Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-01 @ 1:10 PM
Study NCT ID:
NCT02006732
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2013-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ukraine']}, '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'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Other - 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': 'up to 112 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat', 'otherNumAtRisk': 202, 'otherNumAffected': 34, 'seriousNumAtRisk': 202, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat', 'otherNumAtRisk': 203, 'otherNumAffected': 15, 'seriousNumAtRisk': 203, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Tiotropium 2.5 μg +Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.', 'otherNumAtRisk': 202, 'otherNumAffected': 25, 'seriousNumAtRisk': 202, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Tiotropium 5 μg +Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.', 'otherNumAtRisk': 202, 'otherNumAffected': 14, 'seriousNumAtRisk': 202, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FEV1 AUC0-3h Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'OG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'OG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'OG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.188', 'spread': '0.013', 'groupId': 'OG001'}, {'value': '0.279', 'spread': '0.014', 'groupId': 'OG002'}, {'value': '0.293', 'spread': '0.013', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.299', 'ciLowerLimit': '0.261', 'ciUpperLimit': '0.336', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.105', 'ciLowerLimit': '0.069', 'ciUpperLimit': '0.141', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.284', 'ciLowerLimit': '0.246', 'ciUpperLimit': '0.323', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.091', 'ciLowerLimit': '0.053', 'ciUpperLimit': '0.128', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.194', 'ciLowerLimit': '0.156', 'ciUpperLimit': '0.232', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4499', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.014', 'ciLowerLimit': '-0.023', 'ciUpperLimit': '0.051', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints.'}, {'type': 'PRIMARY', 'title': 'Trough FEV1 Response (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '199', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'OG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'OG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'OG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.124', 'spread': '0.013', 'groupId': 'OG001'}, {'value': '0.166', 'spread': '0.013', 'groupId': 'OG002'}, {'value': '0.163', 'spread': '0.013', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.166', 'ciLowerLimit': '0.129', 'ciUpperLimit': '0.203', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0395', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.039', 'ciLowerLimit': '0.002', 'ciUpperLimit': '0.076', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.169', 'ciLowerLimit': '0.132', 'ciUpperLimit': '0.207', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0269', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.042', 'ciLowerLimit': '0.005', 'ciUpperLimit': '0.079', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.127', 'ciLowerLimit': '0.090', 'ciUpperLimit': '0.165', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8669', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.003', 'ciLowerLimit': '-0.040', 'ciUpperLimit': '0.034', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.019', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS'}, {'type': 'PRIMARY', 'title': "St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study", 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}, {'value': '197', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'OG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'OG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'OG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.575', 'spread': '0.711', 'groupId': 'OG000'}, {'value': '39.729', 'spread': '0.694', 'groupId': 'OG001'}, {'value': '38.909', 'spread': '0.691', 'groupId': 'OG002'}, {'value': '38.011', 'spread': '0.683', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.564', 'ciLowerLimit': '-6.499', 'ciUpperLimit': '-2.629', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.986', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0780', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.717', 'ciLowerLimit': '-3.628', 'ciUpperLimit': '0.193', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.974', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.666', 'ciLowerLimit': '-5.611', 'ciUpperLimit': '-1.721', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.991', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4028', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.820', 'ciLowerLimit': '-2.741', 'ciUpperLimit': '1.102', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.979', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.846', 'ciLowerLimit': '-4.796', 'ciUpperLimit': '-0.897', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.993', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3555', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.898', 'ciLowerLimit': '-2.804', 'ciUpperLimit': '1.008', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.971', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks treatment', 'description': 'The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).