerLimit': '-0.006', 'ciUpperLimit': '0.071', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.030', 'ciLowerLimit': '-0.009', 'ciUpperLimit': '0.068', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.003', 'ciLowerLimit': '-0.041', 'ciUpperLimit': '0.035', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29', 'description': 'Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) which comprised all patients in the treated set who provided baseline (study baseline) data and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.'}, {'type': 'SECONDARY', 'title': 'Trough Forced Vital Capacity (FVC) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.114', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.214', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.234', 'spread': '0.029', 'groupId': 'OG002'}, {'value': '0.215', 'spread': '0.029', 'groupId': 'OG003'}, {'value': '0.122', 'spread': '0.029', 'groupId': 'OG004'}, {'value': '0.253', 'spread': '0.029', 'groupId': 'OG005'}, {'value': '0.253', 'spread': '0.029', 'groupId': 'OG006'}, {'value': '0.249', 'spread': '0.029', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.099', 'ciLowerLimit': '0.040', 'ciUpperLimit': '0.159', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.120', 'ciLowerLimit': '0.061', 'ciUpperLimit': '0.179', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.100', 'ciLowerLimit': '0.041', 'ciUpperLimit': '0.160', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.020', 'ciLowerLimit': '-0.039', 'ciUpperLimit': '0.079', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.001', 'ciLowerLimit': '-0.059', 'ciUpperLimit': '0.061', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.031', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.019', 'ciLowerLimit': '-0.079', 'ciUpperLimit': '0.040', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.131', 'ciLowerLimit': '0.071', 'ciUpperLimit': '0.190', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.131', 'ciLowerLimit': '0.072', 'ciUpperLimit': '0.191', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.127', 'ciLowerLimit': '0.067', 'ciUpperLimit': '0.187', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.001', 'ciLowerLimit': '-0.059', 'ciUpperLimit': '0.061', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.031', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.004', 'ciLowerLimit': '-0.063', 'ciUpperLimit': '0.056', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.004', 'ciLowerLimit': '-0.064', 'ciUpperLimit': '0.055', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29', 'description': 'Adjusted means of trough FVC (forced vital capacity) response \\[L\\] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all patients who were dispensed study medication and who provided baseline and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.'}, {'type': 'SECONDARY', 'title': 'FEV1 AUC 0-3h and FEV1 AUC 0-6h Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'title': 'AUC 0-3h', 'categories': [{'measurements': [{'value': '0.183', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '0.258', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '0.280', 'spread': '0.020', 'groupId': 'OG002'}, {'value': '0.302', 'spread': '0.020', 'groupId': 'OG003'}, {'value': '0.191', 'spread': '0.020', 'groupId': 'OG004'}, {'value': '0.288', 'spread': '0.020', 'groupId': 'OG005'}, {'value': '0.319', 'spread': '0.020', 'groupId': 'OG006'}, {'value': '0.334', 'spread': '0.020', 'groupId': 'OG007'}]}]}, {'title': 'AUC 0-6h', 'categories': [{'measurements': [{'value': '0.188', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '0.267', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '0.287', 'spread': '0.020', 'groupId': 'OG002'}, {'value': '0.307', 'spread': '0.020', 'groupId': 'OG003'}, {'value': '0.198', 'spread': '0.020', 'groupId': 'OG004'}, {'value': '0.296', 'spread': '0.020', 'groupId': 'OG005'}, {'value': '0.320', 'spread': '0.020', 'groupId': 'OG006'}, {'value': '0.342', 'spread': '0.020', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.075', 'ciLowerLimit': '0.035', 'ciUpperLimit': '0.114', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.097', 'ciLowerLimit': '0.057', 'ciUpperLimit': '0.137', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.119', 'ciLowerLimit': '0.079', 'ciUpperLimit': '0.159', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.022', 'ciLowerLimit': '-0.017', 'ciUpperLimit': '0.062', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.045', 'ciLowerLimit': '0.004', 'ciUpperLimit': '0.085', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.021', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.022', 'ciLowerLimit': '-0.018', 'ciUpperLimit': '0.062', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.097', 'ciLowerLimit': '0.057', 'ciUpperLimit': '0.137', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.128', 'ciLowerLimit': '0.088', 'ciUpperLimit': '0.168', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.143', 'ciLowerLimit': '0.103', 'ciUpperLimit': '0.183', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.031', 'ciLowerLimit': '-0.009', 'ciUpperLimit': '0.071', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.046', 'ciLowerLimit': '0.006', 'ciUpperLimit': '0.086', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.015', 'ciLowerLimit': '-0.025', 'ciUpperLimit': '0.055', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated 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as T+O 2.5/5 minus Olo 5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.118', 'ciLowerLimit': '0.080', 'ciUpperLimit': '0.157', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.020', 'ciLowerLimit': '-0.018', 'ciUpperLimit': '0.058', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'estimateComment': 'Difference calculated as T+O 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T+O 5/5 minus T+O 2.5/5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.098', 'ciLowerLimit': '0.060', 'ciUpperLimit': '0.136', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.121', 'ciLowerLimit': '0.083', 'ciUpperLimit': '0.159', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.144', 'ciLowerLimit': '0.105', 'ciUpperLimit': '0.182', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.023', 'ciLowerLimit': '-0.016', 'ciUpperLimit': '0.062', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.046', 'ciLowerLimit': '0.007', 'ciUpperLimit': '0.084', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.023', 'ciLowerLimit': '-0.016', 'ciUpperLimit': '0.061', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29', 'description': 'Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses \\[L\\] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'FEV1 AUC 0-3h Response After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.204', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.181', 'spread': '0.017', 'groupId': 'OG001'}, {'value': '0.209', 'spread': '0.017', 'groupId': 'OG002'}, {'value': '0.205', 'spread': '0.017', 'groupId': 'OG003'}, {'value': '0.188', 'spread': '0.017', 'groupId': 'OG004'}, {'value': '0.227', 'spread': '0.017', 'groupId': 'OG005'}, {'value': '0.219', 'spread': '0.017', 'groupId': 'OG006'}, {'value': '0.230', 'spread': '0.017', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.023', 'ciLowerLimit': '-0.058', 'ciUpperLimit': '0.012', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.005', 'ciLowerLimit': '-0.029', 'ciUpperLimit': '0.040', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.001', 'ciLowerLimit': '-0.034', 'ciUpperLimit': '0.036', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.028', 'ciLowerLimit': '-0.006', 'ciUpperLimit': '0.063', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.024', 'ciLowerLimit': '-0.011', 'ciUpperLimit': '0.059', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.004', 'ciLowerLimit': '-0.039', 'ciUpperLimit': '0.031', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.039', 'ciLowerLimit': '0.004', 'ciUpperLimit': '0.073', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.031', 'ciLowerLimit': '-0.004', 'ciUpperLimit': '0.066', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.041', 'ciLowerLimit': '0.006', 'ciUpperLimit': '0.076', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'ciLowerLimit': '-0.043', 'ciUpperLimit': '0.027', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.003', 'ciLowerLimit': '-0.032', 'ciUpperLimit': '0.037', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.010', 'ciLowerLimit': '-0.025', 'ciUpperLimit': '0.045', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1', 'description': 'Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response \\[L\\] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'FEV1 Peak 0-3h Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.264', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.353', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.355', 'spread': '0.023', 'groupId': 'OG002'}, {'value': '0.379', 'spread': '0.023', 'groupId': 'OG003'}, {'value': '0.267', 'spread': '0.023', 'groupId': 'OG004'}, {'value': '0.374', 'spread': '0.023', 'groupId': 'OG005'}, {'value': '0.399', 'spread': '0.023', 'groupId': 'OG006'}, {'value': '0.412', 'spread': '0.023', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.089', 'ciLowerLimit': '0.041', 'ciUpperLimit': '0.138', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.091', 'ciLowerLimit': '0.043', 'ciUpperLimit': '0.139', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.115', 'ciLowerLimit': '0.066', 'ciUpperLimit': '0.164', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.002', 'ciLowerLimit': '-0.046', 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'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.107', 'ciLowerLimit': '0.059', 'ciUpperLimit': '0.156', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.132', 'ciLowerLimit': '0.084', 'ciUpperLimit': '0.181', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.145', 'ciLowerLimit': '0.096', 'ciUpperLimit': '0.193', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.025', 'ciLowerLimit': '-0.024', 'ciUpperLimit': '0.074', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 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'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29', 'description': 'Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response \\[L\\] after 4 weeks of treatment. 