Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT01696058
Status:
COMPLETED
Last Update Posted:
2014-11-25
First Post:
2012-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®
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': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'C549647', 'term': 'olodaterol'}], '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 Pharmaceuticals'}, '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': 'Adverse events were to be documented throughout the trial, i.e., starting with informed consent and ending 21 days after last administration of trial medication. the duration of treatment was up to 12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning', 'otherNumAtRisk': 566, 'otherNumAffected': 48, 'seriousNumAtRisk': 566, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning', 'otherNumAtRisk': 569, 'otherNumAffected': 44, 'seriousNumAtRisk': 569, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 44}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Postoperative renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 569, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '0.297', 'spread': '0.010', 'groupId': 'OG000'}, {'value': '0.191', 'spread': '0.010', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.106', 'ciLowerLimit': '0.078', 'ciUpperLimit': '0.135', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.014', 'groupDescription': 'Results are from an mixed model repeated measure (MMRM) model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12. AUC was standardized by dividing by time unit.', 'unitOfMeasure': 'Area Under the Curve (L) (standardized)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables'}, {'type': 'PRIMARY', 'title': 'Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '0.175', 'spread': '0.009', 'groupId': 'OG000'}, {'value': '0.135', 'spread': '0.009', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.040', 'ciLowerLimit': '0.014', 'ciUpperLimit': '0.065', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.013', 'groupDescription': 'Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550).', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.'}, {'type': 'SECONDARY', 'title': 'Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1039', 'groupId': 'OG000'}, {'value': '1055', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '41.204', 'spread': '0.327', 'groupId': 'OG000'}, {'value': '43.059', 'spread': '0.325', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.854', 'ciLowerLimit': '-2.757', 'ciUpperLimit': '-0.951', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.461', 'groupDescription': 'Results are from ANCOVA model. Fixed effects include study, treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'The Saint George Respiratory Questionnaire (SGRQ) is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It is divided into two parts. Part I produces the Symptoms score (several scales), and Part II the Activity and Impacts scores \\[dichotomous (true/false) except last question (4-point Likert scale)\\]. A Total score is also produced with scores ranging from 0 to 100, with higher scores indicating more limitations. Since the SGRQ analysis is based on the combined data from both this study and protocol 1222.51 (NCT01694771), only combined SGRQ results will be included in the latest clinical trial report. Hence there will only be one SGRQ analysis from both studies, which will not appear in the first clinical trial report. For this same reason, another covariate - study - will also be included in the MMRM for SGRQ analysis. The combined data for this outcome measure was pre-specified in both protocols.', 'unitOfMeasure': 'units on a scale (total score)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with last observation carried forward (LOCF) imputation (combined data from twin studies 1222.51 and 1222.52). Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039).'}, {'type': 'SECONDARY', 'title': 'Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '0.371', 'spread': '0.011', 'groupId': 'OG000'}, {'value': '0.271', 'spread': '0.011', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.100', 'ciLowerLimit': '0.071', 'ciUpperLimit': '0.129', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.015', 'groupDescription': 'Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.\n\nNumber of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as change from baseline. All p-values for these measures are only descriptive.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.'}, {'type': 'SECONDARY', 'title': 'FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '0.424', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.306', 'spread': '0.017', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.118', 'ciLowerLimit': '0.072', 'ciUpperLimit': '0.164', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.023', 'groupDescription': 'Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.\n\nNumber of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 Weeks', 'description': 'Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline. AUC was standardized by dividing by time unit.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.'}, {'type': 'SECONDARY', 'title': 'Peak FVC Response at 12 Weeks; Defined as Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '0.562', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.457', 'spread': '0.017', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.104', 'ciLowerLimit': '0.057', 'ciUpperLimit': '0.152', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.\n\nNumber of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Peak FVC response at 12 weeks - defined as change from baseline.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.'}, {'type': 'SECONDARY', 'title': 'Trough FVC Response at 12 Weeks; Defined as Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '0.269', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.235', 'spread': '0.015', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1156', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.034', 'ciLowerLimit': '-0.008', 'ciUpperLimit': '0.076', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.022', 'groupDescription': 'Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.