\n\nThe adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS'}, {'type': 'PRIMARY', 'title': "St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352", 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}, {'value': '394', 'groupId': 'OG002'}, {'value': '393', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'OG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'OG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'OG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.265', 'spread': '0.511', 'groupId': 'OG000'}, {'value': '39.694', 'spread': '0.498', 'groupId': 'OG001'}, {'value': '38.419', 'spread': '0.494', 'groupId': 'OG002'}, {'value': '37.597', 'spread': '0.492', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.668', 'ciLowerLimit': '-6.060', 'ciUpperLimit': '-3.276', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.710', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0028', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.097', 'ciLowerLimit': '-3.471', 'ciUpperLimit': '-0.723', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.701', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.846', 'ciLowerLimit': '-5.240', 'ciUpperLimit': '-2.451', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.711', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0696', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.274', 'ciLowerLimit': '-2.651', 'ciUpperLimit': '0.102', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.702', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.571', 'ciLowerLimit': '-3.971', 'ciUpperLimit': '-1.171', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.714', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2387', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.822', 'ciLowerLimit': '-2.191', 'ciUpperLimit': '0.546', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.698', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks treatment', 'description': 'This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).\n\nThe adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS after combining the data from this and the replicate study NCT01964352'}, {'type': 'SECONDARY', 'title': 'Trough Forced Vital Capacity (FVC) Response (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '199', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'OG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'OG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'OG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.170', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.284', 'spread': '0.023', 'groupId': 'OG002'}, {'value': '0.231', 'spread': '0.023', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.252', 'ciLowerLimit': '0.187', 'ciUpperLimit': '0.317', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0614', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.061', 'ciLowerLimit': '-0.003', 'ciUpperLimit': '0.125', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.305', 'ciLowerLimit': '0.240', 'ciUpperLimit': '0.370', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.114', 'ciLowerLimit': '0.049', 'ciUpperLimit': '0.178', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.191', 'ciLowerLimit': '0.126', 'ciUpperLimit': '0.256', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1089', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.053', 'ciLowerLimit': '-0.117', 'ciUpperLimit': '0.012', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS'}, {'type': 'SECONDARY', 'title': 'TDI Focal Score Based on Data From This Individual Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}, {'value': '197', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'OG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'OG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'OG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.337', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '0.950', 'spread': '0.191', 'groupId': 'OG001'}, {'value': '1.599', 'spread': '0.189', 'groupId': 'OG002'}, {'value': '1.531', 'spread': '0.187', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.195', 'ciLowerLimit': '0.665', 'ciUpperLimit': '1.725', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.270', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0296', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.582', 'ciLowerLimit': '0.058', 'ciUpperLimit': '1.106', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.267', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.263', 'ciLowerLimit': '0.730', 'ciUpperLimit': '1.796', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.272', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0159', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.650', 'ciLowerLimit': '0.122', 'ciUpperLimit': '1.178', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.269', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.613', 'ciLowerLimit': '0.078', 'ciUpperLimit': '1.148', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.273', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7984', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.068', 'ciLowerLimit': '-0.590', 'ciUpperLimit': '0.454', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.266', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).\n\nThe adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS'}, {'type': 'SECONDARY', 'title': 'TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '394', 'groupId': 'OG002'}, {'value': '393', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'OG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'OG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'OG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.111', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '1.140', 'spread': '0.136', 'groupId': 'OG001'}, {'value': '1.722', 'spread': '0.134', 'groupId': 'OG002'}, {'value': '1.734', 'spread': '0.134', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.623', 'ciLowerLimit': '1.245', 'ciUpperLimit': '2.000', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.193', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0019', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.594', 'ciLowerLimit': '0.220', 'ciUpperLimit': '0.967', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.190', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.611', 'ciLowerLimit': '1.232', 'ciUpperLimit': '1.989', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.193', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0023', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.582', 'ciLowerLimit': '0.207', 'ciUpperLimit': '0.956', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.191', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.029', 'ciLowerLimit': '0.649', 'ciUpperLimit': '1.410', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.194', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9494', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.012', 'ciLowerLimit': '-0.359', 'ciUpperLimit': '0.383', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.189', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).