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{'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.071', 'ciUpperLimit': '0.048', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.020', 'ciLowerLimit': '-0.079', 'ciUpperLimit': '0.039', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.175', 'ciLowerLimit': '0.116', 'ciUpperLimit': '0.234', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.175', 'ciLowerLimit': '0.116', 'ciUpperLimit': '0.234', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.200', 'ciLowerLimit': '0.140', 'ciUpperLimit': '0.259', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.000', 'ciLowerLimit': '-0.060', 'ciUpperLimit': '0.059', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.024', 'ciLowerLimit': '-0.035', 'ciUpperLimit': '0.083', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.024', 'ciLowerLimit': '-0.035', 'ciUpperLimit': '0.083', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.139', 'ciLowerLimit': '0.081', 'ciUpperLimit': '0.197', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.150', 'ciLowerLimit': '0.092', 'ciUpperLimit': '0.207', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.131', 'ciLowerLimit': '0.073', 'ciUpperLimit': '0.189', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.011', 'ciLowerLimit': '-0.047', 'ciUpperLimit': '0.068', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'ciLowerLimit': '-0.066', 'ciUpperLimit': '0.051', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.018', 'ciLowerLimit': '-0.076', 'ciUpperLimit': '0.039', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.189', 'ciLowerLimit': '0.131', 'ciUpperLimit': '0.247', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.179', 'ciLowerLimit': '0.121', 'ciUpperLimit': '0.236', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.213', 'ciLowerLimit': '0.155', 'ciUpperLimit': '0.271', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.010', 'ciLowerLimit': '-0.069', 'ciUpperLimit': '0.048', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.024', 'ciLowerLimit': '-0.033', 'ciUpperLimit': '0.082', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.035', 'ciLowerLimit': '-0.023', 'ciUpperLimit': '0.092', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29', 'description': 'Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses \\[L\\] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'FVC AUC 0-3h Response After First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.333', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.285', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.326', 'spread': '0.029', 'groupId': 'OG002'}, {'value': '0.319', 'spread': '0.030', 'groupId': 'OG003'}, {'value': '0.303', 'spread': '0.029', 'groupId': 'OG004'}, {'value': '0.393', 'spread': '0.030', 'groupId': 'OG005'}, {'value': '0.363', 'spread': '0.029', 'groupId': 'OG006'}, {'value': '0.359', 'spread': '0.029', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.048', 'ciLowerLimit': '-0.106', 'ciUpperLimit': '0.010', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.007', 'ciLowerLimit': '-0.065', 'ciUpperLimit': '0.051', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.014', 'ciLowerLimit': '-0.072', 'ciUpperLimit': '0.044', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.041', 'ciLowerLimit': '-0.017', 'ciUpperLimit': '0.099', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.034', 'ciLowerLimit': '-0.024', 'ciUpperLimit': '0.093', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.007', 'ciLowerLimit': '-0.065', 'ciUpperLimit': '0.051', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.090', 'ciLowerLimit': '0.032', 'ciUpperLimit': '0.148', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.059', 'ciLowerLimit': '0.001', 'ciUpperLimit': '0.118', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.056', 'ciLowerLimit': '-0.002', 'ciUpperLimit': '0.114', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.031', 'ciLowerLimit': '-0.089', 'ciUpperLimit': '0.028', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.034', 'ciLowerLimit': '-0.092', 'ciUpperLimit': '0.024', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.003', 'ciLowerLimit': '-0.062', 'ciUpperLimit': '0.055', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1', 'description': 'Adjusted means of the FVC AUC 0-3h response \\[L\\] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'FVC Peak 0-3h Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.415', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.570', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '0.563', 'spread': '0.035', 'groupId': 'OG002'}, {'value': '0.542', 'spread': '0.035', 'groupId': 'OG003'}, {'value': '0.411', 'spread': '0.035', 'groupId': 'OG004'}, {'value': '0.585', 'spread': '0.035', 'groupId': 'OG005'}, {'value': '0.593', 'spread': '0.035', 'groupId': 'OG006'}, {'value': '0.615', 'spread': '0.035', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.155', 'ciLowerLimit': '0.087', 'ciUpperLimit': '0.223', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.147', 'ciLowerLimit': '0.079', 'ciUpperLimit': '0.215', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.127', 'ciLowerLimit': '0.058', 'ciUpperLimit': '0.195', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'ciLowerLimit': '-0.075', 'ciUpperLimit': '0.060', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.028', 'ciLowerLimit': '-0.097', 'ciUpperLimit': '0.041', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.020', 'ciLowerLimit': '-0.089', 'ciUpperLimit': '0.048', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.174', 'ciLowerLimit': '0.106', 'ciUpperLimit': '0.242', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.182', 'ciLowerLimit': '0.113', 'ciUpperLimit': '0.250', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.204', 'ciLowerLimit': '0.135', 'ciUpperLimit': '0.272', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.008', 'ciLowerLimit': '-0.061', 'ciUpperLimit': '0.076', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.030', 'ciLowerLimit': '-0.038', 'ciUpperLimit': '0.098', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.022', 'ciLowerLimit': '-0.046', 'ciUpperLimit': '0.090', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29', 'description': 'Adjusted means of the FVC peak 0-3h response \\[L\\] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'FVC Peak 0-3h Response After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.473', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.423', 'spread': '0.031', 'groupId': 'OG001'}, {'value': '0.481', 'spread': '0.031', 'groupId': 'OG002'}, {'value': '0.462', 'spread': '0.032', 'groupId': 'OG003'}, {'value': '0.436', 'spread': '0.031', 'groupId': 'OG004'}, {'value': '0.547', 'spread': '0.032', 'groupId': 'OG005'}, {'value': '0.517', 'spread': '0.031', 'groupId': 'OG006'}, {'value': '0.505', 'spread': '0.031', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.051', 'ciLowerLimit': '-0.114', 'ciUpperLimit': '0.013', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.008', 'ciLowerLimit': '-0.055', 'ciUpperLimit': '0.071', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.011', 'ciLowerLimit': '-0.074', 'ciUpperLimit': '0.053', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.059', 'ciLowerLimit': '-0.004', 'ciUpperLimit': '0.122', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.040', 'ciLowerLimit': '-0.024', 'ciUpperLimit': '0.104', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.019', 'ciLowerLimit': '-0.082', 'ciUpperLimit': '0.045', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 5/5 minus +O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.111', 'ciLowerLimit': '0.047', 'ciUpperLimit': '0.174', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.081', 'ciLowerLimit': '0.017', 'ciUpperLimit': '0.144', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.069', 'ciLowerLimit': '0.005', 'ciUpperLimit': '0.132', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.030', 'ciLowerLimit': '-0.094', 'ciUpperLimit': '0.034', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.042', 'ciLowerLimit': '-0.105', 'ciUpperLimit': '0.021', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.075', 'ciUpperLimit': '0.052', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1', 'description': 'Adjusted mean of the FVC peak 0-3h response \\[L\\] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'PEF AUC 0-3h and AUC 0-6h Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'title': 'AUC 0-3h', 'categories': [{'measurements': [{'value': '25.542', 'spread': '4.190', 'groupId': 'OG000'}, {'value': '44.301', 'spread': '4.202', 'groupId': 'OG001'}, {'value': '50.698', 'spread': '4.167', 'groupId': 'OG002'}, {'value': '55.346', 'spread': '4.234', 'groupId': 'OG003'}, {'value': '29.713', 'spread': '4.183', 'groupId': 'OG004'}, {'value': '48.032', 'spread': '4.218', 'groupId': 'OG005'}, {'value': '53.224', 'spread': '4.192', 'groupId': 'OG006'}, {'value': '52.531', 'spread': '4.205', 'groupId': 'OG007'}]}]}, {'title': 'AUC 0-6h', 'categories': [{'measurements': [{'value': '28.071', 'spread': '4.125', 'groupId': 'OG000'}, {'value': '46.822', 'spread': '4.136', 'groupId': 'OG001'}, {'value': '54.081', 'spread': '4.104', 'groupId': 'OG002'}, {'value': '57.418', 'spread': '4.166', 'groupId': 'OG003'}, {'value': '31.831', 'spread': '4.119', 'groupId': 'OG004'}, {'value': '51.485', 'spread': '4.151', 'groupId': 'OG005'}, {'value': '54.593', 'spread': '4.127', 'groupId': 'OG006'}, {'value': '57.367', 'spread': '4.139', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.759', 'ciLowerLimit': '10.533', 'ciUpperLimit': '26.985', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.189', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.157', 