\n\nNumber of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550).', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last observation carried forward (LOCF) imputation'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Usage - Percentage of Rescue Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '552', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '53.207', 'spread': '1.481', 'groupId': 'OG000'}, {'value': '48.583', 'spread': '1.472', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '54.249', 'spread': '48.640', 'groupId': 'OG000'}, {'value': '48.640', 'spread': '1.477', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '54.820', 'spread': '1.536', 'groupId': 'OG000'}, {'value': '49.865', 'spread': '1.528', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '60.761', 'spread': '1.388', 'groupId': 'OG000'}, {'value': '55.969', 'spread': '1.378', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '60.154', 'spread': '1.550', 'groupId': 'OG000'}, {'value': '51.840', 'spread': '1.549', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '59.707', 'spread': '1.572', 'groupId': 'OG000'}, {'value': '49.001', 'spread': '1.568', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '59.493', 'spread': '1.598', 'groupId': 'OG000'}, {'value': '50.164', 'spread': '1.594', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '59.021', 'spread': '1.634', 'groupId': 'OG000'}, {'value': '51.017', 'spread': '1.626', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '60.524', 'spread': '1.636', 'groupId': 'OG000'}, {'value': '51.273', 'spread': '1.620', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '60.216', 'spread': '1.636', 'groupId': 'OG000'}, {'value': '51.634', 'spread': '1.616', 'groupId': 'OG001'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '59.650', 'spread': '1.636', 'groupId': 'OG000'}, {'value': '51.604', 'spread': '1.616', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '62.327', 'spread': '1.525', 'groupId': 'OG000'}, {'value': '55.090', 'spread': '1.508', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean difference from Tio+Placebo Week 12', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.237', 'ciLowerLimit': '3.028', 'ciUpperLimit': '11.446', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.145', 'groupDescription': 'Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 weeks', 'description': 'Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).\n\nResults are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last observation carried forward (LOCF) imputation'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '555', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.627', 'spread': '0.066', 'groupId': 'OG000'}, {'value': '2.072', 'spread': '0.066', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.652', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '2.145', 'spread': '0.072', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '1.635', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '2.167', 'spread': '0.078', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.647', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '2.189', 'spread': '0.080', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '1.551', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '2.183', 'spread': '0.080', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '1.523', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '2.179', 'spread': '0.080', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '1.540', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '2.138', 'spread': '0.082', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.586', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '2.107', 'spread': '0.084', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '1.519', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '2.121', 'spread': '0.082', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '1.499', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '2.103', 'spread': '0.081', 'groupId': 'OG001'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '1.484', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '2.107', 'spread': '0.082', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.535', 'spread': '0.084', 'groupId': 'OG000'}, {'value': '2.103', 'spread': '0.083', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean difference from Tio+Placebo Week 12', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.568', 'ciLowerLimit': '-0.800', 'ciUpperLimit': '-0.336', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.118', 'groupDescription': 'Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 weeks', 'description': 'Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol metered dose inhaler (MDI) (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.\n\nResults are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)', 'unitOfMeasure': 'usage (total daily) number of puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last observation carried forward (LOCF) imputation'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '555', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.406', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '0.437', 'spread': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.421', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '0.466', 'spread': '0.027', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0.407', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '0.459', 'spread': '0.030', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.408', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.479', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '0.375', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '0.479', 'spread': '0.030', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '0.378', 'spread': '0.030', 'groupId': 'OG000'}, {'value': '0.491', 'spread': '0.030', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '0.403', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '0.499', 'spread': '0.032', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.417', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '0.482', 'spread': '0.033', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '0.396', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '0.487', 'spread': '0.032', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '0.392', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '0.480', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '0.383', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.482', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.393', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '0.483', 'spread': '0.032', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0467', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean difference from Tio+Placebo Week 1', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.090', 'ciLowerLimit': '-0.178', 'ciUpperLimit': '-0.001', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.045', 'groupDescription': 'Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 weeks', 'description': 'Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.