Viewing StudyNCT01045161

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Ignite Creation Date: 2025-12-17 @ 1:42 PM
Ignite Modification Date: 2025-12-23 @ 4:54 PM
Study NCT ID: NCT01045161
Status: COMPLETED
Last Update Posted: 2017-01-23
First Post: 2010-01-07
Is Possible Gene Therapy: False
Has Adverse Events: True
Brief Title: Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D004646', 'term': 'Emphysema'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542859', 'term': 'aclidinium bromide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZeneca Clinical', 'organization': 'Study Information Center'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.\n\nPublication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event reporting began in December of 2009 and concluded in July of 2011 at 112 study sites (110 in the United States and 2 additional sites in Canada).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Part A', 'description': 'Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment.', 'otherNumAtRisk': 182, 'otherNumAffected': 22, 'seriousNumAtRisk': 182, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Aclidinium Bromide 200 μg - Part A', 'description': 'Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment.', 'otherNumAtRisk': 183, 'otherNumAffected': 20, 'seriousNumAtRisk': 183, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Aclidinium Bromide 400 μg - Part A', 'description': 'Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment.', 'otherNumAtRisk': 177, 'otherNumAffected': 28, 'seriousNumAtRisk': 177, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Placebo to Aclidinium Bromide 400 μg - Part B', 'description': 'After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.', 'otherNumAtRisk': 147, 'otherNumAffected': 37, 'seriousNumAtRisk': 147, 'seriousNumAffected': 15}, {'id': 'EG004', 'title': 'Aclidinium Bromide 200μg to Aclidinium Bromide 400μg - Part B', 'description': 'Part B - After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks.', 'otherNumAtRisk': 154, 'otherNumAffected': 50, 'seriousNumAtRisk': 154, 'seriousNumAffected': 20}, {'id': 'EG005', 'title': 'Aclidinium Bromide 400μg to Aclidinium Bromide 400μg - Part B', 'description': 'After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks.', 'otherNumAtRisk': 147, 'otherNumAffected': 52, 'seriousNumAtRisk': 147, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'COPD exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 41}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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'Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg', 'description': 'Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'Aclidinium Bromide 400 μg', 'description': 'Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.008', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.043', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.064', 'spread': '0.016', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.051', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.09', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.072', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline (Week 0) to Week 12', 'description': 'Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg', 'description': 'Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.'}, {'id': 'OG002', 'title': 'Aclidinium Bromide 400 μg', 'description': 'Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.087', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.202', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.212', 'spread': '0.018', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline (Week 0) to Week 12', 'description': 'Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.'}, {'type': 'PRIMARY', 'title': 'Part B: Morning Predose (Trough) FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Aclidinium Bromide 400 μg', 'description': 'Dose matched placebo, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on placebo were switched to open label 400µg aclidinium bromide for 40 weeks'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide, 200 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg were switched to open label 400µg aclidinium bromide for 40 weeks.'}, {'id': 'OG002', 'title': 'Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide, 400 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients received open label 400µg aclidinium bromide for 40 additional weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.045', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.029', 'spread': '0.020', 'groupId': 'OG001'}, {'value': '0.048', 'spread': '0.021', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0192', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.051', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.09', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.072', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline (Week 0) to 52 Weeks', 'description': 'Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.'}, {'type': 'SECONDARY', 'title': 'Part B: Peak FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Aclidinium Bromide 400 μg', 'description': 'Dose matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo switched to open label 400µg aclidinium bromide for 40 weeks'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg switched to open label 400µg aclidinium bromide for 40 weeks'}, {'id': 'OG002', 'title': 'Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide 400 μg dose, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg switched to open label 400µg aclidinium bromide for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.185', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.176', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.172', 'spread': '0.023', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline (Week 0) to 52 Weeks', 'description': 'Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo - Part A Placebo to Aclidinium Bromide 400 μg - Part B', 'description': 'Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment. After 12 weeks, patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.'}, {'id': 'FG001', 'title': 'Aclidinium Bromide 200μg to Aclidinium Bromide 400μg', 'description': 'Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients who were Aclidinium bromide 200 microgram dose, received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.'