'ciLowerLimit': '16.962', 'ciUpperLimit': '33.351', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.173', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.804', 'ciLowerLimit': '21.526', 'ciUpperLimit': '38.082', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.216', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.398', 'ciLowerLimit': '-1.796', 'ciUpperLimit': '14.592', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.173', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.046', 'ciLowerLimit': '2.721', 'ciUpperLimit': '19.370', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.239', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.648', 'ciLowerLimit': '-3.608', 'ciUpperLimit': '12.903', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.204', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.318', 'ciLowerLimit': '10.068', 'ciUpperLimit': '26.568', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.201', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.511', 'ciLowerLimit': '15.270', 'ciUpperLimit': '31.752', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.197', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.817', 'ciLowerLimit': '14.543', 'ciUpperLimit': '31.092', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.214', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.193', 'ciLowerLimit': '-3.115', 'ciUpperLimit': '13.500', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.230', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.499', 'ciLowerLimit': '-3.719', 'ciUpperLimit': '12.717', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.185', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.694', 'ciLowerLimit': '-8.941', 'ciUpperLimit': '7.554', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.200', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'groupDescription': 'AUC 0-3h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.751', 'ciLowerLimit': '10.870', 'ciUpperLimit': '26.632', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.013', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.009', 'ciLowerLimit': '18.158', 'ciUpperLimit': '33.860', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.998', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.347', 'ciLowerLimit': '21.416', 'ciUpperLimit': '37.278', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.039', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.259', 'ciLowerLimit': '-0.592', 'ciUpperLimit': '15.109', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.998', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.596', 'ciLowerLimit': '2.621', 'ciUpperLimit': '18.571', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.061', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.337', 'ciLowerLimit': '-4.572', 'ciUpperLimit': '11.247', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.028', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.654', 'ciLowerLimit': '11.750', 'ciUpperLimit': '27.558', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.025', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.762', 'ciLowerLimit': '14.866', 'ciUpperLimit': '30.659', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.021', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.536', 'ciLowerLimit': '17.607', 'ciUpperLimit': '33.464', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.038', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.108', 'ciLowerLimit': '-4.852', 'ciUpperLimit': '11.067', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.053', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.881', 'ciLowerLimit': '-1.991', 'ciUpperLimit': '13.754', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.009', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.773', 'ciLowerLimit': '-5.129', 'ciUpperLimit': '10.675', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.024', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'groupDescription': 'AUC 0-6h', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29', 'description': 'Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'PEF AUC 0-3h Response After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.575', 'spread': '4.047', 'groupId': 'OG000'}, {'value': '32.891', 'spread': '4.050', 'groupId': 'OG001'}, {'value': '35.053', 'spread': '4.022', 'groupId': 'OG002'}, {'value': '35.243', 'spread': '4.084', 'groupId': 'OG003'}, {'value': '31.724', 'spread': '4.040', 'groupId': 'OG004'}, {'value': '33.213', 'spread': '4.079', 'groupId': 'OG005'}, {'value': '34.987', 'spread': '4.051', 'groupId': 'OG006'}, {'value': '38.846', 'spread': '4.065', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.316', 'ciLowerLimit': '-6.268', 'ciUpperLimit': '10.900', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.371', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.478', 'ciLowerLimit': '-4.088', 'ciUpperLimit': '13.044', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.362', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.668', 'ciLowerLimit': '-3.978', 'ciUpperLimit': '13.314', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.403', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.162', 'ciLowerLimit': '-6.379', 'ciUpperLimit': '10.702', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.349', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.352', 'ciLowerLimit': '-6.326', 'ciUpperLimit': '11.029', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.419', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.190', 'ciLowerLimit': '-8.430', 'ciUpperLimit': '8.810', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.390', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.488', 'ciLowerLimit': '-7.136', 'ciUpperLimit': '10.113', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.392', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.262', 'ciLowerLimit': '-5.350', 'ciUpperLimit': '11.875', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.386', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.121', 'ciLowerLimit': '-1.535', 'ciUpperLimit': '15.778', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.408', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.774', 'ciLowerLimit': '-6.910', 'ciUpperLimit': '10.458', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.423', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.663', 'ciLowerLimit': '-2.970', 'ciUpperLimit': '14.236', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.381', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.859', 'ciLowerLimit': '-4.786', 'ciUpperLimit': '12.504', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.403', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1', 'description': 'Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'PEF Peak 0-3h Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.010', 'spread': '4.566', 'groupId': 'OG000'}, {'value': '64.693', 'spread': '4.581', 'groupId': 'OG001'}, {'value': '69.610', 'spread': '4.538', 'groupId': 'OG002'}, {'value': '76.108', 'spread': '4.620', 'groupId': 'OG003'}, {'value': '49.025', 'spread': '4.557', 'groupId': 'OG004'}, {'value': '66.767', 'spread': '4.600', 'groupId': 'OG005'}, {'value': '73.140', 'spread': '4.569', 'groupId': 'OG006'}, {'value': '74.120', 'spread': '4.584', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.682', 'ciLowerLimit': '9.161', 'ciUpperLimit': '28.204', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.849', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.599', 'ciLowerLimit': '14.116', 'ciUpperLimit': '33.083', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.830', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.097', 'ciLowerLimit': '20.517', 'ciUpperLimit': '39.677', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.879', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.917', 'ciLowerLimit': '-4.568', 'ciUpperLimit': '14.402', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.830', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.415', 'ciLowerLimit': '1.780', 'ciUpperLimit': '21.050', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.907', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.498', 'ciLowerLimit': '-3.057', 'ciUpperLimit': '16.053', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.866', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.742', 'ciLowerLimit': '8.194', 'ciUpperLimit': '27.290', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.862', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.115', 'ciLowerLimit': '14.580', 'ciUpperLimit': '33.651', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.856', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.095', 'ciLowerLimit': '15.520', 'ciUpperLimit': '34.670', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.876', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.373', 'ciLowerLimit': '-3.240', 'ciUpperLimit': '15.986', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.896', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.353', 'ciLowerLimit': '-2.161', 'ciUpperLimit': '16.866', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.845', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.980', 'ciLowerLimit': '-8.566', 'ciUpperLimit': '10.525', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.861', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29', 'description': 'Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'PEF Peak 0-3h Response After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.129', 'spread': '4.363', 'groupId': 'OG000'}, {'value': '53.298', 'spread': '4.366', 'groupId': 'OG001'}, {'value': '56.565', 'spread': '4.335', 'groupId': 'OG002'}, {'value': '57.318', 'spread': '4.406', 'groupId': 'OG003'}, {'value': '51.980', 'spread': '4.355', 'groupId': 'OG004'}, {'value': '54.966', 'spread': '4.400', 'groupId': 'OG005'}, {'value': '56.896', 'spread': '4.367', 'groupId': 'OG006'}, {'value': '59.412', 'spread': '4.370', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.170', 