Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT01205269
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2010-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], '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': 'D012120', 'term': 'Respiration Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites. AZ has the right to request delays: up to 60 days for confidential information, and an additional 90 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '1.64', 'spread': '0.47', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h', 'description': 'Maximum FEV1 value', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables'}, {'type': 'PRIMARY', 'title': 'Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.53', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '1.49', 'spread': '0.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '22 h, 24 h, 26 h', 'description': 'Trough FEV1 value', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '0.42', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h', 'description': 'Average FEV1 value', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables'}, {'type': 'SECONDARY', 'title': 'Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.35', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '3.39', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '3.28', 'spread': '0.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h', 'description': 'Maximum FVC value', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '130.7', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '131.2', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '132.2', 'spread': '13.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': 'Average systolic blood pressure value', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '77.9', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '77.5', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '77.7', 'spread': '7.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': 'Average diastolic blood pressure value', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables'}, {'type': 'SECONDARY', 'title': 'Pulse, Average Effect Over 0 - 4 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '77.3', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '76.0', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '74.9', 'spread': '9.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': 'Average pulse value', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables'}, {'type': 'SECONDARY', 'title': 'Heart Rate, Average Effect Over 0 - 4 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '75.0', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '72.8', 'spread': '11.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': 'Average heart rate value', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables'}, {'type': 'SECONDARY', 'title': 'QTcF, Average Effect Over 0 - 4 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '412.8', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '409.1', 'spread': '23.7', 'groupId': 'OG001'}, {'value': '411.9', 'spread': '22.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': "Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula", 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables'}, {'type': 'SECONDARY', 'title': 'Plasma AZD8683 Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0578', 'groupId': 'OG000', 'lowerLimit': '0.008', 'upperLimit': '0.262'}, {'value': '0.2791', 'groupId': 'OG001', 'lowerLimit': '0.030', 'upperLimit': '1.250'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h', 'description': 'Maximum plasma concentration of AZD8683', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.'}, {'type': 'SECONDARY', 'title': 'Plasma AZD8683 AUC0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 50 mcg', 'description': '1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)'}, {'id': 'OG001', 'title': 'AZD8683 200 mcg', 'description': '1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1872', 'groupId': 'OG000', 'lowerLimit': '0.013', 'upperLimit': '0.836'}, {'value': '0.8427', 'groupId': 'OG001', 'lowerLimit': '0.104', 'upperLimit': '2.764'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h', 'description': 'Area under the AZD8683 plasma concentration curve from 0 to 24 hours', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'First 50 mcg, Then 200 mcg, Then Placebo', 'description': 'period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: placebo'}, {'id': 'FG001', 'title': 'First 50 mcg, Then Placebo, Then 200 mcg', 'description': 'period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg'}, {'id': 'FG002', 'title': 'First 200 mcg, Then Placebo, Then 50 mcg', 'description': 'period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg'}, {'id': 'FG003', 'title': 'First 200 mcg, Then 50 mcg, Then Placebo', 'description': 'period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo'}, {'id': 'FG004', 'title': 'First Placebo, Then 200 mcg, Then 50 mcg', 'description': 'period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg'}, {'id': 'FG005', 'title': 'First Placebo, Then 50 mcg, Then 200 mcg', 'description': 'period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg'}], 'periods': [{'title': 'Period 1 - First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', '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'}]}]}, {'title': 'Period 2 - Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', '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'}]}]}, {'title': 'Period 3 - Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', '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'}]}]}, {'title': 'Period 4 - Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Eligibility criteria not fulfilled', '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'}]}]}, {'title': 'Period 5 - Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', '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'}]}]}], 'recruitmentDetails': 'The study has been performed at four centers in Poland. The first subject entered the study on 10 October 2010 and the last subject completed the study on 17 December 2010. The randomised population consisted of 28 patients, 27 completed the study. All patients were included in the analysis of all variables.