Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-31 @ 4:12 AM
Study NCT ID:
NCT01233232
Status:
COMPLETED
Last Update Posted:
2015-09-17
First Post:
2010-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597960', 'term': 'N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '4 x placebo capsules, twice daily (bid)', 'otherNumAtRisk': 29, 'otherNumAffected': 3, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid', 'otherNumAtRisk': 30, 'otherNumAffected': 8, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid', 'otherNumAtRisk': 28, 'otherNumAffected': 1, 'seriousNumAtRisk': 28, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patients Who Experienced at Least One Adverse Events(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment (Day 0) up to 28 days (End of Treatment)', 'description': 'Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last Observation on Treatment (up to Day 28)', 'description': 'Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '1.974', 'groupId': 'OG000'}, {'value': '-1.55', 'spread': '2.059', 'groupId': 'OG001'}, {'value': '-1.08', 'spread': '2.404', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.', 'unitOfMeasure': '10^9/L cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment for Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.', 'unitOfMeasure': 'degrees C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '12.1', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '15.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '8.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '-1', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '3', 'spread': '7.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.238', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.238', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.218', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.230', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.256', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.194', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28])', 'description': 'High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment for Total Protein (Urinalysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.022', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': 'NA', 'comment': 'Only one value in arm 3. SD is not calculable.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of AZD5069 After 1 Hour of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '2599.551', 'spread': '2085.601', 'groupId': 'OG001'}, {'value': '5433.611', 'spread': '4622.932', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Treatment (Day 28), 1 hour after dosing', 'description': 'At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Curve of AZD5069', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG001', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '29600', 'spread': '108', 'groupId': 'OG000', 'lowerLimit': '4270', 'upperLimit': '136000'}, {'value': '38800', 'spread': '95.6', 'groupId': 'OG001', 'lowerLimit': '6700', 'upperLimit': '143000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing', 'description': 'The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration for AZD5069', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG001', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '2550', 'spread': '107', 'groupId': 'OG000', 'lowerLimit': '367', 'upperLimit': '11700'}, {'value': '3340', 'spread': '95.6', 'groupId': 'OG001', 'lowerLimit': '576', 'upperLimit': '12300'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing', 'description': 'The maximum plasma concentration (Cmax) is the highest level of drug in plasma.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration for AZD5069', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG001', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '1.56', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '1.56'}, {'value': '1.56', 'groupId': 'OG001', 'lowerLimit': '1.56', 'upperLimit': '1.56'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing', 'description': 'Time (in relation to dosing) at which the maximum plasma concentration is observed.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Reduction of Circulating Neutrophils in Blood, From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'OG001', 'title': 'Arm 2 - AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'OG002', 'title': 'Arm 3 - AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'classes': [{'categories': [{'measurements': [{'value': '1.324', 'spread': '1.2152', 'groupId': 'OG000'}, {'value': '2.759', 'spread': '1.4422', 'groupId': 'OG001'}, {'value': '2.678', 'spread': '2.0710', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication), weeks 1, 2 and 3, and End of Treatment (Day 28)', 'description': 'The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.', 'unitOfMeasure': '10^9/L cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'FG001', 'title': 'AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'FG002', 'title': 'AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Voluntary Discontinuation by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First patient enrolled: 22 November 2010. Last patient completed: 22 March 2011. Fifteen centres across 4 countries participated in this study: Bulgaria (4), Germany (4), Hungary (4) and Ukraine (3)', 'preAssignmentDetails': '22 patients enrolled were not randomized due to eligibility not fulfilled (17 patients) and voluntary discontinuation (5 patients)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '4 x placebo capsules, twice daily (bid)'}, {'id': 'BG001', 'title': 'AZD5069 50 mg', 'description': '1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid'}, {'id': 'BG002', 'title': 'AZD5069 80 mg', 'description': '4 x 20 AZD5069 mg capsules, bid'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '65', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '65', 'spread': '7.4', 'groupId': 'BG002'}, {'value': '64', 'spread': '7.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.842', 'spread': '2.77', 'groupId': 'BG000'}, {'value': '27.645', 'spread': '2.89', 'groupId': 'BG001'}, {'value': '25.803', 'spread': '3.18', 'groupId': 'BG002'}, {'value': '26.118', 'spread': '3.14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'spread': '14.02', 'groupId': 'BG000'}, {'value': '78.9', 'spread': '9.18', 'groupId': 'BG001'}, {'value': '75.4', 'spread': '10.90', 'groupId': 'BG002'}, {'value': '76', 'spread': '11.59', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '% Predicted FEV1 at screening', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '57', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '54', 'spread': '12.1', 'groupId': 'BG002'}, {'value': '56', 'spread': '13.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1/FVC at screening', 'classes': [{'categories': [{'measurements': [{'value': '52.54', 'spread': '9.62', 'groupId': 'BG000'}, {'value': '51.75', 'spread': '11.65', 'groupId': 'BG001'}, {'value': '54.52', 'spread': '10.51', 'groupId': 'BG002'}, {'value': '52.91', 'spread': '10.