'ciLowerLimit': '-8.360', 'ciUpperLimit': '10.699', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.853', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.436', 'ciLowerLimit': '-5.073', 'ciUpperLimit': '13.945', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.843', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.189', 'ciLowerLimit': '-4.407', 'ciUpperLimit': '14.785', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.887', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.267', 'ciLowerLimit': '-6.214', 'ciUpperLimit': '12.747', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.828', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.020', 'ciLowerLimit': '-5.610', 'ciUpperLimit': '13.650', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.904', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.753', 'ciLowerLimit': '-8.816', 'ciUpperLimit': '10.322', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.873', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.986', 'ciLowerLimit': '-6.589', 'ciUpperLimit': '12.561', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.876', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.916', 'ciLowerLimit': '-4.643', 'ciUpperLimit': '14.475', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.868', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.432', 'ciLowerLimit': '-2.154', 'ciUpperLimit': '17.019', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.882', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.930', 'ciLowerLimit': '-7.708', 'ciUpperLimit': '11.568', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.909', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.446', 'ciLowerLimit': '-5.085', 'ciUpperLimit': '13.978', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.854', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.517', 'ciLowerLimit': '-7.046', 'ciUpperLimit': '12.079', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.870', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1', 'description': 'Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Individual FEV1 Measurements at Each Time Point on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'title': 'Timepoint -1:00 hr response', 'categories': [{'measurements': [{'value': '1.410', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '1.464', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '1.481', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '1.491', 'spread': '0.018', 'groupId': 'OG003'}, {'value': '1.414', 'spread': '0.018', 'groupId': 'OG004'}, {'value': '1.467', 'spread': '0.018', 'groupId': 'OG005'}, {'value': '1.504', 'spread': '0.018', 'groupId': 'OG006'}, {'value': '1.500', 'spread': '0.018', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint -0:10 hr response', 'categories': [{'measurements': [{'value': '1.431', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '1.487', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '1.488', 'spread': '0.020', 'groupId': 'OG002'}, {'value': '1.516', 'spread': '0.020', 'groupId': 'OG003'}, {'value': '1.447', 'spread': '0.020', 'groupId': 'OG004'}, {'value': '1.498', 'spread': '0.020', 'groupId': 'OG005'}, {'value': '1.526', 'spread': '0.020', 'groupId': 'OG006'}, {'value': '1.527', 'spread': '0.020', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 0:00 hr response', 'categories': [{'measurements': [{'value': '1.419', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '1.473', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '1.484', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '1.503', 'spread': '0.018', 'groupId': 'OG003'}, {'value': '1.431', 'spread': '0.018', 'groupId': 'OG004'}, {'value': '1.482', 'spread': '0.018', 'groupId': 'OG005'}, {'value': '1.514', 'spread': '0.018', 'groupId': 'OG006'}, {'value': '1.511', 'spread': '0.018', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 0:05 hr response', 'categories': [{'measurements': [{'value': '1.483', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '1.555', 'spread': '0.022', 'groupId': 'OG001'}, {'value': '1.553', 'spread': '0.022', 'groupId': 'OG002'}, {'value': '1.563', 'spread': '0.022', 'groupId': 'OG003'}, {'value': '1.491', 'spread': '0.022', 'groupId': 'OG004'}, {'value': '1.576', 'spread': '0.022', 'groupId': 'OG005'}, {'value': '1.593', 'spread': '0.022', 'groupId': 'OG006'}, {'value': '1.601', 'spread': '0.022', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 0:30 hr response', 'categories': [{'measurements': [{'value': '1.516', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '1.570', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '1.597', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '1.630', 'spread': '0.021', 'groupId': 'OG003'}, {'value': '1.524', 'spread': '0.021', 'groupId': 'OG004'}, {'value': '1.605', 'spread': '0.021', 'groupId': 'OG005'}, {'value': '1.643', 'spread': '0.021', 'groupId': 'OG006'}, {'value': '1.660', 'spread': '0.021', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 1:00 hr response', 'categories': [{'measurements': [{'value': '1.521', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '1.595', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '1.622', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '1.633', 'spread': '0.021', 'groupId': 'OG003'}, {'value': '1.527', 'spread': '0.021', 'groupId': 'OG004'}, {'value': '1.627', 'spread': '0.021', 'groupId': 'OG005'}, {'value': '1.658', 'spread': '0.021', 'groupId': 'OG006'}, {'value': '1.675', 'spread': '0.021', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 2:00 hr response', 'categories': [{'measurements': [{'value': '1.552', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '1.625', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '1.656', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '1.687', 'spread': '0.022', 'groupId': 'OG003'}, {'value': '1.556', 'spread': '0.021', 'groupId': 'OG004'}, {'value': '1.661', 'spread': '0.021', 'groupId': 'OG005'}, {'value': '1.699', 'spread': '0.021', 'groupId': 'OG006'}, {'value': '1.711', 'spread': '0.021', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 3:00 hr response', 'categories': [{'measurements': [{'value': '1.553', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '1.648', 'spread': '0.022', 'groupId': 'OG001'}, {'value': '1.659', 'spread': '0.022', 'groupId': 'OG002'}, {'value': '1.671', 'spread': '0.022', 'groupId': 'OG003'}, {'value': '1.567', 'spread': '0.022', 'groupId': 'OG004'}, {'value': '1.671', 'spread': '0.022', 'groupId': 'OG005'}, {'value': '1.690', 'spread': '0.022', 'groupId': 'OG006'}, {'value': '1.716', 'spread': '0.022', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 4:00 hr response', 'categories': [{'measurements': [{'value': '1.543', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '1.621', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '1.654', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '1.659', 'spread': '0.021', 'groupId': 'OG003'}, {'value': '1.563', 'spread': '0.021', 'groupId': 'OG004'}, {'value': '1.663', 'spread': '0.021', 'groupId': 'OG005'}, {'value': '1.676', 'spread': '0.021', 'groupId': 'OG006'}, {'value': '1.708', 'spread': '0.021', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 5:00 hr response', 'categories': [{'measurements': [{'value': '1.549', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '1.622', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '1.626', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '1.654', 'spread': '0.021', 'groupId': 'OG003'}, {'value': '1.540', 'spread': '0.021', 'groupId': 'OG004'}, {'value': '1.640', 'spread': '0.021', 'groupId': 'OG005'}, {'value': '1.655', 'spread': '0.021', 'groupId': 'OG006'}, {'value': '1.688', 'spread': '0.021', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 6:00 hr response', 'categories': [{'measurements': [{'value': '1.517', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '1.605', 'spread': '0.022', 'groupId': 'OG001'}, {'value': '1.631', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '1.647', 'spread': '0.022', 'groupId': 'OG003'}, {'value': '1.547', 'spread': '0.022', 'groupId': 'OG004'}, {'value': '1.636', 'spread': '0.022', 'groupId': 'OG005'}, {'value': '1.656', 'spread': '0.022', 'groupId': 'OG006'}, {'value': '1.687', 'spread': '0.022', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29', 'description': 'Adjusted means of the FEV1 measurements \\[L\\] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Individual FVC Measurements at Each Time Point on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'title': 'Timepoint -1:00 hr response', 'categories': [{'measurements': [{'value': '2.877', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '2.961', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '2.996', 'spread': '0.029', 'groupId': 'OG002'}, {'value': '2.954', 'spread': '0.029', 'groupId': 'OG003'}, {'value': '2.877', 'spread': '0.029', 'groupId': 'OG004'}, {'value': '3.006', 'spread': '0.029', 'groupId': 'OG005'}, {'value': '3.012', 'spread': '0.029', 'groupId': 'OG006'}, {'value': '3.007', 'spread': '0.029', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint -0:10 hr response', 'categories': [{'measurements': [{'value': '2.891', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '3.007', 'spread': '0.032', 'groupId': 'OG001'}, {'value': '3.009', 'spread': '0.031', 'groupId': 'OG002'}, {'value': '3.012', 'spread': '0.032', 'groupId': 'OG003'}, {'value': '2.904', 'spread': '0.032', 'groupId': 'OG004'}, {'value': '3.036', 'spread': '0.032', 'groupId': 'OG005'}, {'value': '3.032', 'spread': '0.032', 'groupId': 'OG006'}, {'value': '3.032', 'spread': '0.032', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 0:00 hr response', 'categories': [{'measurements': [{'value': '2.882', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '2.981', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '3.002', 'spread': '0.029', 'groupId': 'OG002'}, {'value': '2.982', 'spread': '0.029', 'groupId': 'OG003'}, {'value': '2.889', 'spread': '0.029', 