Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT01120093
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2010-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542859', 'term': 'aclidinium bromide'}, {'id': 'C494814', 'term': 'BID protein, human'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'Aclidinium Bromide 100 μg Bid', 'description': 'Aclidinium bromide 100 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.', 'otherNumAtRisk': 73, 'otherNumAffected': 4, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.', 'otherNumAtRisk': 73, 'otherNumAffected': 4, 'seriousNumAtRisk': 73, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.', 'otherNumAtRisk': 74, 'otherNumAffected': 5, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Formoterol 12 μg Bid', 'description': 'Formoterol 12 μg twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days.', 'otherNumAtRisk': 74, 'otherNumAffected': 2, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Inhaled placebo dose for 7 days.', 'otherNumAtRisk': 76, 'otherNumAffected': 1, 'seriousNumAtRisk': 76, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infectious exacerbation of chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium Bromide 100 μg Bid', 'description': 'Aclidinium bromide 100 μg twice-daily via inhalation'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation'}, {'id': 'OG002', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation'}, {'id': 'OG003', 'title': 'Formoterol 12 μg Bid', 'description': 'Formoterol 12 μg twice-daily via inhalation'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo via inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.128', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.151', 'spread': '0.022', 'groupId': 'OG001'}, {'value': '0.183', 'spread': '0.022', 'groupId': 'OG002'}, {'value': '0.184', 'spread': '0.022', 'groupId': 'OG003'}, {'value': '-0.026', 'spread': '0.022', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 7', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium Bromide 100 μg Bid', 'description': 'Aclidinium bromide 100 μg twice-daily via inhalation'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation'}, {'id': 'OG002', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation'}, {'id': 'OG003', 'title': 'Formoterol 12 μg Bid', 'description': 'Formoterol 12 μg twice-daily via inhalation'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo via inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.044', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.047', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '0.086', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '0.141', 'spread': '0.021', 'groupId': 'OG003'}, {'value': '-0.103', 'spread': '0.021', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 7', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium Bromide 100 μg Bid', 'description': 'Aclidinium bromide 100 μg twice-daily via inhalation'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation'}, {'id': 'OG002', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation'}, {'id': 'OG003', 'title': 'Formoterol 12 μg Bid', 'description': 'Formoterol 12 μg twice-daily via inhalation'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo via inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.088', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.100', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '0.133', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '0.163', 'spread': '0.021', 'groupId': 'OG003'}, {'value': '-0.062', 'spread': '0.021', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 7', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium Bromide 100 μg Bid', 'description': 'Aclidinium bromide 100 μg twice-daily via inhalation'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg Bid', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation'}, {'id': 'OG002', 'title': 'Aclidinium Bromide 400 μg Bid', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation'}, {'id': 'OG003', 'title': 'Formoterol 12 μg Bid', 'description': 'Formoterol 12 μg twice-daily via inhalation'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo via inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.081', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '0.089', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.130', 'spread': '0.023', 'groupId': 'OG002'}, {'value': '0.123', 'spread': '0.023', 'groupId': 'OG003'}, {'value': '-0.025', 'spread': '0.023', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 7', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol', 'description': 'The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.\n\nIn period 1, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 2, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 3, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 4, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 5, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.'}, {'id': 'FG001', 'title': 'Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo', 'description': 'The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.\n\nIn period 1, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 2, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 3, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 4, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 5, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.'}, {'id': 'FG002', 'title': 'Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100', 'description': 'The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.\n\nIn period 1, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 2, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 3, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 4, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 5, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.'}, {'id': 'FG003', 'title': 'Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200', 'description': 'The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.\n\nIn period 1, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 2, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 3, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 4, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 5, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.'