\n\nResults are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)', 'unitOfMeasure': 'number of puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last observation carried forward (LOCF) imputation'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '555', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose, 2 inhalations once daily in the morning\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning'}, {'id': 'OG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.222', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '1.633', 'spread': '0.055', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.232', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '1.677', 'spread': '0.058', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '1.229', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '1.707', 'spread': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.239', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '1.709', 'spread': '0.064', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '1.177', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '1.710', 'spread': '0.064', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '1.148', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '1.692', 'spread': '0.064', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '1.139', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '1.641', 'spread': '0.064', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.173', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '1.628', 'spread': '0.066', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '1.125', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '1.636', 'spread': '0.065', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '1.108', 'spread': '0.066', 'groupId': 'OG000'}, {'value': '1.630', 'spread': '0.065', 'groupId': 'OG001'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '1.104', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '1.630', 'spread': '0.066', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.143', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '1.625', 'spread': '0.066', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean difference from Tio+Placebo Week 12', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.483', 'ciLowerLimit': '-0.668', 'ciUpperLimit': '-0.298', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 weeks', 'description': 'Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.\n\nResults are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)', 'unitOfMeasure': 'number of puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last observation carried forward (LOCF) imputation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose\n\nTiotropium: Marketed dose'}, {'id': 'FG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '566'}, {'groupId': 'FG001', 'numSubjects': '569'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '523'}, {'groupId': 'FG001', 'numSubjects': '538'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Other reason prematurely discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '1137 patients were entered and randomized to treatment and 1135 patients were treated with study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'BG000'}, {'value': '569', 'groupId': 'BG001'}, {'value': '1135', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olodaterol (5μg) and Tiotropium (18μg)', 'description': '2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nOlodaterol: One dose\n\nTiotropium: Marketed dose'}, {'id': 'BG001', 'title': 'Placebo and Tiotropium (18μg)', 'description': '2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered\n\nTiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning\n\nPlacebo matching Olodaterol: One dose, 2 inhalations once daily in the morning'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '527', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '608', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS), which includes all randomized patients who receive at least one dose of double-blind study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2012-09-26', 'resultsFirstSubmitDate': '2014-09-05', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-05', 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12', 'timeFrame': 'baseline and 12 weeks', 'description': 'FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12. AUC was standardized by dividing by time unit.'}, {'measure': 'Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12', 'timeFrame': 'baseline and 12 weeks', 'description': 'Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data', 'timeFrame': '12 weeks', 'description': 'The Saint George Respiratory Questionnaire (SGRQ) is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It is divided into two parts. Part I produces the Symptoms score (several scales), and Part II the Activity and Impacts scores \\[dichotomous (true/false) except last question (4-point Likert scale)\\]. A Total score is also produced with scores ranging from 0 to 100, with higher scores indicating more limitations. Since the SGRQ analysis is based on the combined data from both this study and protocol 1222.51 (NCT01694771), only combined SGRQ results will be included in the latest clinical trial report. Hence there will only be one SGRQ analysis from both studies, which will not appear in the first clinical trial report. For this same reason, another covariate - study - will also be included in the MMRM for SGRQ analysis. The combined data for this outcome measure was pre-specified in both protocols.'