}, {'id': 'FG002', 'title': 'Aclidinium Bromide 400μg to Aclidinium Bromide 400μg', 'description': 'Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients continued to receive Aclidinium bromide, 400 microgram dose as an open-label treatment for an additional 40 weeks'}], 'periods': [{'title': 'Part A - 12 Weeks Double Blind Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COPD Exacerbation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Part B - 40 Additional Weeks Open Label', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COPD Exacerbation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Patient recruitment occurred from December of 2009 to June of 2010 at 112 study sites (110 in the United States and 2 additional sites in Canada).', 'preAssignmentDetails': 'A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '542', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Part A / Placebo to Aclidinium Bromide 400μg Part B', 'description': 'Dose-matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment in Part A of the Trial.\n\nAfter week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.'}, {'id': 'BG001', 'title': 'Aclidinium Bromide(AB) 200μg Part A / AB 200μg to 400μg Part B', 'description': 'Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment in Part A of the Trial.\n\nAfter week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks.'}, {'id': 'BG002', 'title': 'Aclidinium Bromide(AB) 400μg Part A / AB 400μg to 400μg Part B', 'description': 'Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment in Part A of the Trial.\n\nAfter week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Part A', 'categories': [{'measurements': [{'value': '61.7', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '63.2', 'spread': '9.0', 'groupId': 'BG002'}, {'value': '62.8', 'spread': '8.9', 'groupId': 'BG003'}]}]}, {'title': 'Part B', 'categories': [{'measurements': [{'value': '61.3', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '63.1', 'spread': '8.6', 'groupId': 'BG002'}, {'value': '62.8', 'spread': '8.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≥ 40 to < 60 years - Part A', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}]}, {'title': '≥ 60 to < 70 years - Part A', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}]}, {'title': '≥ 70 years - Part A', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}]}, {'title': '≥ 40 to < 60 years - Part B', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}]}, {'title': '≥ 60 to < 70 years - Part B', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}]}, {'title': '≥ 70 years - Part B', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '288', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Part A', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '288', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Part B', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '536', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Part A', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '442', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Part B', 'unitOfMeasure': 'participants'}], 'populationDescription': 'A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Baseline characteristics for Part B are based on participant totals of 147, 154 and 147'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 544}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2012-01-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2010-01-07', 'dispFirstSubmitQcDate': '2012-01-05', 'resultsFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2010-01-07', 'dispFirstPostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-04', 'studyFirstPostDateStruct': {'date': '2010-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Change from baseline (Week 0) to Week 12', 'description': 'Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)'}, {'measure': 'Part B: Morning Predose (Trough) FEV1', 'timeFrame': 'Change from baseline (Week 0) to 52 Weeks', 'description': 'Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)'}], 'secondaryOutcomes': [{'measure': 'Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Change from baseline (Week 0) to Week 12', 'description': 'Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)'}, {'measure': 'Part B: Peak FEV1', 'timeFrame': 'Change from baseline (Week 0) to 52 Weeks', 'description': 'Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'COPD', 'Chronic Bronchitis', 'Emphysema', 'Airflow Obstruction, Chronic', 'Chronic Airflow Obstruction', 'Chronic Obstructive Airway Disease', 'Chronic Obstructive Lung Disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '24085591', 'type': 'DERIVED', 'citation': 'Rennard SI, Scanlon PD, Ferguson GT, Rekeda L, Maurer BT, Garcia Gil E, Caracta CF. ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients. Clin Drug Investig. 2013 Dec;33(12):893-904. doi: 10.1007/s40261-013-0138-1.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4070&filename=las-md-38-synopsis.pdf', 'label': 'las-md-38-synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2008; postbronchodilator FEV1/FVC \\< 70%, and postbronchodilator FEV1 ≥ 30% and \\< 80% predicted\n* Current or former cigarette smokers\n\nExclusion Criteria:\n\n* Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit\n* Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1\n* Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness\n* History or presence of asthma verified from medical records\n* Chronic use of oxygen therapy greater than or equal to 15 hours per day\n* Patient with uncontrolled infection due to HIV and/or active hepatitis\n* Patients with a history of hypersensitivity reaction to inhaled anticholinergics\n* Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.'}, 'identificationModule': {'nctId': 'NCT01045161', 'acronym': 'LAS-MD-38', 'briefTitle': 'Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose', 'orgStudyIdInfo': {'id': 'LAS-MD-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks', 'interventionNames': ['Drug: Aclidinium bromide']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks', 'interventionNames': ['Drug: Aclidinium bromide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aclidinium bromide', 'type': 'DRUG', 'description': 'Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.', 'armGroupLabels': ['1', '2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dose-matched placebo, oral inhalation twice per day for 12 weeks. 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{'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1418', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 2009', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1374', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1331', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Forest Investigative Site 1380', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '81001', 'city': 'Pueblo', 'state': 'Colorado', 'country': 'United 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