Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-28 @ 6:12 PM
Study NCT ID:
NCT01049360
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2010-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}, {'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': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Esther Garcia', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'Publication of the results by the Investigator will be subject to mutual agreement between the investigator and sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days after the last dose of investigational product, for up to 24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Aclidinium 400 μg / Formoterol 12 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)', 'otherNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Aclidinium 400 μg / Formoterol 6 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)', 'otherNumAtRisk': 91, 'otherNumAffected': 0, 'seriousNumAtRisk': 91, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered twice-daily (BID)', 'otherNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumarate 12 μg twice-daily', 'otherNumAtRisk': 92, 'otherNumAffected': 0, 'seriousNumAtRisk': 92, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Placebo twice-daily', 'otherNumAtRisk': 92, 'otherNumAffected': 0, 'seriousNumAtRisk': 92, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Metastatic renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium 400 μg / Formoterol 12 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)'}, {'id': 'OG001', 'title': 'Aclidinium 400 μg / Formoterol 6 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)'}, {'id': 'OG002', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered twice-daily (BID)'}, {'id': 'OG003', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumarate 12 μg twice-daily'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo twice-daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.187', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.189', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.144', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '0.114', 'spread': '0.019', 'groupId': 'OG003'}, {'value': '-0.013', 'spread': '0.018', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.200', 'ciLowerLimit': '0.156', 'ciUpperLimit': '0.245', 'pValueComment': 'Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.022', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.202', 'ciLowerLimit': '0.158', 'ciUpperLimit': '0.245', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.022', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 12 hours post-dose on Day 14', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium 400 μg / Formoterol 12 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)'}, {'id': 'OG001', 'title': 'Aclidinium 400 μg / Formoterol 6 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)'}, {'id': 'OG002', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered twice-daily (BID)'}, {'id': 'OG003', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumarate 12 μg twice-daily'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo twice-daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.124', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.129', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.080', 'spread': '0.018', 'groupId': 'OG002'}, {'value': '0.071', 'spread': '0.018', 'groupId': 'OG003'}, {'value': '-0.008', 'spread': '0.018', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.132', 'ciLowerLimit': '0.083', 'ciUpperLimit': '0.181', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.137', 'ciLowerLimit': '0.088', 'ciUpperLimit': '0.185', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium 400 μg / Formoterol 12 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)'}, {'id': 'OG001', 'title': 'Aclidinium 400 μg / Formoterol 6 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed 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'0.026', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.275', 'ciLowerLimit': '0.224', 'ciUpperLimit': '0.325', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.026', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1', 'description': 'Aclidiunium/Formoterol 400/6 - Aclidiunium/Formoterol 400/12 - Aclidinium - Formoterol'}, {'id': 'FG001', 'title': 'Sequence 2', 'description': 'Aclidinium/Formoterol 400/12 - Aclidinium - Formoterol - Placebo'}, {'id': 'FG002', 'title': 'Sequence 3', 'description': 'Aclidinium - Formoterol - Placebo - Aclidinium/Formoterol 400/6'}, {'id': 'FG003', 'title': 'Sequence 4', 'description': 'Formoterol - Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12'}, {'id': 'FG004', 'title': 'Sequence 5', 'description': 'Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12 - Aclidinium'}, {'id': 'FG005', 'title': 'Sequence 6', 'description': 'Aclidinium/Formoterol 400/6 - Aclidinium - Placebo - Aclidinium/Formoterol 400/12'}, {'id': 'FG006', 'title': 'Sequence 7', 'description': 'Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium'}, {'id': 'FG007', 'title': 'Sequence 8', 'description': 'Aclidinium - Placebo - Aclidinium/Formoterol 400/12 - Formoterol'}, {'id': 'FG008', 'title': 'Sequence 9', 'description': 'Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium - Placebo'}, {'id': 'FG009', 'title': 'Sequence 10', 'description': 'Placebo - Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6'}, {'id': 'FG010', 'title': 'Sequence 11', 'description': 'Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12 - Placebo'}, {'id': 'FG011', 'title': 'Sequence 12', 'description': 'Aclidinium/Formoterol 400/12 - Placebo - Aclidinium - Aclidinium/Formoterol 400/6'}, {'id': 'FG012', 'title': 'Sequence 13', 'description': 'Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12'}, {'id': 'FG013', 'title': 'Sequence 14', 'description': 'Formoterol - Aclidinium/Formoterol 400/12 - Placebo - Aclidinium'}, {'id': 'FG014', 'title': 'Sequence 15', 'description': 'Placebo - Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol'}, {'id': 'FG015', 'title': 'Sequence 16', 'description': 'Aclidinium/Formoterol 400/6 - Placebo - Formoterol - Aclidinium'}, {'id': 'FG016', 'title': 'Sequence 17', 'description': 'Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo - Formoterol'}, {'id': 'FG017', 'title': 'Sequence 18', 'description': 'Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo'}, {'id': 'FG018', 'title': 'Sequence 19', 'description': 'Formoterol - Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6'}, {'id': 'FG019', 'title': 'Sequence 20', 'description': 'Placebo - Formoterol - Aclidinium - Aclidinium/Formoterol 400/12'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '6'}, {'groupId': 'FG013', 'numSubjects': '7'}, {'groupId': 'FG014', 'numSubjects': '7'}, {'groupId': 'FG015', 'numSubjects': '7'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '6'}, {'groupId': 'FG018', 'numSubjects': '6'}, {'groupId': 'FG019', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '6'}, {'groupId': 