}, {'measure': 'Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline', 'timeFrame': 'baseline and 12 weeks', 'description': 'Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as change from baseline. All p-values for these measures are only descriptive.'}, {'measure': 'FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline', 'timeFrame': 'baseline and 12 Weeks', 'description': 'Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline. AUC was standardized by dividing by time unit.'}, {'measure': 'Peak FVC Response at 12 Weeks; Defined as Change From Baseline', 'timeFrame': 'baseline and 12 weeks', 'description': 'Peak FVC response at 12 weeks - defined as change from baseline.'}, {'measure': 'Trough FVC Response at 12 Weeks; Defined as Change From Baseline', 'timeFrame': 'baseline and 12 weeks', 'description': 'Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.'}, {'measure': 'Rescue Medication Usage - Percentage of Rescue Free Days', 'timeFrame': 'over 12 weeks', 'description': 'Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).\n\nResults are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)'}, {'measure': 'Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)', 'timeFrame': 'over 12 weeks', 'description': 'Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol metered dose inhaler (MDI) (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.\n\nResults are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)'}, {'measure': 'Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)', 'timeFrame': 'over 12 weeks', 'description': 'Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.\n\nResults are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)'}, {'measure': 'Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)', 'timeFrame': 'over 12 weeks', 'description': 'Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.\n\nResults are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.\n\nNumber of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '25342898', 'type': 'DERIVED', 'citation': 'ZuWallack R, Allen L, Hernandez G, Ting N, Abrahams R. Efficacy and safety of combining olodaterol Respimat((R)) and tiotropium HandiHaler((R)) in patients with COPD: results of two randomized, double-blind, active-controlled studies. Int J Chron Obstruct Pulmon Dis. 2014 Oct 14;9:1133-44. doi: 10.2147/COPD.S72482. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function 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 consistent with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.\n2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have a relatively stable airway obstruction with a post-bronchodilator FEV1 ≥ 30 % and \\< 80% of predicted normal and a post-bronchodilator FEV1/FVC \\<70% at Visit 1.\n3. Male or female patients, 40 years of age or older.\n4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years\n5. Patients must be able to: perform technically acceptable pulmonary function tests, and maintain records(paper diary).\n6. Patients must be able to inhale medication in a competent manner from the Respimat Inhaler as well as the Handihaler.\n\nExclusion criteria:\n\n1. Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patients ability to participate in the study.\n2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an AST \\>x2 ULN, ALT \\>x2 ULN, bilirubin \\>x2 ULN or creatinine \\>x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients).\n3. Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count ≥600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.\n4. A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists).\n5. A diagnosis of paroxysmal tachycardia (\\>100 beats per minute) (due to the known class side effect profile of ß2-agonists).\n6. A history of myocardial infarction within 1 year of screening visit (Visit 1).\n7. Unstable or life-threatening cardiac arrhythmia.\n8. Hospitalization for heart failure within the past year.\n9. Known active tuberculosis.\n10. A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed).\n11. A history of life-threatening pulmonary obstruction.\n12. A history of cystic fibrosis.\n13. Clinically evident bronchiectasis.\n14. A history of significant alcohol or drug abuse.\n15. Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1).\n16. Patients being treated with oral or patch ß-adrenergics.\n17. Patients being treated with 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.\n18. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators opinion will be unable to abstain from the use of oxygen therapy during clinic visits.\n19. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program.\n20. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1).\n21. Patients with known hypersensitivity to ß-adrenergic drugs, BAC, EDTA, or any other component of the Respimat® inhalation solution.\n22. Patients with known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler®.\n23. Pregnant or nursing women.\n24. Women of childbearing potential not using a highly effective method of birth control\\*. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.\n\n \\* as per ICH M3(R2) a highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year).\n25. Patients who have previously been randomised in this study or are currently participating in another study.\n26. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation.'}, 'identificationModule': {'nctId': 'NCT01696058', 'briefTitle': 'Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Double Blind, Parallel Group Study to Assess the Efficacy and Safety of 12 Weeks of Once Daily, Orally Inhaled, Co-administration of Olodaterol 5µg (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) Compared to Once Daily, Orally Inhaled, Co-administration of Placebo (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) in Patients With Chronic Obstructive Pulmonary Disease (COPD)[ANHELTO TM 2]', 'orgStudyIdInfo': {'id': '1222.52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olodaterol andTiotropium', 'description': '2 puffs Olodaterol from 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