'groupId': 'OG004'}, {'value': '3.020', 'spread': '0.029', 'groupId': 'OG005'}, {'value': '3.020', 'spread': '0.029', 'groupId': 'OG006'}, {'value': '3.016', 'spread': '0.029', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 0:05 hr response', 'categories': [{'measurements': [{'value': '2.999', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '3.130', 'spread': '0.033', 'groupId': 'OG001'}, {'value': '3.120', 'spread': '0.033', 'groupId': 'OG002'}, {'value': '3.087', 'spread': '0.033', 'groupId': 'OG003'}, {'value': '3.009', 'spread': '0.033', 'groupId': 'OG004'}, {'value': '3.141', 'spread': '0.033', 'groupId': 'OG005'}, {'value': '3.147', 'spread': '0.033', 'groupId': 'OG006'}, {'value': '3.148', 'spread': '0.033', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 0:30 hr response', 'categories': [{'measurements': [{'value': '3.018', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '3.171', 'spread': '0.033', 'groupId': 'OG001'}, {'value': '3.145', 'spread': '0.033', 'groupId': 'OG002'}, {'value': '3.172', 'spread': '0.034', 'groupId': 'OG003'}, {'value': '3.019', 'spread': '0.033', 'groupId': 'OG004'}, {'value': '3.190', 'spread': '0.034', 'groupId': 'OG005'}, {'value': '3.192', 'spread': '0.033', 'groupId': 'OG006'}, {'value': '3.219', 'spread': '0.033', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 1:00 hr response', 'categories': [{'measurements': [{'value': '3.036', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '3.174', 'spread': '0.034', 'groupId': 'OG001'}, {'value': '3.190', 'spread': '0.034', 'groupId': 'OG002'}, {'value': '3.162', 'spread': '0.034', 'groupId': 'OG003'}, {'value': '3.032', 'spread': '0.034', 'groupId': 'OG004'}, {'value': '3.204', 'spread': '0.034', 'groupId': 'OG005'}, {'value': '3.215', 'spread': '0.034', 'groupId': 'OG006'}, {'value': '3.239', 'spread': '0.034', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 2:00 hr response', 'categories': [{'measurements': [{'value': '3.077', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '3.216', 'spread': '0.034', 'groupId': 'OG001'}, {'value': '3.234', 'spread': '0.034', 'groupId': 'OG002'}, {'value': '3.208', 'spread': '0.035', 'groupId': 'OG003'}, {'value': '3.071', 'spread': '0.034', 'groupId': 'OG004'}, {'value': '3.258', 'spread': '0.035', 'groupId': 'OG005'}, {'value': '3.249', 'spread': '0.034', 'groupId': 'OG006'}, {'value': '3.275', 'spread': '0.034', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 3:00 hr response', 'categories': [{'measurements': [{'value': '3.067', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '3.222', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '3.233', 'spread': '0.035', 'groupId': 'OG002'}, {'value': '3.200', 'spread': '0.036', 'groupId': 'OG003'}, {'value': '3.081', 'spread': '0.035', 'groupId': 'OG004'}, {'value': '3.264', 'spread': '0.036', 'groupId': 'OG005'}, {'value': '3.267', 'spread': '0.035', 'groupId': 'OG006'}, {'value': '3.303', 'spread': '0.035', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 4:00 hr response', 'categories': [{'measurements': [{'value': '3.054', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '3.181', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '3.204', 'spread': '0.034', 'groupId': 'OG002'}, {'value': '3.183', 'spread': '0.035', 'groupId': 'OG003'}, {'value': '3.054', 'spread': '0.034', 'groupId': 'OG004'}, {'value': '3.266', 'spread': '0.035', 'groupId': 'OG005'}, {'value': '3.227', 'spread': '0.035', 'groupId': 'OG006'}, {'value': '3.281', 'spread': '0.035', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 5:00 hr response', 'categories': [{'measurements': [{'value': '3.061', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '3.193', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '3.188', 'spread': '0.035', 'groupId': 'OG002'}, {'value': '3.178', 'spread': '0.035', 'groupId': 'OG003'}, {'value': '3.019', 'spread': '0.035', 'groupId': 'OG004'}, {'value': '3.222', 'spread': '0.035', 'groupId': 'OG005'}, {'value': '3.214', 'spread': '0.035', 'groupId': 'OG006'}, {'value': '3.252', 'spread': '0.035', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 6:00 hr response', 'categories': [{'measurements': [{'value': '3.035', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '3.163', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '3.197', 'spread': '0.035', 'groupId': 'OG002'}, {'value': '3.179', 'spread': '0.035', 'groupId': 'OG003'}, {'value': '3.028', 'spread': '0.035', 'groupId': 'OG004'}, {'value': '3.228', 'spread': '0.035', 'groupId': 'OG005'}, {'value': '3.208', 'spread': '0.035', 'groupId': 'OG006'}, {'value': '3.261', 'spread': '0.035', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29', 'description': 'Adjusted means of the FVC measurements \\[L\\] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Individual PEF Measurements at Each Time Point on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'title': 'Timepoint -1:00 hr response', 'categories': [{'measurements': [{'value': '246.557', 'spread': '4.061', 'groupId': 'OG000'}, {'value': '260.901', 'spread': '4.064', 'groupId': 'OG001'}, {'value': '263.662', 'spread': '4.037', 'groupId': 'OG002'}, {'value': '269.754', 'spread': '4.110', 'groupId': 'OG003'}, {'value': '249.356', 'spread': '4.054', 'groupId': 'OG004'}, {'value': '263.134', 'spread': '4.092', 'groupId': 'OG005'}, {'value': '267.013', 'spread': '4.064', 'groupId': 'OG006'}, {'value': '266.913', 'spread': '4.067', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint -0:10 hr response', 'categories': [{'measurements': [{'value': '245.661', 'spread': '4.165', 'groupId': 'OG000'}, {'value': '264.412', 'spread': '4.180', 'groupId': 'OG001'}, {'value': '265.177', 'spread': '4.139', 'groupId': 'OG002'}, {'value': '271.793', 'spread': '4.204', 'groupId': 'OG003'}, {'value': '253.921', 'spread': '4.157', 'groupId': 'OG004'}, {'value': '264.808', 'spread': '4.211', 'groupId': 'OG005'}, {'value': '268.772', 'spread': '4.168', 'groupId': 'OG006'}, {'value': '266.506', 'spread': '4.183', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 0:00 hr response', 'categories': [{'measurements': [{'value': '245.758', 'spread': '3.892', 'groupId': 'OG000'}, {'value': '262.239', 'spread': '3.895', 'groupId': 'OG001'}, {'value': '264.202', 'spread': '3.870', 'groupId': 'OG002'}, {'value': '270.565', 'spread': '3.926', 'groupId': 'OG003'}, {'value': '251.517', 'spread': '3.886', 'groupId': 'OG004'}, {'value': '263.757', 'spread': '3.921', 'groupId': 'OG005'}, {'value': '267.623', 'spread': '3.895', 'groupId': 'OG006'}, {'value': '266.187', 'spread': '3.898', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 0:05 hr response', 'categories': [{'measurements': [{'value': '254.967', 'spread': '4.259', 'groupId': 'OG000'}, {'value': '267.969', 'spread': '4.272', 'groupId': 'OG001'}, {'value': '273.340', 'spread': '4.235', 'groupId': 'OG002'}, {'value': '275.329', 'spread': '4.307', 'groupId': 'OG003'}, {'value': '259.301', 'spread': '4.252', 'groupId': 'OG004'}, {'value': '271.071', 'spread': '4.289', 'groupId': 'OG005'}, {'value': '276.004', 'spread': '4.262', 'groupId': 'OG006'}, {'value': '275.727', 'spread': '4.275', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 0:30 hr response', 'categories': [{'measurements': [{'value': '257.326', 'spread': '4.548', 'groupId': 'OG000'}, {'value': '275.045', 'spread': '4.563', 'groupId': 'OG001'}, {'value': '279.309', 'spread': '4.519', 'groupId': 'OG002'}, {'value': '286.288', 'spread': '4.603', 'groupId': 'OG003'}, {'value': '264.909', 'spread': '4.539', 'groupId': 'OG004'}, {'value': '280.836', 'spread': '4.582', 'groupId': 'OG005'}, {'value': '287.502', 'spread': '4.550', 'groupId': 'OG006'}, {'value': '288.289', 'spread': '4.566', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 1:00 hr response', 'categories': [{'measurements': [{'value': '261.890', 'spread': '4.420', 'groupId': 'OG000'}, {'value': '279.892', 'spread': '4.434', 'groupId': 'OG001'}, {'value': '287.635', 'spread': '4.393', 'groupId': 'OG002'}, {'value': '289.866', 'spread': '4.472', 'groupId': 'OG003'}, {'value': '263.293', 'spread': '4.412', 'groupId': 'OG004'}, {'value': '283.326', 'spread': '4.452', 'groupId': 'OG005'}, {'value': '288.427', 'spread': '4.422', 'groupId': 'OG006'}, {'value': '288.585', 'spread': '4.437', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 2:00 hr response', 'categories': [{'measurements': [{'value': '269.187', 'spread': '4.606', 'groupId': 'OG000'}, {'value': '287.181', 'spread': '4.621', 'groupId': 'OG001'}, {'value': '295.820', 'spread': '4.578', 'groupId': 'OG002'}, {'value': '300.076', 'spread': '4.661', 'groupId': 'OG003'}, {'value': '272.318', 'spread': '4.597', 'groupId': 'OG004'}, {'value': '291.503', 'spread': '4.640', 'groupId': 'OG005'}, {'value': '298.394', 'spread': '4.609', 'groupId': 'OG006'}, {'value': '294.627', 'spread': '4.625', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 3:00 hr response', 'categories': [{'measurements': [{'value': '269.067', 'spread': '4.649', 'groupId': 'OG000'}, {'value': '292.962', 'spread': '4.665', 'groupId': 'OG001'}, {'value': '296.736', 'spread': '4.620', 'groupId': 'OG002'}, {'value': '303.099', 'spread': '4.707', 'groupId': 'OG003'}, {'value': '274.334', 'spread': '4.641', 'groupId': 'OG004'}, {'value': '295.008', 'spread': '4.685', 'groupId': 'OG005'}, {'value': '296.641', 'spread': '4.652', 'groupId': 'OG006'}, {'value': '300.582', 'spread': '4.669', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 4:00 hr response', 'categories': [{'measurements': [{'value': '266.451', 'spread': '4.485', 'groupId': 'OG000'}, {'value': '286.382', 'spread': '4.499', 'groupId': 'OG001'}, {'value': '297.483', 'spread': '4.460', 'groupId': 'OG002'}, {'value': '297.415', 'spread': '4.536', 'groupId': 'OG003'}, {'value': '274.466', 'spread': '4.478', 'groupId': 'OG004'}, {'value': '293.986', 'spread': '4.517', 'groupId': 'OG005'}, {'value': '293.617', 'spread': '4.488', 'groupId': 'OG006'}, {'value': '302.539', 'spread': '4.502', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 5:00 hr response', 