Viewing Study NCT02603393

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Ignite Creation Date: 2025-12-25 @ 1:23 AM
Ignite Modification Date: 2026-04-08 @ 12:13 PM
Study NCT ID: NCT02603393
Status: COMPLETED
Last Update Posted: 2019-04-29
First Post: 2015-09-17
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'C554862', 'term': 'indacaterol-glycopyrronium combination'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}], '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'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The study consists of four epochs: screening (1 week), run-in (4 weeks), blinded treatment (26 weeks) and follow-up (4 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation', 'otherNumAtRisk': 527, 'deathsNumAtRisk': 527, 'otherNumAffected': 398, 'seriousNumAtRisk': 527, 'deathsNumAffected': 4, 'seriousNumAffected': 32}, {'id': 'EG001', 'title': 'Tio+Salm/Flut', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)', 'otherNumAtRisk': 526, 'deathsNumAtRisk': 526, 'otherNumAffected': 392, 'seriousNumAtRisk': 526, 'deathsNumAffected': 5, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oropharyngeal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 370}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 353}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ophthalmic herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cholesteatoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Post-dose Trough FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.029', 'spread': '0.0119', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.0115', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0404', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.026', 'ciLowerLimit': '-0.053', 'ciUpperLimit': '0.001', 'pValueComment': '1 sided', 'statisticalMethod': 'Mixed Model for Repeated Measures Analys', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority will be demonstrated if the 95% confidence interval of the treatment difference lies entirely to the right of (higher than) -50 mL.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Mean change from baseline in post-dose trough forced expiratory volume in 1 second (FEV1) following 26 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values measured at 23 hr 15 min and 23 hr 45 min after the morning dose taken at site on Day 181. Baseline FEV1 is defined as the average of the pre-dose FEV1 measured at -45 min and -15 min at Day 1.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Moderate or Severe COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.63'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.40', 'upperLimit': '0.58'}]}]}], 'analyses': [{'pValue': '0.5802', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of rates', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.40', 'pValueComment': '2 sided', 'statisticalMethod': 'Generalized Linear Model Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Moderate or severe COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event.', 'unitOfMeasure': 'COPD exacerbations/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '0.58'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.53'}]}]}], 'analyses': [{'pValue': '0.5651', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.43', 'pValueComment': '2-sided', 'statisticalMethod': 'Generalized Linear Model Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event', 'unitOfMeasure': 'COPD Exacerbations/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of COPD Exacerbations Requiring Hospitalisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.001', 'comment': 'NA - Not estimable No patient in either treatment group had an event', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': 'NA'}, {'value': '0.001', 'comment': 'NA - Not estimable No patient in either treatment group had an event', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9665', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.44', 'ciUpperLimit': '2.34', 'pValueComment': '2-sided', 'statisticalMethod': 'Generalized Linear Model Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event.', 'unitOfMeasure': 'COPD Exacerbations/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Pre-dose Trough FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.029', 'spread': '0.0119', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.0115', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0573', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.026', 'ciLowerLimit': '-0.053', 'ciUpperLimit': '0.001', 'pValueComment': '2-Sided', 'statisticalMethod': 'Mixed Model for Repeated Measures Analys', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': 'Trough FEV1 is defined as the average of the pre-dose FEV1 measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FEV1 measurements at 23h15min and 23h45min after dosing at Day 181. Baseline FEV1 is considered the Day 1 average of pre-dose measurements.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in St. George's Respiratory Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '0.7', 'ciUpperLimit': '3.0', 'pValueComment': '2-Sided', 'statisticalMethod': 'Mixed Model for Repeated Measures Analys', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in St. George's Respiratory Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.2', 'ciUpperLimit': '2.6', 'pValueComment': '2-Sided', 'statisticalMethod': 'Mixed Model for Repeated measures Analys', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': 'The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Transition Dyspnea Index (TDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.177', 'spread': '0.1558', 'groupId': 'OG000'}, {'value': '1.418', 'spread': '0.1508', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1724', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.241', 'ciLowerLimit': '-0.587', 'ciUpperLimit': '0.105', 'statisticalMethod': 'Mixed Model for Repeated Measures Analys', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': "Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Transition Dyspnea Index (TDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.382', 'spread': '0.1567', 'groupId': 'OG000'}, {'value': '1.671', 'spread': '0.1519', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.288', 'ciLowerLimit': '-0.638', 'ciUpperLimit': '0.061', 'pValueComment': '2-Sided', 'statisticalMethod': 'Mixed Model for Repated Measures Analysi', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '26 weeks', 'description': "Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.307', 'spread': '0.1006', 'groupId': 'OG000'}, {'value': '-0.484', 'spread': '0.0983', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0641', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.177', 'ciLowerLimit': '-0.010', 'ciUpperLimit': '0.365', 'pValueComment': '2-Sided', 'statisticalMethod': 'Linear Mixed Model Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Change from baseline in mean daily number of puffs of rescue medication (number of puffs taken in the previous 12 hours) over 26 weeks of treatment.', 'unitOfMeasure': 'Number of puffs per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'OG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.0192', 'groupId': 'OG000'}, {'value': '-0.048', 'spread': '0.0186', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.018', 'ciLowerLimit': '-0.025', 'ciUpperLimit': '0.061', 'pValueComment': '2-Sided', 'statisticalMethod': 'Mixed Model for Repeated Measures Analys', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Change from baseline in forced vital capacity following 26 weeks of treatment. Trough FVC is defined as the average of the pre-dose FVC measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FVC measurements at 23h15min and 23h45min after dosing at Day 181. Baseline is considered the Day 1 average of pre-dose measurements.