Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-03 @ 4:29 AM
Study NCT ID:
NCT02125734
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients
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': 'C554862', 'term': 'indacaterol-glycopyrronium combination'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': {'eventGroups': [{'id': 'EG000', 'title': 'QVA149', 'description': 'QVA149', 'otherNumAtRisk': 88, 'otherNumAffected': 28, 'seriousNumAtRisk': 88, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Tiotropium', 'description': 'Tiotropium', 'otherNumAtRisk': 88, 'otherNumAffected': 21, 'seriousNumAtRisk': 88, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Escherichia test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Hypotonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Renal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Increased viscosity of bronchial secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}], 'seriousEvents': [{'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149'}, {'id': 'OG001', 'title': 'Tiotropium'}], 'classes': [{'categories': [{'measurements': [{'value': '1.676', 'spread': '0.5709', 'groupId': 'OG000', 'lowerLimit': '1.635', 'upperLimit': '1.716'}, {'value': '1.595', 'spread': '0.6000', 'groupId': 'OG001', 'lowerLimit': '1.555', 'upperLimit': '1.634'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.081', 'ciLowerLimit': '0.031', 'ciUpperLimit': '0.130', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 4', 'description': 'Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period'}, {'type': 'SECONDARY', 'title': 'Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149'}, {'id': 'OG001', 'title': 'Tiotropium'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': "Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Three patients were missing data for the patient preference analysis.'}, {'type': 'SECONDARY', 'title': 'Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149'}, {'id': 'OG001', 'title': 'Tiotropium'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. One patient with missing data for this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence 1', 'description': 'QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56'}, {'id': 'FG001', 'title': 'Treatment Sequence 2', 'description': 'Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Sequence 1', 'description': 'QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56'}, {'id': 'BG001', 'title': 'Treatment Sequence 2', 'description': 'Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '9.83', 'groupId': 'BG000'}, {'value': '66.0', 'spread': '9.31', 'groupId': 'BG001'}, {'value': '65', 'spread': '9.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2014-04-24', 'resultsFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2014-04-25', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-14', 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation', 'timeFrame': 'week 4', 'description': 'Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.'}], 'secondaryOutcomes': [{'measure': 'Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.', 'timeFrame': '8 weeks', 'description': "Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium."}, {'measure': 'Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.', 'timeFrame': '8 weeks', 'description': 'The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease', 'COPD']}, 'descriptionModule': {'briefSummary': 'The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed an Informed Consent Form\n* stable COPD according to current guidelines (GOLD 2013)\n* airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of \\<0.70 and a post-bronchodilator FEV1 of ≥30% and \\<80% of predicted normal values at Visit 2.\n* current or ex-smokers who have a smoking history of at least 10 pack years\n* Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1\n* Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).\n\nExclusion Criteria:\n\n* Pregnant or breast feeding mothers\n* Patients with conditions contraindicated for treatment\n* Patients with a history of clinically significant diseases\n* Patients who have a clinically significant renal disease\n* Patients with myocardial infarctions less than 6 months prior to study entry\n* Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.\n* Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention\n* Patients with a history of malignancy of any organ system\n* Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to Screening\n* Patients who have had a respiratory tract infection within 6 weeks prior to Screening\n* Patients with any history of asthma.'}, 'identificationModule': {'nctId': 'NCT02125734', 'acronym': 'FAVOR', 'briefTitle': 'Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Multicenter, Open-label, Cross-over Study to Assess Lung Function and Patient Preference After a 4 Week Treatment Each With QVA149 vs. Tiotropium in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD) and Moderate to Severe Airflow Limitation Who Are on a Tiotropium Therapy (FAVOR Study)', 'orgStudyIdInfo': {'id': 'CQVA149ADE04'}, 'secondaryIdInfos': [{'id': '2013-004223-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 1', 'description': 'QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56', 'interventionNames': ['Drug: QVA149', 'Drug: Tiotropium']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 2', 'description': 'Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56', 'interventionNames': ['Drug: QVA149', 'Drug: Tiotropium']}], 'interventions': [{'name': 'QVA149', 'type': 'DRUG', 'otherNames': ['indacaterol maleate/glycoporromium bromide'], 'description': 'QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day', 'armGroupLabels': ['Treatment sequence 1', 'Treatment sequence 2']}, {'name': 'Tiotropium', 'type': 'DRUG', 'description': 'Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day', 'armGroupLabels': ['Treatment sequence 1', 'Treatment sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49477', 'city': 'Ibbenbüren', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Novartis Investigative Site'}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13057', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 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'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '80686', 'city': 'München', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48147', 'city': 'Münster', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '63263', 'city': 'Neu-Isenburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.04832, 'lon': 8.69406}}, {'zip': '48431', 'city': 'Rheine', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.28509, 'lon': 7.44055}}, {'zip': '57072', 'city': 'Siegen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'zip': '42665', 'city': 'Solingen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.17343, 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