Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT00297102
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2006-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
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': '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': '52 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. 4 patients randomized to placebo received roflumilast instead and were included in the roflumilast group for safety analyses. 1 patient was randomized twice. The second randomization is only included in the Safety Set.', 'eventGroups': [{'id': 'EG000', 'title': 'Roflumilast', 'description': '500 mcg, once daily, oral administration in the morning', 'otherNumAtRisk': 769, 'otherNumAffected': 232, 'seriousNumAtRisk': 769, 'seriousNumAffected': 144}, {'id': 'EG001', 'title': 'Placebo', 'description': 'once daily', 'otherNumAtRisk': 755, 'otherNumAffected': 136, 'seriousNumAtRisk': 755, 'seriousNumAffected': 153}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 76, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 65, 'numAffected': 50}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bronchitis', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 41, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 49, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 72, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 30, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 44, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 94, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 95, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 108, 'numAffected': 82}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bronchopulmonary aspergillosis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Wound sepsis', 'stats': 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'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Colonic pseudo-obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 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'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Physical assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 769, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 755, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', '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': '745', 'groupId': 'OG000'}, {'value': '745', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast', 'description': '500 mcg, once daily, oral administration in the morning'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '8', 'groupId': 'OG000'}, {'value': '8', 'spread': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39', 'ciLowerLimit': '18', 'ciUpperLimit': '60', 'pValueComment': 'No adjustment of the significance 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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': 'Post-bronchodilator FEV1 [L]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '736', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast', 'description': '500 mcg, once daily, oral administration in the morning'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '9', 'groupId': 'OG000'}, {'value': '8', 'spread': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49', 'ciLowerLimit': '26', 'ciUpperLimit': '71', 'pValueComment': 'No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline over 52 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. 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Number of participants analyzed = number of participants with data available.'}, {'type': 'SECONDARY', 'title': 'Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '741', 'groupId': 'OG000'}, {'value': '745', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast', 'description': '500 mcg, once daily, oral administration in the morning'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.658', 'spread': '0.084', 'groupId': 'OG000'}, {'value': '0.426', 'spread': '0.082', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0356', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.233', 'ciLowerLimit': '0.016', 'ciUpperLimit': '0.449', 'pValueComment': 'No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.111', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline over 52 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. Number of participants analyzed = number of participants with data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Roflumilast', 'description': '500 mcg, once daily, oral administration in the morning'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'once daily'}], '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': '765'}, {'comment': 'Includes all randomized patients who took at least one dose of the investigational drug.', 'groupId': 'FG001', 'numSubjects': '758'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '502'}, {'groupId': 'FG001', 'numSubjects': '525'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '233'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '765', 'groupId': 'BG000'}, {'value': '758', 'groupId': 'BG001'}, {'value': '1523', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Roflumilast', 'description': '500 mcg, once daily, oral administration in the morning'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.53', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '63.36', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '63.45', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '540', 'groupId': 'BG000'}, {'value': '538', 'groupId': 'BG001'}, {'value': '1078', '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': 1523}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2006-02-27', 'resultsFirstSubmitDate': '2011-03-17', 'studyFirstSubmitQcDate': '2006-02-27', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-20', 'studyFirstPostDateStruct': {'date': '2006-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)', 'timeFrame': 'Change from baseline over 52 weeks of treatment', 'description': 'Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \\[L\\]'}, {'measure': 'COPD Exacerbation Rate (Moderate or Severe)', 'timeFrame': '52 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\\]."}], 'secondaryOutcomes': [{'measure': 'Post-bronchodilator FEV1 [L]', 'timeFrame': 'Change from baseline over 52 weeks of treatment', 'description': 'Mean change from baseline during the treatment period in post-bronchodilator FEV1 \\[L\\]'}, {'measure': 'Time to Mortality Due to Any Reason', 'timeFrame': '52 weeks treatment period'}, {'measure': 'Natural Log-transformed C-reactive Protein (CRP)', 'timeFrame': 'Change from baseline to last post randomization measurement (52 weeks)', 'description': 'Mean change from baseline to the last post randomization measurement in natural log-transformed CRP'}, {'measure': 'Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period', 'timeFrame': 'Change from baseline over 52 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Roflumilast', 'COPD', 'Chronic obstructive pulmonary disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '19716960', 'type': 'RESULT', 'citation': 'Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1.'}, {'pmid': '28419462', 'type': 'DERIVED', 'citation': 'Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.'}, {'pmid': '24120253', 'type': 'DERIVED', 'citation': 'Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.'}, {'pmid': '23117188', 'type': 'DERIVED', 'citation': 'Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.'}, {'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 investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.\n\nFor additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* COPD patients having at least one exacerbation within last year\n* FEV1/FVC ratio (post-bronchodilator) ≤ 70%\n* FEV1 (post-bronchodilator) ≤ 50% of predicted\n\nMain Exclusion Criteria:\n\n* COPD exacerbation not resolved at first baseline visit\n* Diagnosis of asthma and/or other relevant lung disease'}, 'identificationModule': {'nctId': 'NCT00297102', 'briefTitle': 'Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Effect of Roflumilast on Exacerbation Rate in Patients With COPD. 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