'categories': [{'measurements': [{'value': '272.141', 'spread': '4.500', 'groupId': 'OG000'}, {'value': '287.917', 'spread': '4.514', 'groupId': 'OG001'}, {'value': '293.878', 'spread': '4.474', 'groupId': 'OG002'}, {'value': '295.911', 'spread': '4.550', 'groupId': 'OG003'}, {'value': '269.220', 'spread': '4.492', 'groupId': 'OG004'}, {'value': '293.039', 'spread': '4.531', 'groupId': 'OG005'}, {'value': '294.713', 'spread': '4.502', 'groupId': 'OG006'}, {'value': '300.335', 'spread': '4.517', 'groupId': 'OG007'}]}]}, {'title': 'Timepoint 6:00 hr response', 'categories': [{'measurements': [{'value': '268.680', 'spread': '4.523', 'groupId': 'OG000'}, {'value': '284.028', 'spread': '4.537', 'groupId': 'OG001'}, {'value': '295.843', 'spread': '4.497', 'groupId': 'OG002'}, {'value': '295.703', 'spread': '4.575', 'groupId': 'OG003'}, {'value': '270.707', 'spread': '4.515', 'groupId': 'OG004'}, {'value': '290.283', 'spread': '4.556', 'groupId': 'OG005'}, {'value': '293.466', 'spread': '4.526', 'groupId': 'OG006'}, {'value': '299.234', 'spread': '4.541', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29', 'description': 'Adjusted means of the PEF measurements \\[L/min\\] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Weekly Mean Number of Puffs of Rescue Medication Used Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.511', 'spread': '0.146', 'groupId': 'OG000'}, {'value': '1.298', 'spread': '0.145', 'groupId': 'OG001'}, {'value': '1.191', 'spread': '0.147', 'groupId': 'OG002'}, {'value': '1.446', 'spread': '0.147', 'groupId': 'OG003'}, {'value': '1.423', 'spread': '0.145', 'groupId': 'OG004'}, {'value': '1.465', 'spread': '0.147', 'groupId': 'OG005'}, {'value': '1.172', 'spread': '0.146', 'groupId': 'OG006'}, {'value': '1.244', 'spread': '0.146', 'groupId': 'OG007'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.391', 'spread': '0.164', 'groupId': 'OG000'}, {'value': '1.502', 'spread': '0.163', 'groupId': 'OG001'}, {'value': '1.299', 'spread': '0.163', 'groupId': 'OG002'}, {'value': '1.444', 'spread': '0.164', 'groupId': 'OG003'}, {'value': '1.561', 'spread': '0.162', 'groupId': 'OG004'}, {'value': '1.344', 'spread': '0.165', 'groupId': 'OG005'}, {'value': '1.198', 'spread': '0.164', 'groupId': 'OG006'}, {'value': '1.315', 'spread': '0.163', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.212', 'ciLowerLimit': '-0.523', 'ciUpperLimit': '0.099', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.158', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.319', 'ciLowerLimit': '-0.634', 'ciUpperLimit': '-0.004', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.160', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.065', 'ciLowerLimit': '-0.379', 'ciUpperLimit': '0.249', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.160', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.107', 'ciLowerLimit': '-0.420', 'ciUpperLimit': '0.206', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.147', 'ciLowerLimit': '-0.168', 'ciUpperLimit': '0.462', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.160', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.255', 'ciLowerLimit': '-0.062', 'ciUpperLimit': '0.571', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.161', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.042', 'ciLowerLimit': '-0.271', 'ciUpperLimit': '0.355', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.160', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.251', 'ciLowerLimit': '-0.564', 'ciUpperLimit': '0.062', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.178', 'ciLowerLimit': '-0.492', 'ciUpperLimit': '0.135', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.160', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.293', 'ciLowerLimit': '-0.611', 'ciUpperLimit': '0.024', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.221', 'ciLowerLimit': '-0.533', 'ciUpperLimit': '0.092', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.073', 'ciLowerLimit': '-0.242', 'ciUpperLimit': '0.388', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.160', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.110', 'ciLowerLimit': '-0.241', 'ciUpperLimit': '0.462', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.179', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.092', 'ciLowerLimit': '-0.445', 'ciUpperLimit': '0.261', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.180', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.052', 'ciLowerLimit': '-0.301', 'ciUpperLimit': '0.406', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.180', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.202', 'ciLowerLimit': '-0.555', 'ciUpperLimit': '0.150', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.179', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.058', 'ciLowerLimit': '-0.411', 'ciUpperLimit': '0.296', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.180', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.144', 'ciLowerLimit': '-0.208', 'ciUpperLimit': '0.496', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.179', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.217', 'ciLowerLimit': '-0.568', 'ciUpperLimit': '0.135', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.179', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.363', 'ciLowerLimit': '-0.714', 'ciUpperLimit': '-0.012', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.179', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.246', 'ciLowerLimit': '-0.598', 'ciUpperLimit': '0.106', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.179', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.146', 'ciLowerLimit': '-0.503', 'ciUpperLimit': '0.210', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.182', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.029', 'ciLowerLimit': '-0.379', 'ciUpperLimit': '0.321', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.178', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.117', 'ciLowerLimit': '-0.235', 'ciUpperLimit': '0.470', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.180', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 and 4', 'description': 'Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol \\[albuterol\\] dose (100 mcg per puff).', 'unitOfMeasure': 'number of puffs per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Physicians Global Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '4.618', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '4.631', 'spread': '0.090', 'groupId': 'OG001'}, {'value': '4.484', 'spread': '0.089', 'groupId': 'OG002'}, {'value': '4.579', 'spread': '0.091', 'groupId': 'OG003'}, {'value': '4.747', 'spread': '0.090', 'groupId': 'OG004'}, {'value': '4.464', 'spread': '0.091', 'groupId': 'OG005'}, {'value': '4.634', 'spread': '0.090', 'groupId': 'OG006'}, {'value': '4.690', 'spread': '0.090', 'groupId': 'OG007'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '4.985', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '5.146', 'spread': '0.091', 'groupId': 'OG001'}, {'value': '5.248', 'spread': '0.091', 'groupId': 'OG002'}, {'value': '5.070', 'spread': '0.094', 'groupId': 'OG003'}, {'value': '5.109', 'spread': '0.092', 'groupId': 'OG004'}, {'value': '5.280', 'spread': '0.093', 'groupId': 'OG005'}, {'value': '5.165', 'spread': '0.092', 'groupId': 'OG006'}, {'value': '5.227', 'spread': '0.092', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.014', 'ciLowerLimit': '-0.223', 'ciUpperLimit': '0.250', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.121', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'groupDescription': 'Day 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.133', 'ciLowerLimit': '-0.370', 'ciUpperLimit': '0.104', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.121', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'groupDescription': 'Day 1', 'statisticalMethod': 'Mixed Models 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Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.056', 'ciLowerLimit': '-0.293', 'ciUpperLimit': '0.180', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.120', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'Day 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.169', 'ciLowerLimit': '-0.069', 'ciUpperLimit': '0.408', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.121', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'Day 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.226', 'ciLowerLimit': '-0.010', 'ciUpperLimit': '0.461', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.120', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'Day 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.057', 'ciLowerLimit': '-0.180', 'ciUpperLimit': '0.293', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.120', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'groupDescription': 'Day 1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.160', 'ciLowerLimit': '-0.067', 'ciUpperLimit': '0.387', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'estimateComment': 'Difference calculated as T+O 1.25/ minus Olo 5', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.262', 'ciLowerLimit': '0.034', 'ciUpperLimit': '0.491', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.084', 'ciLowerLimit': '-0.148', 'ciUpperLimit': '0.316', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.118', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.102', 'ciLowerLimit': '-0.124', 'ciUpperLimit': '0.328', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.115', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus T+O 1.25/5', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.076', 'ciLowerLimit': '-0.306', 'ciUpperLimit': '0.154', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.117', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 1.25/5', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.178', 'ciLowerLimit': '-0.408', 'ciUpperLimit': '0.052', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.117', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.172', 'ciLowerLimit': '-0.056', 'ciUpperLimit': '0.400', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.057', 'ciLowerLimit': '-0.171', 'ciUpperLimit': '0.285', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.118', 'ciLowerLimit': '-0.110', 'ciUpperLimit': '0.346', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.115', 'ciLowerLimit': '-0.345', 'ciUpperLimit': '0.115', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.117', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.054', 'ciLowerLimit': '-0.281', 'ciUpperLimit': '0.173', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.061', 'ciLowerLimit': '-0.166', 'ciUpperLimit': '0.289', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'groupDescription': 'Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 29', 'description': "Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29.