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nicotine pack years', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '21.4', 'groupId': 'BG000'}, {'value': '39', 'spread': '22', 'groupId': 'BG001'}, {'value': '34', 'spread': '17.9', 'groupId': 'BG002'}, {'value': '37', 'spread': '20.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'one pack year= 1 pack (20 cigrettes) per day for 1 year, or equivalent', 'unitOfMeasure': 'Pack Year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'GOLD classification', 'classes': [{'title': 'II Moderate', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}, {'title': 'III Severe', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'The spirometric classification of severity COPD now includes four stages: Stage I: Mild; Stage II: Moderate; Stage III: Severe; Stage IV: Very Severe.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-27', 'studyFirstSubmitDate': '2010-11-02', 'resultsFirstSubmitDate': '2015-04-30', 'studyFirstSubmitQcDate': '2010-11-02', 'lastUpdatePostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-30', 'studyFirstPostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients Who Experienced at Least One Adverse Events(s)', 'timeFrame': 'From start of treatment (Day 0) up to 28 days (End of Treatment)', 'description': 'Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.'}, {'measure': 'Number of Participants With Abnormal Physical Examination Findings', 'timeFrame': 'Last Observation on Treatment (up to Day 28)', 'description': 'Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.'}, {'measure': 'Number of Participants With Abnormal Electrocardiogram (ECG)', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).'}, {'measure': 'Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.'}, {'measure': 'Change From Baseline to End of Treatment for Body Temperature', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.'}, {'measure': 'Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.'}, {'measure': 'Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.'}, {'measure': 'Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.'}, {'measure': 'Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.'}, {'measure': 'Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.'}, {'measure': 'Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)', 'timeFrame': 'Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28])', 'description': 'High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).'}, {'measure': 'Change From Baseline to End of Treatment for Total Protein (Urinalysis)', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)', 'description': 'The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration of AZD5069 After 1 Hour of Dosing', 'timeFrame': 'End of Treatment (Day 28), 1 hour after dosing', 'description': 'At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.'}, {'measure': 'Area Under the Plasma Concentration Curve of AZD5069', 'timeFrame': 'End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing', 'description': 'The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.'}, {'measure': 'Maximum Plasma Concentration for AZD5069', 'timeFrame': 'End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing', 'description': 'The maximum plasma concentration (Cmax) is the highest level of drug in plasma.'}, {'measure': 'Time to Maximum Plasma Concentration for AZD5069', 'timeFrame': 'End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing', 'description': 'Time (in relation to dosing) at which the maximum plasma concentration is observed.'}, {'measure': 'Maximum Reduction of Circulating Neutrophils in Blood, From Baseline', 'timeFrame': 'Baseline (last non-missing assessment prior to first dose of study medication), weeks 1, 2 and 3, and End of Treatment (Day 28)', 'description': 'The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.'}]}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease, Neutrophil, Respiratory Disease'], 'conditions': ['Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD)', 'Laymen Terminology Chronic Bronchitis and Emphysema']}, 'referencesModule': {'references': [{'pmid': '25681277', 'type': 'BACKGROUND', 'citation': 'Kirsten AM, Forster K, Radeczky E, Linnhoff A, Balint B, Watz H, Wray H, Salkeld L, Cullberg M, Larsson B. The safety and tolerability of oral AZD5069, a selective CXCR2 antagonist, in patients with moderate-to-severe COPD. Pulm Pharmacol Ther. 2015 Apr;31:36-41. doi: 10.1016/j.pupt.2015.02.001. Epub 2015 Feb 11.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=208&filename=D3550C00002_Revised_Clinical_Study_Protocol.pdf', 'label': 'D3550C00002\\_Revised\\_Clinical\\_Study\\_Protocol.pdf'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=208&filename=D3550C00002_Study_Synopsis.pdf', 'label': 'D3550C00002\\_Study\\_Synopsis.pdf'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of COPD with symptoms for more than one year before screening\n* Body mass index of 18-30 kg/m2 and weight of 50-100kg\n* Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening\n* FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening\n* FEV1/FVC less than 70% post-bronchodilator at screening\n\nExclusion Criteria:\n\n* Any clinically significant disease or disorder\n* Exacerbation of COPD which was not resolved within 30 days of first dosing\n* Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing\n* Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant\n* Disease history suggesting reduced or abnormal immune function other than that related to COPD'}, 'identificationModule': {'nctId': 'NCT01233232', 'acronym': 'CIRRUS', 'briefTitle': 'A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 4 Week, Double Blind, Placebo Controlled, Randomised, Parallel Group, Multicentre, Phase IIa Study to Investigate the Safety and Tolerability of AZD5069 as Oral Capsules in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'D3550C00002'}, 'secondaryIdInfos': [{'id': '2010-021217-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo dose', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Treatment arm AZD5069 50mg', 'interventionNames': ['Drug: AZD5069 50mg']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Treatment arm AZD5069 80mg', 'interventionNames': ['Drug: AZD5069 80mg']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral dose bid', 'armGroupLabels': ['1']}, {'name': 'AZD5069 50mg', 'type': 'DRUG', 'description': 'Oral dose bid', 'armGroupLabels': ['2']}, {'name': 'AZD5069 80mg', 'type': 'DRUG', 'description': 'Oral dose bid', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Pécs', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'city': 'Százhalombatta', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.32949, 'lon': 18.93878}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}