\n\nThe adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS after combining the data from this and the replicate study NCT01964352'}, {'type': 'SECONDARY', 'title': 'FVC AUC0-3h Response (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'OG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'OG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'OG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.018', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '0.266', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.436', 'spread': '0.024', 'groupId': 'OG002'}, {'value': '0.414', 'spread': '0.023', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.432', 'ciLowerLimit': '0.366', 'ciUpperLimit': '0.498', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.148', 'ciLowerLimit': '0.084', 'ciUpperLimit': '0.212', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.455', 'ciLowerLimit': '0.387', 'ciUpperLimit': '0.522', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.034', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.171', 'ciLowerLimit': '0.105', 'ciUpperLimit': '0.236', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.034', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.284', 'ciLowerLimit': '0.217', 'ciUpperLimit': '0.350', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.034', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4974', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.022', 'ciLowerLimit': '-0.087', 'ciUpperLimit': '0.042', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'FG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'FG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'FG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '203'}, {'groupId': 'FG002', 'numSubjects': '202'}, {'groupId': 'FG003', 'numSubjects': '202'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '191'}, {'groupId': 'FG002', 'numSubjects': '193'}, {'groupId': 'FG003', 'numSubjects': '198'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '809 patients were randomised and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}, {'value': '809', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Once daily 2 puffs solution of placebo for inhalation with Respimat'}, {'id': 'BG001', 'title': 'Tiotropium 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat'}, {'id': 'BG002', 'title': 'Tiotropium 2.5 μg+ Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'BG003', 'title': 'Tiotropium 5 μg + Olodaterol 5 μg', 'description': 'Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '8.6', 'groupId': 'BG002'}, {'value': '65.2', 'spread': '8.5', 'groupId': 'BG003'}, {'value': '64.6', 'spread': '8.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '303', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}, {'value': '506', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 809}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2013-10-14', 'resultsFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-10', 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1 AUC0-3h Response', 'timeFrame': 'baseline and 12 weeks', 'description': 'Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.'}, {'measure': 'Trough FEV1 Response (Change From Baseline)', 'timeFrame': 'baseline and 12 weeks', 'description': 'Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.'}, {'measure': "St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study", 'timeFrame': '12 weeks treatment', 'description': 'The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).\n\nThe adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.'}, {'measure': "St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352", 'timeFrame': '12 weeks treatment', 'description': 'This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).\n\nThe adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.'}], 'secondaryOutcomes': [{'measure': 'Trough Forced Vital Capacity (FVC) Response (Change From Baseline)', 'timeFrame': 'baseline and 12 weeks', 'description': 'Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.'}, {'measure': 'TDI Focal Score Based on Data From This Individual Study', 'timeFrame': '12 weeks', 'description': "Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).\n\nThe adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom."}, {'measure': 'TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352', 'timeFrame': '12 weeks', 'description': "This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).\n\nThe adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom."}, {'measure': 'FVC AUC0-3h Response (Change From Baseline)', 'timeFrame': 'baseline and 12 weeks', 'description': 'The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '32671684', 'type': 'DERIVED', 'citation': 'Buhl R, de la Hoz A, Xue W, Singh D, Ferguson GT. Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naive to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials. Adv Ther. 2020 Oct;37(10):4175-4189. doi: 10.1007/s12325-020-01411-0. Epub 2020 Jul 15.'}, {'pmid': '32462607', 'type': 'DERIVED', 'citation': 'Buhl R, Singh D, de la Hoz A, Xue W, Ferguson GT. Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO(R) and OTEMTO(R) Studies. Adv Ther. 2020 Aug;37(8):3485-3499. doi: 10.1007/s12325-020-01373-3. Epub 2020 May 27.'}, {'pmid': '27316465', 'type': 'DERIVED', 'citation': 'Singh D, Gaga M, Schmidt O, Bjermer L, Gronke L, Voss F, Ferguson GT. Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO(R) studies. Respir Res. 2016 Jun 18;17(1):73. doi: 10.1186/s12931-016-0387-7.'}, {'pmid': '26320402', 'type': 'DERIVED', 'citation': 'Singh D, Ferguson GT, Bolitschek J, Gronke L, Hallmann C, Bennett N, Abrahams R, Schmidt O, Bjermer L. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015 Oct;109(10):1312-9. doi: 10.1016/j.rmed.2015.08.002. Epub 2015 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis chronic obstructive pulmonary disease\n* Relatively stable airway obstruction with post FEV1 \\>=30 and \\< 80% predicted normal and post FEV1/ FVC \\< 70%\n* Male or female patients, 40 years of age or more\n* Smoking history more than 10 pack years\n\nExclusion criteria:\n\n* Significant diseases other than COPD\n* History of asthma\n* COPD exacerbation in previous 3 months\n* Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.\n* Pregnant or nursing women\n* Patients unable to comply with pulmonary medication restrictions'}, 'identificationModule': {'nctId': 'NCT02006732', 'briefTitle': 'Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium+ Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '1237.26'}, 'secondaryIdInfos': [{'id': '2013-002264-24', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tiotropium + olodaterol low dose', 'description': 'Once daily 2 puffs solution for 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