\n\nThe score was evaluated on a 8-points scale :\n\n* Poor : 1,2\n* Fair : 3,4\n* Good : 5,6\n* Excellent : 7,8", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Patients Global Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral 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combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.357', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '3.135', 'spread': '0.102', 'groupId': 'OG001'}, {'value': '2.916', 'spread': '0.102', 'groupId': 'OG002'}, {'value': '3.208', 'spread': '0.104', 'groupId': 'OG003'}, {'value': '3.262', 'spread': '0.102', 'groupId': 'OG004'}, {'value': '2.880', 'spread': '0.103', 'groupId': 'OG005'}, {'value': '3.130', 'spread': '0.102', 'groupId': 'OG006'}, {'value': '2.936', 'spread': '0.102', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.222', 'ciLowerLimit': '-0.481', 'ciUpperLimit': '0.037', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'estimateComment': 'Difference calculated as T+O 1.25/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.441', 'ciLowerLimit': '-0.700', 'ciUpperLimit': '-0.182', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'estimateComment': 'Difference calculated as T+O 2.5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.149', 'ciLowerLimit': '-0.409', 'ciUpperLimit': '0.111', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.133', 'estimateComment': 'Difference calculated as T+O 5/5 minus Olo 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 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{'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.292', 'ciLowerLimit': '0.031', 'ciUpperLimit': '0.553', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.133', 'estimateComment': 'Difference calculated as T+O 5/5 minus T+O 2.5/5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.382', 'ciLowerLimit': '-0.641', 'ciUpperLimit': '-0.123', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'estimateComment': 'Difference calculated as T+O 1.25/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.132', 'ciLowerLimit': '-0.390', 'ciUpperLimit': '0.127', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.326', 'ciLowerLimit': '-0.585', 'ciUpperLimit': '-0.067', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'estimateComment': 'Difference calculated as T+O 5/10 minus Olo 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.250', 'ciLowerLimit': '-0.010', 'ciUpperLimit': '0.511', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.133', 'estimateComment': 'Difference calculated as T+O 2.5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.056', 'ciLowerLimit': '-0.202', 'ciUpperLimit': '0.314', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 1.25/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.194', 'ciLowerLimit': '-0.453', 'ciUpperLimit': '0.065', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'estimateComment': 'Difference calculated as T+O 5/10 minus T+O 2.5/10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': "Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29.\n\nThe score was evaluated on a 7-point scale :\n\n* 1 : very much better\n* 2 : much better\n* 3 : a little better\n* 4 : no change\n* 5 : a little worse\n* 6 : much worse\n* 7 : very much worse", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Pulse Rate Recorded in Conjunction With Spirometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '106', 'groupId': 'OG005'}, {'value': '108', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '10.3', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '9.5', 'groupId': 'OG003'}, {'value': '-2.1', 'spread': '8.5', 'groupId': 'OG004'}, {'value': '-3.6', 'spread': '9.6', 'groupId': 'OG005'}, {'value': '-2.4', 'spread': '10.5', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': '10.2', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 min post-dose on day 29', 'description': 'Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for pulse rate at baseline and day 29.'}, {'type': 'SECONDARY', 'title': 'Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '106', 'groupId': 'OG005'}, {'value': '108', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Olo 5', 'description': 'Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG001', 'title': 'T+O 1.25/5', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG002', 'title': 'T+O 2.5/5', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG003', 'title': 'T+O 5/5', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG004', 'title': 'Olo 10', 'description': 'Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.'}, {'id': 'OG005', 'title': 'T+O 1.25/10', 'description': 'Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG006', 'title': 'T+O 2.5/10', 'description': 'Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}, {'id': 'OG007', 'title': 'T+O 5/10', 'description': 'Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '-7.2', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '15.0', 'groupId': 'OG002'}, {'value': '-4.8', 'spread': '13.9', 'groupId': 'OG003'}, {'value': '-3.4', 'spread': '14.7', 'groupId': 'OG004'}, {'value': '-5.5', 'spread': '15.2', 'groupId': 'OG005'}, {'value': '-3.8', 'spread': '14.2', 'groupId': 'OG006'}, {'value': '-2.2', 'spread': '13.0', 'groupId': 'OG007'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '9.8', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '9.8', 'groupId': 'OG003'}, {'value': '-3.0', 'spread': '8.6', 'groupId': 'OG004'}, {'value': '-3.0', 'spread': '9.1', 'groupId': 'OG005'}, {'value': '-2.5', 'spread': '9.7', 'groupId': 'OG006'}, {'value': '-0.4', 'spread': '9.2', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 30 min post-dose on day 29', 'description': 'Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for systolic and diastolic blood pressure at baseline and day 29.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:\n\n* Olodaterol 5 µg and placebo\n* Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution\n* Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution\n* Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution\n* Olodaterol 10 µg and placebo\n* Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution\n* Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution\n* Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}]}, {'type': 'Completed Olo 5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'Completed T+O 1.25/5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}]}, {'type': 'Completed T+O 2.5/5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'Completed T+O 5/5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'Completed Olo 10', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'Completed T+O 1.25/10', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'Completed T+O 2.5/10', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'Completed T+O 5/10', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'All treatment periods', 'groupId': 'FG000', 'numSubjects': '213'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'This was a randomised, 4-period incomplete cross-over trial. 233 patients were randomized to one of 14 treatment sequences and 232 of them were treated. It was a double-blind trial in which each treatment period lasted 4 weeks with a washout period of 21 days between each.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:\n\n* Olodaterol 5 µg and placebo\n* Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution\n* Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution\n* Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution\n* Olodaterol 10 µg and placebo\n* Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution\n* Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution\n* Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '133', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS) which comprised all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'dispFirstSubmitDate': '2014-03-28', 'lastUpdateSubmitDate': '2015-06-19', 'studyFirstSubmitDate': '2009-12-28', 'dispFirstSubmitQcDate': '2014-03-28', 'resultsFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2009-12-28', 'dispFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-19', 'studyFirstPostDateStruct': {'date': '2009-12-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough FEV1 Response', 'timeFrame': 'Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29', 'description': 'Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Trough Forced Vital Capacity (FVC) Response', 'timeFrame': 'Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29', 'description': 'Adjusted means of trough FVC (forced vital capacity) response \\[L\\] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'FEV1 AUC 0-3h and FEV1 AUC 0-6h Response', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29', 'description': 'Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses \\[L\\] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'FEV1 AUC 0-3h Response After the First Dose', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1', 'description': 'Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response \\[L\\] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'FEV1 Peak 