Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-04-12 @ 10:00 PM
Study NCT ID:
NCT01708057
Status:
TERMINATED
Last Update Posted:
2014-01-15
First Post:
2012-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 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': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Carin Jorup', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '21 days', 'eventGroups': [{'id': 'EG000', 'title': '50ug AZD8683', 'description': 'AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '150 ug AZD8683', 'description': 'AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '300 ug AZD8683', 'description': 'AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '900 ug AZD8683', 'description': 'AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler;', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '18ug Spiriva', 'description': 'Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Peak FEV1 (0-24h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 150 ug', 'description': 'AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG001', 'title': 'AZD8683 300ug', 'description': 'AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG002', 'title': 'AZD8683 900ug', 'description': 'AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler'}, {'id': 'OG003', 'title': 'Spiriva 18 ug', 'description': 'Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®'}, {'id': 'OG005', 'title': 'AZD8683 50ug', 'description': 'AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}], 'timeFrame': 'The first 24 hours following dose administration', 'description': 'The maximum value over 24 hours post-dose, as change from baseline', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prematurely none of the randomised patients have been analysed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Trough FEV1 (22-26h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 150 ug', 'description': 'AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG001', 'title': 'AZD8683 300ug', 'description': 'AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG002', 'title': 'AZD8683 900ug', 'description': 'AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler'}, {'id': 'OG003', 'title': 'Spiriva 18 ug', 'description': 'Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®'}, {'id': 'OG005', 'title': 'AZD8683 50ug', 'description': 'AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}], 'timeFrame': '22 to 26 hours following dose administration', 'description': 'The average over 22 to 26 hours, as change from baseline', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prematurely none of the randomized patients have been analysed.'}, {'type': 'SECONDARY', 'title': 'Average FEV1 as a Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 150 ug', 'description': 'AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG001', 'title': 'AZD8683 300ug', 'description': 'AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG002', 'title': 'AZD8683 900ug', 'description': 'AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler'}, {'id': 'OG003', 'title': 'Spiriva 18 ug', 'description': 'Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®'}, {'id': 'OG005', 'title': 'AZD8683 50ug', 'description': 'AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}], 'timeFrame': 'The first 24 hours following dose administration', 'description': 'Average FEV1 (0-24h): The average over 0 to 24 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prematurely none of the randomized patients have been analysed.'}, {'type': 'SECONDARY', 'title': 'Maximum Increase in Systolic Blood Pressure [SBP]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 150 ug', 'description': 'AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG001', 'title': 'AZD8683 300ug', 'description': 'AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG002', 'title': 'AZD8683 900ug', 'description': 'AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler'}, {'id': 'OG003', 'title': 'Spiriva 18 ug', 'description': 'Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®'}, {'id': 'OG005', 'title': 'AZD8683 50ug', 'description': 'AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}], 'timeFrame': 'baseline, 24hr post dose', 'description': 'Maximum (post-dose values - baseline value) for each treatment visit.', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prematurely none of the randomised patients have bean analysed.'}, {'type': 'SECONDARY', 'title': 'Maximum Increase in Diastolic Blood Pressure [DBP]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 150 ug', 'description': 'AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG001', 'title': 'AZD8683 300ug', 'description': 'AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG002', 'title': 'AZD8683 900ug', 'description': 'AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler'}, {'id': 'OG003', 'title': 'Spiriva 18 ug', 'description': 'Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®'}, {'id': 'OG005', 'title': 'AZD8683 50ug', 'description': 'AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}], 'timeFrame': 'The first 24 hours following dose administration', 'description': 'Maximum (post-dose values - baseline value) for each treatment visit.', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prematurely none of the randomised patients have bean analysed.'}, {'type': 'SECONDARY', 'title': 'Maximum Increase Heart Rate [HR]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 150 ug', 'description': 'AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG001', 'title': 'AZD8683 300ug', 'description': 'AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG002', 'title': 'AZD8683 900ug', 'description': 'AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler'}, {'id': 'OG003', 'title': 'Spiriva 18 ug', 'description': 'Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®'}, {'id': 'OG005', 'title': 'AZD8683 50ug', 'description': 'AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}], 'timeFrame': 'baseline, 24hr post dose', 'description': 'Maximum (post-dose values - baseline value) for each treatment visit.', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prematurely none of the randomised patients have bean analysed.'}, {'type': 'SECONDARY', 'title': 'Maximum Increase in QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 150 ug', 'description': 'AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG001', 'title': 'AZD8683 300ug', 'description': 'AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG002', 'title': 'AZD8683 900ug', 'description': 'AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler'}, {'id': 'OG003', 'title': 'Spiriva 18 ug', 'description': 'Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®'}, {'id': 'OG005', 'title': 'AZD8683 50ug', 'description': 'AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}], 'timeFrame': 'baseline, 24hr post dose', 'description': 'maximum (post-dose values - baseline value) for each treatment visit.', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prematurely none of the randomised patients have bean analysed.'