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'FG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '526'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '456'}, {'groupId': 'FG001', 'numSubjects': '472'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Patient/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'BG000'}, {'value': '526', 'groupId': 'BG001'}, {'value': '1053', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'QVA149', 'description': '110/50 μg capsules o.d. for inhalation'}, {'id': 'BG001', 'title': 'Tiotropium + Salmeterol/Fluticasone', 'description': 'tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '7.99', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '7.62', 'groupId': 'BG001'}, {'value': '65.3', 'spread': '7.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '378', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '743', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '526', 'groupId': 'BG000'}, {'value': '523', 'groupId': 'BG001'}, {'value': '1049', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-18', 'size': 472284, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-09T10:14', 'hasProtocol': False}, {'date': '2017-08-09', 'size': 20885215, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-09T10:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1053}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2015-09-17', 'resultsFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-25', 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Post-dose Trough FEV1', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Mean change from baseline in post-dose trough forced expiratory volume in 1 second (FEV1) following 26 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values measured at 23 hr 15 min and 23 hr 45 min after the morning dose taken at site on Day 181. Baseline FEV1 is defined as the average of the pre-dose FEV1 measured at -45 min and -15 min at Day 1.'}], 'secondaryOutcomes': [{'measure': 'Annualized Rate of Moderate or Severe COPD Exacerbations', 'timeFrame': '26 weeks', 'description': 'Moderate or severe COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event.'}, {'measure': 'Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only', 'timeFrame': '26 weeks', 'description': 'COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event'}, {'measure': 'Annualized Rate of COPD Exacerbations Requiring Hospitalisation', 'timeFrame': '26 weeks', 'description': 'COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event.'}, {'measure': 'Mean Change From Baseline in Pre-dose Trough FEV1', 'timeFrame': '26 weeks', 'description': 'Trough FEV1 is defined as the average of the pre-dose FEV1 measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FEV1 measurements at 23h15min and 23h45min after dosing at Day 181. Baseline FEV1 is considered the Day 1 average of pre-dose measurements.'}, {'measure': "Mean Change From Baseline in St. George's Respiratory Questionnaire", 'timeFrame': 'Baseline, 12 weeks', 'description': 'The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.'}, {'measure': "Mean Change From Baseline in St. George's Respiratory Questionnaire", 'timeFrame': 'Baseline, 26 weeks', 'description': 'The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.'}, {'measure': 'Transition Dyspnea Index (TDI) Score', 'timeFrame': '12 weeks', 'description': "Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline."}, {'measure': 'Transition Dyspnea Index (TDI) Score', 'timeFrame': '26 weeks', 'description': "Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline."}, {'measure': 'Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Change from baseline in mean daily number of puffs of rescue medication (number of puffs taken in the previous 12 hours) over 26 weeks of treatment.'}, {'measure': 'Mean Change From Baseline in Forced Vital Capacity (FVC)', 'timeFrame': 'Baseline, 26 weeks', 'description': 'Change from baseline in forced vital capacity following 26 weeks of treatment. Trough FVC is defined as the average of the pre-dose FVC measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FVC measurements at 23h15min and 23h45min after dosing at Day 181. Baseline is considered the Day 1 average of pre-dose measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD, QVA149'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '29779416', 'type': 'DERIVED', 'citation': 'Chapman KR, Hurst JR, Frent SM, Larbig M, Fogel R, Guerin T, Banerji D, Patalano F, Goyal P, Pfister P, Kostikas K, Wedzicha JA. Long-Term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in Patients with Chronic Obstructive Pulmonary Disease (SUNSET): A Randomized, Double-Blind, Triple-Dummy Clinical Trial. Am J Respir Crit Care Med. 2018 Aug 1;198(3):329-339. doi: 10.1164/rccm.201803-0405OC.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.\n* Male and female adults aged ≥ 40 years.\n* Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines.\n* Patients with a post-bronchodilator FEV1 ≥40 and \\< 80% of the predicted normal value, and post-bronchodilator FEV1/FVC \\< 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 µg of salbutamol).\n* Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at screening.\n* Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).\n\nExclusion Criteria:\n\n* Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) .\n* Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.\n* Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT02603393', 'briefTitle': 'Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 26-week, Randomized, Double Blind, Parallel-group Multicenter Study to Assess the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD', 'orgStudyIdInfo': {'id': 'CQVA149A2316'}, 'secondaryIdInfos': [{'id': '2015-000114-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QVA149', 'interventionNames': ['Drug: QVA149']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tiotropium + salmeterol/fluticasone', 'interventionNames': ['Drug: Tiotropium', 'Drug: Salmeterol/fluticasone']}], 'interventions': [{'name': 'QVA149', 'type': 'DRUG', 'description': 'QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI', 'armGroupLabels': ['QVA149']}, {'name': 'Tiotropium', 'type': 'DRUG', 'description': 'Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®', 'armGroupLabels': ['Tiotropium + salmeterol/fluticasone']}, {'name': 'Salmeterol/fluticasone', 'type': 'DRUG', 'description': 'Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™', 'armGroupLabels': ['Tiotropium + salmeterol/fluticasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1425BEN', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'B8000XAV', 'city': 'Lanús', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.70757, 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