'FG014', 'numSubjects': '7'}, {'groupId': 'FG015', 'numSubjects': '7'}, {'groupId': 'FG016', 'numSubjects': '5'}, {'groupId': 'FG017', 'numSubjects': '6'}, {'groupId': 'FG018', 'numSubjects': '5'}, {'groupId': 'FG019', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', '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'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Did not meet inc/exc criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', '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': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': 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{'groupId': 'FG019', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 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'0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 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{'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '6'}, {'groupId': 'FG014', 'numSubjects': '5'}, {'groupId': 'FG015', 'numSubjects': '6'}, {'groupId': 'FG016', 'numSubjects': '5'}, {'groupId': 'FG017', 'numSubjects': '6'}, {'groupId': 'FG018', 'numSubjects': '5'}, {'groupId': 'FG019', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 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'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted in a total of 20 study centers in the United States. The first patient was screened in December 2009 and the last patient visit was in August 2010.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Population', 'description': 'Safety population defined as all randomized patients who took at least one dose of double-blind investigational product'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2011-09-30', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2010-01-13', 'dispFirstSubmitQcDate': '2011-09-30', 'resultsFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2010-01-13', 'dispFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-22', 'studyFirstPostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)', 'timeFrame': '0 to 12 hours post-dose on Day 14'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Day 14'}, {'measure': 'Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Day 14'}]}, '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': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4066&filename=lac-md-27-synopsis.pdf', 'label': 'lac-md-27-synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form\n* Be male or female aged 40 to 80 years, inclusive\n* Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of the Global Initiative for Chronic Obstructive Lung Disease (2008)\n* Be a current or former cigarette smoker with a smoking history of at least 10 pack-years\n* Have post-albuterol/salbutamol FEV1 values ≥ 30% and \\< 80% of the predicted value. FEV1 will be measured at the Screening Visit (Visit 1) between 10 and 15 minutes after inhalation of albuterol/salbutamol.\n* Have post-albuterol/salbutamol FEV1/FVC values \\< 70% (ie, 100 × post- albuterol/salbutamol FEV1/FVC \\< 70%).\n* If female, be at least 1 year postmenopausal or surgically sterile (defined as having a hysterectomy or tubal ligation). Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening\n* Be in good stable health (as judged by the Investigator) other than the COPD, based on medical history, physical examination, ECG, spirometry, and clinical laboratory data evaluations\n* Have COPD symptoms and FEV1 values at the time of randomization that are stable compared with those at Screening (Visit 1), according to the Investigator's medical judgment\n\nExclusion Criteria:\n\n* Have been hospitalized for an acute COPD exacerbation within 3 months before screening\n* Have any respiratory tract infection (including the upper respiratory tract) or signs of a COPD exacerbation or respiratory infection in the 6 weeks before Screening (Visit 1).\n* Have any clinically significant respiratory conditions other than COPD\n* Have a history or presence of asthma verified from medical records\n* Have used theophylline (including long-acting theophylline) within the previous 3 months before study entry\n* Have Stage II hypertension, defined as systolic pressure of 160 and above, and diastolic pressure of 100 and above\n* Chronic use of oxygen therapy ≥ 15 hours a day\n* Have a history, current diagnosis, or presence of exercise-induced bronchospasm\n* Have a body mass index ≥ 40 kg/m2\n* Have participated in an pulmonary rehabilitation program within the previous 3 months\n* Have clinically significant cardiovascular conditions\n* Have uncontrolled infection resulting from human immunodeficiency virus and/or active hepatitis\n* Have symptomatic prostatic hypertrophy and/or bladder neck obstruction.\n* Have narrow-angle glaucoma\n* Have a history of hypersensitivity reaction (including report of paradoxical bronchospasm) to inhaled anticholinergics (including aclidinium bromide), β2 adrenergic agonists, or any other inhaled medication or any component thereof\n* Have a QTcB, as indicated in the centralized reading report, above 470 msec in the resting ECGs performed at Screening (Visit 1) and/or patients who are using medications that may prolong the QT interval\n* Have clinically relevant abnormalities in the results of clinical laboratory tests, in ECG parameters other than QTc, in results of the physical examination,\n* Have any concurrent medical condition that, in the judgment of the Investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being\n* Do not maintain regular day/night, waking/sleeping cycles (eg, patients with history of sleep apnea syndrome or any disease related with sleep disturbances such as restless legs syndrome or somnambulism)"}, 'identificationModule': {'nctId': 'NCT01049360', 'acronym': 'LAC-MD-27', 'briefTitle': 'Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'LAC-MD-27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aclidinium 400 μg / Formoterol 12 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)', 'interventionNames': ['Drug: Aclidinium 400 μg / Formoterol 12 μg']}, {'type': 'EXPERIMENTAL', 'label': 'Aclidinium 400 μg / formoterol 6 μg', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)', 'interventionNames': ['Drug: Aclidinium 400 μg / Formoterol 6 μg']}, {'type': 'EXPERIMENTAL', 'label': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered twice-daily (BID)', 'interventionNames': ['Drug: Aclidinium 400 μg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formoterol 12 μg', 'description': 'Formoterol fumarate 12 μg twice-daily', 'interventionNames': ['Drug: Formoterol 12 μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo twice-daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aclidinium 400 μg / Formoterol 12 μg', 'type': 'DRUG', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.', 'armGroupLabels': ['Aclidinium 400 μg / Formoterol 12 μg']}, {'name': 'Aclidinium 400 μg / Formoterol 6 μg', 'type': 'DRUG', 'description': 'Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within 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