}, {'id': 'FG004', 'title': 'Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400', 'description': 'The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.\n\nIn period 1, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 2, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 3, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 4, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.\n\nIn period 5, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}, {'title': 'Treatment Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at a total of 11 centres; 10 in Germany and 1 in Belgium. The first patient was screened in Apr 2010 and the last patient visit was in Aug 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': '79', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Population', 'description': 'All patients randomized into the crossover study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.1', 'spread': '8.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2010-05-07', 'resultsFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2010-05-07', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-14', 'studyFirstPostDateStruct': {'date': '2010-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment', 'timeFrame': 'Day 7'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment', 'timeFrame': 'Day 7'}, {'measure': 'Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment', 'timeFrame': 'Day 7'}, {'measure': 'Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment', 'timeFrame': 'Day 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '22497752', 'type': 'DERIVED', 'citation': 'Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther. 2012 Jun;25(3):248-53. doi: 10.1016/j.pupt.2012.03.008. Epub 2012 Apr 4.'}], 'seeAlsoLinks': [{'url': 'http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp', 'label': 'Almirall Corporate Website'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3977&filename=Synopsis_m-34273-29-Final.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and non-pregnant, non-lactating females aged ≥ 40.\n2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC \\< 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC \\<70%).\n3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.\n4. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of salbutamol is 30% \\< FEV1 \\<80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be \\< 80% and ≥ 30%).\n5. Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.\n6. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.\n\nExclusion Criteria:\n\n1. History or current diagnosis of asthma.\n2. Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature\n3. Hospitalisation due to COPD exacerbation within the previous 3 months.\n4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.\n5. Clinically significant cardiovascular conditions\n6. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.\n7. Presence of narrow-angle glaucoma.\n8. QTcB) above 470 milliseconds in the ECG performed at Screening Visit,\n9. Patient who does not maintain regular day/night, waking/sleeping cycles'}, 'identificationModule': {'nctId': 'NCT01120093', 'briefTitle': 'Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator All Administered Twice Daily by Inhalation in Patients With Stable Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD).', 'orgStudyIdInfo': {'id': 'M/34273/29'}, 'secondaryIdInfos': [{'id': 'LAS29'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aclidinium bromide 100 μg bid', 'description': 'Aclidininum bromide 100 μg twice daily by inhalation', 'interventionNames': ['Drug: Aclidinium bromide 100 μg bid']}, {'type': 'EXPERIMENTAL', 'label': 'Aclidininum bromide 200 μg bid', 'description': 'Aclidininum bromide 200 μg twice daily by inhalation', 'interventionNames': ['Drug: Aclidinium bromide 200 μg bid']}, {'type': 'EXPERIMENTAL', 'label': 'Aclidininum bromide 400 μg bid', 'description': 'Aclidininum bromide 400 μg twice daily by inhalation', 'interventionNames': ['Drug: Aclidininum bromide 400 μg bid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo twice-daily by inhalation', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formoterol 12 μg bid', 'description': 'Formoterol 12 μg twice daily by inhalation', 'interventionNames': ['Drug: Formoterol 12 μg bid']}], 'interventions': [{'name': 'Aclidinium bromide 100 μg bid', 'type': 'DRUG', 'description': 'Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days', 'armGroupLabels': ['Aclidinium bromide 100 μg bid']}, {'name': 'Aclidinium bromide 200 μg bid', 'type': 'DRUG', 'description': 'Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days', 'armGroupLabels': ['Aclidininum bromide 200 μg bid']}, {'name': 'Aclidininum bromide 400 μg bid', 'type': 'DRUG', 'description': 'Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days', 'armGroupLabels': ['Aclidininum bromide 400 μg bid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo via inhalation in the morning and evening for 7 days', 'armGroupLabels': ['Placebo']}, {'name': 'Formoterol 12 μg bid', 'type': 'DRUG', 'description': 'Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days', 'armGroupLabels': ['Formoterol 12 μg bid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Almirall Investigational Sites#1', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#3', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#4', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#9', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#8', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '22927', 'city': 'Groβhansdorf', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#1'}, {'zip': '20249', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#5', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30159', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#7', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#2', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '19055', 'city': 'Schwerin', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#6', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'zip': '65187', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Almirall Investigational Sites#10', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Esther Garcia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}