0-3h Response', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29', 'description': 'Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response \\[L\\] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'FEV1 Peak 0-3h Response After the First Dose', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1', 'description': 'Adjusted means of the FEV1 peak 0-3h response \\[L\\] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'FVC AUC 0-3h and FEV1 AUC 0-6h Responses', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29', 'description': 'Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses \\[L\\] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'FVC AUC 0-3h Response After First Dose', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1', 'description': 'Adjusted means of the FVC AUC 0-3h response \\[L\\] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'FVC Peak 0-3h Response', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29', 'description': 'Adjusted means of the FVC peak 0-3h response \\[L\\] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'FVC Peak 0-3h Response After the First Dose', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1', 'description': 'Adjusted mean of the FVC peak 0-3h response \\[L\\] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'PEF AUC 0-3h and AUC 0-6h Responses', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29', 'description': 'Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'PEF AUC 0-3h Response After the First Dose', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1', 'description': 'Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'PEF Peak 0-3h Response', 'timeFrame': 'Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29', 'description': 'Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'PEF Peak 0-3h Response After the First Dose', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1', 'description': 'Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'Individual FEV1 Measurements at Each Time Point on Day 29', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29', 'description': 'Adjusted means of the FEV1 measurements \\[L\\] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'Individual FVC Measurements at Each Time Point on Day 29', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29', 'description': 'Adjusted means of the FVC measurements \\[L\\] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'Individual PEF Measurements at Each Time Point on Day 29', 'timeFrame': 'Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29', 'description': 'Adjusted means of the PEF measurements \\[L/min\\] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.'}, {'measure': 'Weekly Mean Number of Puffs of Rescue Medication Used Per Day', 'timeFrame': 'Weeks 1 and 4', 'description': 'Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol \\[albuterol\\] dose (100 mcg per puff).'}, {'measure': 'Physicians Global Evaluation', 'timeFrame': 'Days 1 and 29', 'description': "Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29.\n\nThe score was evaluated on a 8-points scale :\n\n* Poor : 1,2\n* Fair : 3,4\n* Good : 5,6\n* Excellent : 7,8"}, {'measure': 'Patients Global Rating', 'timeFrame': 'Day 29', 'description': "Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29.\n\nThe score was evaluated on a 7-point scale :\n\n* 1 : very much better\n* 2 : much better\n* 3 : a little better\n* 4 : no change\n* 5 : a little worse\n* 6 : much worse\n* 7 : very much worse"}, {'measure': 'Pulse Rate Recorded in Conjunction With Spirometry', 'timeFrame': 'Baseline and 30 min post-dose on day 29', 'description': 'Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).'}, {'measure': 'Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry', 'timeFrame': 'Baseline and 30 min post-dose on day 29', 'description': 'Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '26404912', 'type': 'DERIVED', 'citation': 'Aalbers R, Maleki-Yazdi MR, Hamilton A, Waitere-Wijker S, Zhao Y, Amatto VC, Schmidt O, Bjermer L. Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat(R) Inhaler in Patients with Chronic Obstructive Pulmonary Disease. Adv Ther. 2015 Sep;32(9):809-22. doi: 10.1007/s12325-015-0239-8. Epub 2015 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. All patients must sign an informed consent\n2. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria:\n\na post-bronchodilator forced expiratory flow in 1 second (FEV1) =\\<30% of predicted normal and \\<80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) \\<70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years\n\nExclusion criteria:\n\n* Patients with a significant disease other than COPD;\n* Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;\n* Patients with a history of asthma or a total blood eosinophil count \\>=600/mm3.\n* Patients with any of the following conditions:\n\na diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years\n\n* Patients who have undergone thoracotomy with pulmonary resection\n* Patients being treated with the following concomitant medications:\n\nmedications that prolong the QT/QTc interval oral Beta-adrenergics oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day\n\n\\- Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT01040403', 'briefTitle': 'Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Double-blind, 8 Treatments, 4 Periods, Incomplete Crossover Study to Determine the Optimal Free Dose Combination of BI 1744 CL and Tiotropium Bromide (Both Delivered by the Respimat® Inhaler) After 4 Weeks Once Daily Treatment in Patients With COPD', 'orgStudyIdInfo': {'id': '1237.18'}, 'secondaryIdInfos': [{'id': '2009-014880-38', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'olodaterol (BI 1744) low and placebo', 'description': 'low dose inhaled olodaterol orally once daily from the Respimat inhaler', 'interventionNames': ['Drug: olodaterol (BI 1744) low', 'Drug: Placebo', 'Device: Respimat']}, {'type': 'EXPERIMENTAL', 'label': 'olodaterol (BI 1744) low and low tio', 'description': 'low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily', 'interventionNames': ['Drug: olodaterol (BI 1744) low', 'Drug: low tiotropium bromide', 'Device: Respimat']}, {'type': 'EXPERIMENTAL', 'label': 'olodaterol (BI 1744) low and medium tio', 'description': 'low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily', 'interventionNames': ['Drug: olodaterol (BI 1744) low', 'Drug: medium tiotropium bromide', 'Device: Respimat']}, {'type': 'EXPERIMENTAL', 'label': 'olodaterol (BI 1744) low and high tio', 'description': 'low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily', 'interventionNames': ['Drug: olodaterol (BI 1744) low', 'Drug: high tiotropium bromide', 'Device: Respimat']}, {'type': 'EXPERIMENTAL', 'label': 'olodaterol (BI 1744) high and placebo', 'description': 'high dose inhaled olodaterol orally once daily from the Respimat inhaler', 'interventionNames': ['Drug: olodaterol (BI 1744) high', 'Drug: Placebo', 'Device: Respimat']}, {'type': 'EXPERIMENTAL', 'label': 'Olodaterol (BI 1744) high and low tio', 'description': 'high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily', 'interventionNames': ['Drug: low tiotropium bromide', 'Drug: olodaterol (BI 1744) high', 'Device: Respimat']}, {'type': 'EXPERIMENTAL', 'label': 'Olodaterol (BI 1744) high and medium tio', 'description': 'high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily', 'interventionNames': ['Drug: olodaterol (BI 1744) high', 'Drug: medium tiotropium bromide', 'Device: Respimat']}, {'type': 'EXPERIMENTAL', 'label': 'Olodaterol (BI 1744) high and high tio', 'description': 'high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily', 'interventionNames': ['Drug: olodaterol (BI 1744) high', 'Drug: high tiotropium bromide', 'Device: Respimat']}], 'interventions': [{'name': 'olodaterol (BI 1744) low', 'type': 'DRUG', 'description': 'olodaterol (BI 1744) low', 'armGroupLabels': ['olodaterol (BI 1744) low and high tio', 'olodaterol (BI 1744) low and low tio', 'olodaterol (BI 1744) low and medium tio', 'olodaterol (BI 1744) low and placebo']}, {'name': 'low tiotropium bromide', 'type': 'DRUG', 'description': 'low tiotropium bromide', 'armGroupLabels': ['Olodaterol (BI 1744) high and low tio', 'olodaterol (BI 1744) low and low tio']}, {'name': 'olodaterol (BI 1744) high', 'type': 'DRUG', 'description': 'olodaterol (BI 1744) high', 'armGroupLabels': ['Olodaterol (BI 1744) high and high tio', 'Olodaterol (BI 1744) high and low tio', 'Olodaterol (BI 1744) high and medium tio', 'olodaterol (BI 1744) high and placebo']}, {'name': 'medium tiotropium bromide', 'type': 'DRUG', 'description': 'medium tiotropium bromide', 'armGroupLabels': ['Olodaterol (BI 1744) high and medium tio', 'olodaterol (BI 1744) low and medium tio']}, {'name': 'high tiotropium bromide', 'type': 'DRUG', 'description': 'high tiotropium bromide', 'armGroupLabels': ['Olodaterol (BI 1744) high and high tio', 'olodaterol (BI 1744) low and high tio']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['olodaterol (BI 1744) high and placebo', 'olodaterol (BI 1744) low and placebo']}, {'name': 'Respimat', 'type': 'DEVICE', 'description': 'Respimat inhaler', 'armGroupLabels': ['Olodaterol (BI 1744) high and high tio', 'Olodaterol (BI 1744) high and low tio', 'Olodaterol (BI 1744) high and medium tio', 'olodaterol (BI 1744) high and placebo', 'olodaterol (BI 1744) low and high tio', 'olodaterol (BI 1744) low and low tio', 'olodaterol (BI 1744) low and medium tio', 'olodaterol (BI 1744) low and placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': '1237.18.02004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Grimsby', 'state': 'Ontario', 'country': 'Canada', 'facility': '1237.18.02005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.20011, 'lon': -79.56631}}, {'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': '1237.18.02001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': '1237.18.02008 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 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