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes all groups randomized to one of 6 sequences of drug or placebo.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2010-09-15', 'resultsFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2010-09-17', 'lastUpdatePostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-10', 'studyFirstPostDateStruct': {'date': '2010-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose', 'timeFrame': '0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h', 'description': 'Maximum FEV1 value'}, {'measure': 'Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose', 'timeFrame': '22 h, 24 h, 26 h', 'description': 'Trough FEV1 value'}], 'secondaryOutcomes': [{'measure': 'Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose', 'timeFrame': '0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h', 'description': 'Average FEV1 value'}, {'measure': 'Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose', 'timeFrame': '0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h', 'description': 'Maximum FVC value'}, {'measure': 'Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': 'Average systolic blood pressure value'}, {'measure': 'Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': 'Average diastolic blood pressure value'}, {'measure': 'Pulse, Average Effect Over 0 - 4 Hours Post-dose', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': 'Average pulse value'}, {'measure': 'Heart Rate, Average Effect Over 0 - 4 Hours Post-dose', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': 'Average heart rate value'}, {'measure': 'QTcF, Average Effect Over 0 - 4 Hours Post-dose', 'timeFrame': '0, 30 min, 2 h, 4 h', 'description': "Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula"}, {'measure': 'Plasma AZD8683 Cmax', 'timeFrame': '0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h', 'description': 'Maximum plasma concentration of AZD8683'}, {'measure': 'Plasma AZD8683 AUC0-24', 'timeFrame': '0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h', 'description': 'Area under the AZD8683 plasma concentration curve from 0 to 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease (COPD)', 'safety', 'inhalation', 'long-acting muscarinic receptor antagonist (LAMA)'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.', 'detailedDescription': 'A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of COPD\n* Current or ex-smokers\n* FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC \\< 70%\n\nExclusion Criteria:\n\n* Any clinically significant disease or disorder\n* Any clinically relevant abnormal findings at screening examinations\n* Family history or presence of glaucoma\n* Need of long term oxygen therapy'}, 'identificationModule': {'nctId': 'NCT01205269', 'briefTitle': 'The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'D1883C00004'}, 'secondaryIdInfos': [{'id': 'EudraCT number: 2010-020506-15'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First 50 mcg, then 200 mcg, then placebo', 'description': 'period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo', 'interventionNames': ['Drug: AZD8683, 50 mcg', 'Drug: Placebo', 'Drug: AZD8683, 200 mcg']}, {'type': 'EXPERIMENTAL', 'label': 'First 50 mcg, then placebo, then 200 mcg', 'description': 'period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg', 'interventionNames': ['Drug: AZD8683, 50 mcg', 'Drug: Placebo', 'Drug: AZD8683, 200 mcg']}, {'type': 'EXPERIMENTAL', 'label': 'First 200 mcg, then placebo, then 50 mcg', 'description': 'period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg', 'interventionNames': ['Drug: AZD8683, 50 mcg', 'Drug: Placebo', 'Drug: AZD8683, 200 mcg']}, {'type': 'EXPERIMENTAL', 'label': 'First 200 mcg, then 50 mcg, then placebo', 'description': 'period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo', 'interventionNames': ['Drug: AZD8683, 50 mcg', 'Drug: Placebo', 'Drug: AZD8683, 200 mcg']}, {'type': 'EXPERIMENTAL', 'label': 'First placebo, then 200 mcg, then 50 mcg', 'description': 'period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg', 'interventionNames': ['Drug: AZD8683, 50 mcg', 'Drug: Placebo', 'Drug: AZD8683, 200 mcg']}, {'type': 'EXPERIMENTAL', 'label': 'First placebo, then 50 mcg, then 200 mcg', 'description': 'period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg', 'interventionNames': ['Drug: AZD8683, 50 mcg', 'Drug: Placebo', 'Drug: AZD8683, 200 mcg']}], 'interventions': [{'name': 'AZD8683, 50 mcg', 'type': 'DRUG', 'description': 'Dry powder for inhalation, single dose', 'armGroupLabels': ['First 200 mcg, then 50 mcg, then placebo', 'First 200 mcg, then placebo, then 50 mcg', 'First 50 mcg, then 200 mcg, then placebo', 'First 50 mcg, then placebo, then 200 mcg', 'First placebo, then 200 mcg, then 50 mcg', 'First placebo, then 50 mcg, then 200 mcg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dry powder for inhalation, single dose', 'armGroupLabels': ['First 200 mcg, then 50 mcg, then placebo', 'First 200 mcg, then placebo, then 50 mcg', 'First 50 mcg, then 200 mcg, then placebo', 'First 50 mcg, then placebo, then 200 mcg', 'First placebo, then 200 mcg, then 50 mcg', 'First placebo, then 50 mcg, then 200 mcg']}, {'name': 'AZD8683, 200 mcg', 'type': 'DRUG', 'description': 'Dry powder for inhalation, single dose', 'armGroupLabels': ['First 200 mcg, then 50 mcg, then placebo', 'First 200 mcg, then placebo, then 50 mcg', 'First 50 mcg, then 200 mcg, then placebo', 'First 50 mcg, then placebo, then 200 mcg', 'First placebo, then 200 mcg, then 50 mcg', 'First placebo, then 50 mcg, then 200 mcg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bialystok', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Proszowice', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.19275, 'lon': 20.28909}}], 'overallOfficials': [{'name': 'Piotr Kuna, MD Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}