}, {'type': 'SECONDARY', 'title': 'PK Parameters (AZD8683)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8683 150 ug', 'description': 'AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG001', 'title': 'AZD8683 300ug', 'description': 'AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}, {'id': 'OG002', 'title': 'AZD8683 900ug', 'description': 'AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler'}, {'id': 'OG003', 'title': 'Spiriva 18 ug', 'description': 'Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®'}, {'id': 'OG005', 'title': 'AZD8683 50ug', 'description': 'AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva'}], 'timeFrame': 'Pre-dose, 24hr post-dose', 'description': 'Cmax, tmax, AUC', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated prematurely none of the randomised patients have bean analysed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AFBECD', 'description': 'AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug'}, {'id': 'FG001', 'title': 'FEADBC', 'description': 'Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug'}, {'id': 'FG002', 'title': 'DCEBFA', 'description': 'AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal due to study termination.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 14 subjects were enrolled. Of these, 3 subjects were randomized to receive a treatment sequence consisting of 6 different treatments in random order. The study was terminated prematurely, hence only one period out of six planned was performed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Baseline', 'description': 'All Patients population'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=18 year', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '0', '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': 3}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-13', 'studyFirstSubmitDate': '2012-10-01', 'resultsFirstSubmitDate': '2013-07-30', 'studyFirstSubmitQcDate': '2012-10-15', 'lastUpdatePostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-30', 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Peak FEV1 (0-24h)', 'timeFrame': 'The first 24 hours following dose administration', 'description': 'The maximum value over 24 hours post-dose, as change from baseline'}, {'measure': 'Change From Baseline in Trough FEV1 (22-26h)', 'timeFrame': '22 to 26 hours following dose administration', 'description': 'The average over 22 to 26 hours, as change from baseline'}], 'secondaryOutcomes': [{'measure': 'Average FEV1 as a Change From Baseline', 'timeFrame': 'The first 24 hours following dose administration', 'description': 'Average FEV1 (0-24h): The average over 0 to 24 hours'}, {'measure': 'Maximum Increase in Systolic Blood Pressure [SBP]', 'timeFrame': 'baseline, 24hr post dose', 'description': 'Maximum (post-dose values - baseline value) for each treatment visit.'}, {'measure': 'Maximum Increase in Diastolic Blood Pressure [DBP]', 'timeFrame': 'The first 24 hours following dose administration', 'description': 'Maximum (post-dose values - baseline value) for each treatment visit.'}, {'measure': 'Maximum Increase Heart Rate [HR]', 'timeFrame': 'baseline, 24hr post dose', 'description': 'Maximum (post-dose values - baseline value) for each treatment visit.'}, {'measure': 'Maximum Increase in QTcF', 'timeFrame': 'baseline, 24hr post dose', 'description': 'maximum (post-dose values - baseline value) for each treatment visit.'}, {'measure': 'PK Parameters (AZD8683)', 'timeFrame': 'Pre-dose, 24hr post-dose', 'description': 'Cmax, tmax, AUC'}]}, 'conditionsModule': {'keywords': ['COPD', 'Chronic obstructive pulmonary disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'COPD']}, 'descriptionModule': {'briefSummary': 'This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.', 'detailedDescription': 'A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses 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* Provision of informed consent prior to any study specific procedures Male or female, age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue until follow-up\n* Clinical diagnosis of COPD for more than 1 year at Visit 1\n* FEV1 ≥ 30 to \\< 80% of the predicted normal value (post-bronchodilator) at Visit 2 and post-bronchodilator FEV1/FVC \\< 70%\n* Reversible airway obstruction\n\nExclusion Criteria:\n\n* Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.\n* An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS) and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or during the enrolment period\n* Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period\n* Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged by the Investigator\n* Long-term oxygen therapy, as judged by the Investigator"}, 'identificationModule': {'nctId': 'NCT01708057', 'briefTitle': 'A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-blind Placebo- and Active-controlled, Multi-centre, 6-way Cross-over, Single-dose Phase IIa Study to Investigate the Bronchodilatory and Systemic Effects of 4 Different Doses of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'D1883C00007'}, 'secondaryIdInfos': [{'id': 'EudraCT number: 2012-002900-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Single dose of AZD8683 50 µg', 'interventionNames': ['Drug: AZD8683']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Single dose of AZD8683 150 µg', 'interventionNames': ['Drug: AZD8683']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Single dose of AZD8683 300 µg', 'interventionNames': ['Drug: AZD8683']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Single dose of AZD8683 900 µg', 'interventionNames': ['Drug: AZD8683']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5', 'description': 'Single dose of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6', 'description': 'Single dose of tiotropium 18 µg', 'interventionNames': ['Drug: Tiotropium']}], 'interventions': [{'name': 'AZD8683', 'type': 'DRUG', 'description': 'AZD8683 administered via inhalation', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered via inhalation', 'armGroupLabels': ['5']}, {'name': 'Tiotropium', 'type': 'DRUG', 'description': 'Tiotropium administered via inhalation', 'armGroupLabels': ['6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Proszowice', 'country': 'Poland', 'geoPoint': {'lat': 50.19275, 'lon': 20.28909}}, {'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Gothenburg', 'country': 'Sweden', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Lund', 'country': 'Sweden', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Carin Jorup, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&DMolndal, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}