Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 5:26 PM
Study NCT ID:
NCT00424268
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2007-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland']}, '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': 'C424423', 'term': 'Roflumilast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZeneca Clinical Study Information Center', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'The study results may be published and/or presented at scientific meetings. Prior to any submission, all manuscripts/abstracts must be presented to the sponsor for possible comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks treatment period', 'description': 'The Safety Set was based on all randomized patients who took at least one dose of the investigational drug after randomization. Three patients randomized to placebo received roflumilast instead and were included in the roflumilast group for safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Roflumilast', 'description': 'Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled', 'otherNumAtRisk': 374, 'otherNumAffected': 106, 'seriousNumAtRisk': 374, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled', 'otherNumAtRisk': 369, 'otherNumAffected': 76, 'seriousNumAtRisk': 369, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Chronic obstructive pulmonary disease', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 64, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 80, 'numAffected': 63}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 38, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Weight decreased', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lymphoid tissue hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Perianal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Post procedural myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Retinal artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Metatarsalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vascular operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast', 'description': 'Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '12', 'groupId': 'OG000'}, {'value': '-16', 'spread': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '80', 'ciLowerLimit': '51', 'ciUpperLimit': '110', 'pValueComment': 'No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline over 24 weeks of treatment', 'description': 'Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \\[L\\]', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.'}, {'type': 'SECONDARY', 'title': 'Post-bronchodilator FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast', 'description': 'Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'spread': '12', 'groupId': 'OG000'}, {'value': '-7', 'spread': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '81', 'ciLowerLimit': '51', 'ciUpperLimit': '110', 'pValueComment': 'No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline over 24 weeks of treatment', 'description': 'Mean change from baseline during the treatment period in post-bronchodilator FEV1 \\[L\\]', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis. Number of participants analyzed = number of participants with data available.'}, {'type': 'SECONDARY', 'title': 'COPD Exacerbation Rate (Moderate or Severe)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast', 'description': 'Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled'}], 'classes': [{'categories': [{'measurements': [{'value': '0.262', 'groupId': 'OG000', 'lowerLimit': '0.184', 'upperLimit': '0.375'}, {'value': '0.342', 'groupId': 'OG001', 'lowerLimit': '0.248', 'upperLimit': '0.472'}]}]}], 'analyses': [{'pValue': '0.1957', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.768', 'ciLowerLimit': '0.515', 'ciUpperLimit': '1.146', 'pValueComment': 'No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 weeks treatment period', 'description': "Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management \\[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\\].", 'unitOfMeasure': 'exacerbations per patient per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis'}, {'type': 'SECONDARY', 'title': 'Transition Dyspnea Index (TDI) Focal Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast', 'description': 'Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.7', 'pValueComment': 'This secondary endpoint was analyzed in an exploratory manner.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline over 24 weeks of treatment', 'description': 'The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis. 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Number of participants analyzed = number of participants with data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Roflumilast', 'description': 'Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Includes all randomized patients who took at least one dose of the investigational drug.', 'groupId': 'FG000', 'numSubjects': '371'}, {'comment': 'Includes all randomized patients who took at least one dose of the investigational drug.', 'groupId': 'FG001', 'numSubjects': '372'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '333'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '39'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'BG000'}, {'value': '372', 'groupId': 'BG001'}, {'value': '743', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Roflumilast', 'description': 'Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '529', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 743}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2007-01-18', 'resultsFirstSubmitDate': '2011-03-17', 'studyFirstSubmitQcDate': '2007-01-18', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-20', 'studyFirstPostDateStruct': {'date': '2007-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)', 'timeFrame': 'Change from baseline over 24 weeks of treatment', 'description': 'Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \\[L\\]'}], 'secondaryOutcomes': [{'measure': 'Post-bronchodilator FEV1', 'timeFrame': 'Change from baseline over 24 weeks of treatment', 'description': 'Mean change from baseline during the treatment period in post-bronchodilator FEV1 \\[L\\]'}, {'measure': 'COPD Exacerbation Rate (Moderate or Severe)', 'timeFrame': '24 weeks treatment period', 'description': "Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management \\[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\\]."}, {'measure': 'Transition Dyspnea Index (TDI) Focal Score', 'timeFrame': 'Change from baseline over 24 weeks of treatment', 'description': 'The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.'}, {'measure': 'Shortness of Breath Questionnaire (SOBQ) Total Score', 'timeFrame': 'Change from baseline over 24 weeks of treatment', 'description': 'Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is "not at all breathless" and five is "maximally breathless or too breathless to do the activity".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Roflumilast'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '19716961', 'type': 'RESULT', 'citation': 'Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.'}, {'pmid': '20102307', 'type': 'DERIVED', 'citation': 'Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. 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