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Ignite Creation Date: 2025-12-25 @ 1:46 AM

Ignite Modification Date: 2025-12-31 @ 11:49 AM

Study NCT ID: NCT01001494

Status: COMPLETED

Last Update Posted: 2017-01-04

First Post: 2009-10-22

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Chile', 'Mexico', 'United Kingdom']}, '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': 'C542859', 'term': 'aclidinium bromide'}, {'id': 'C494814', 'term': 'BID protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZeneca Clinical', 'organization': 'Study Information Center'}, 'certainAgreement': {'otherDetails': 'All the information related to this clinical trial is considered strictly confidential and is the property of Almirall. This information will not be given to a third party without the written consent of Almirall. Publication and/or presentation, whether complete or partial, of any part of the data or results of this trial will be subject to revision and written agreement between the investigator and Almirall.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation', 'otherNumAtRisk': 277, 'otherNumAffected': 44, 'seriousNumAtRisk': 277, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation', 'otherNumAtRisk': 269, 'otherNumAffected': 38, 'seriousNumAtRisk': 269, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo via inhalation', 'otherNumAtRisk': 273, 'otherNumAffected': 56, 'seriousNumAtRisk': 273, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Chronic obstructivce pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 56}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acute Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cardiac discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Left vetricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Ligament ruptures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bladder transitional cell carcinoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Mycosis fungoides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Benign lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pancreatic neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Invertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Aortis stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Subclavian atery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Demyelinating polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Mixed deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Erythema nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo via inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.026', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.055', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '-0.073', 'spread': '0.016', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo via inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.030', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.058', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '-0.047', 'spread': '0.015', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo via inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.206', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.231', 'spread': '0.017', 'groupId': 'OG001'}, {'value': '0.022', 'spread': '0.017', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo via inhalation'}], 'classes': [{'title': 'Yes (% Patients with a 1-unit decrease)', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}, {'value': '56.9', 'groupId': 'OG001'}, {'value': '45.5', 'groupId': 'OG002'}]}]}, {'title': 'No (% Patients with a 1-unit decrease)', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}, {'value': '43.1', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}]}]}], 'paramType': 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The first patient was screened in Oct 2009 and the last patient visit was in Nov 2010.', 'preAssignmentDetails': "Patients fulfilling inclusion/exclusion criteria at the time of the Screening Visit were entered into a run-in period of 14±3 days to assess patient's disease stability."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '819', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation'}, {'id': 'BG001', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo via inhalation'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '509', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '310', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '62.0', 'spread': '8.0', 'groupId': 'BG002'}, {'value': '62.4', 'spread': '8.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '267', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '552', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, 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Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.'}, {'pmid': '27215749', 'type': 'DERIVED', 'citation': 'Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.'}, {'pmid': '25234803', 'type': 'DERIVED', 'citation': 'Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.'}, {'pmid': '22441743', 'type': 'DERIVED', 'citation': 'Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. 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