Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-29 @ 9:34 PM
Study NCT ID:
NCT01704495
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2012-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Medical Science Director Bengt Larsson', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'AZD5069 45 mg BID', 'description': 'AZD5069 oral capsules self-administered twice daily', 'otherNumAtRisk': 161, 'otherNumAffected': 86, 'seriousNumAtRisk': 161, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'AZD5069 15 mg BID', 'description': 'AZD5069 oral capsules self-administered twice daily', 'otherNumAtRisk': 153, 'otherNumAffected': 68, 'seriousNumAtRisk': 153, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'AZD5069 5 mg BID', 'description': 'AZD5069 oral capsules self-administered twice daily', 'otherNumAtRisk': 156, 'otherNumAffected': 74, 'seriousNumAtRisk': 156, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo oral capsules self-administered twice daily', 'otherNumAtRisk': 159, 'otherNumAffected': 96, 'seriousNumAtRisk': 159, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VIRAL UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RENAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LUNG NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTERINE LEIOMYOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HELICOBACTER GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SALMONELLOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'STREPTOCOCCAL SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VIRAL UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ACUTE TONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CRITICAL ILLNESS POLYNEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ISCHAEMIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PERIPHERAL EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ASTHMATIC CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BARRETTS OESOPHAGUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HIATUS HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 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[{'title': 'Subjects Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '162'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '144'}, {'groupId': 'FG003', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Discontinuation criteria met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Eligibility criteria not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}, {'title': 'Optional Safety Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '46 subjects did not enter safety extension', 'groupId': 'FG000', 'numSubjects': '116'}, {'comment': '35 subjects did not enter safety extension', 'groupId': 'FG001', 'numSubjects': '121'}, {'comment': '46 subjects did not enter safety extension', 'groupId': 'FG002', 'numSubjects': '114'}, {'comment': '46 subjects did not enter safety extension', 'groupId': 'FG003', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '83'}, {'groupId': 'FG003', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '6 months double-blind study with optional safety extension for up to 6 months, were subjects continued on the treatment they were randomized to. First subject enrolled 27 Nov 2012 Last subject last visit 27 Aug 2014 1146 subjects enrolled in tot of which 506 patients were not randomized since they did not fulfilled all the inclusion conditions.', 'preAssignmentDetails': '4 weeks run-in period on background therapy prior to randomization.\n\nThe discrepancy in the number of enrolled patients compared to the protocol section (n=1147) is because of a patient was in error reported by a monitor as enrolled when the patient was in effect not enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '640', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD5069 45 mg BID', 'description': 'AZD5069 oral capsules self-administered twice daily'}, {'id': 'BG001', 'title': 'AZD5069 15 mg BID', 'description': 'AZD5069 oral capsules self-administered twice daily'}, {'id': 'BG002', 'title': 'AZD5069 5 mg BID', 'description': 'AZD5069 oral capsules self-administered twice daily'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo oral capsules self-administred twice daily'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '52', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '53', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '54', 'spread': '11.1', 'groupId': 'BG003'}, {'value': '52', 'spread': '11.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}, {'value': '444', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '196', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'FEV1 pre-bronchodilator', 'classes': [{'categories': [{'measurements': [{'value': '63.74', 'groupId': 'BG000', 'lowerLimit': '30.11', 'upperLimit': '85.41'}, {'value': '66.35', 'groupId': 'BG001', 'lowerLimit': '29.92', 'upperLimit': '113.57'}, {'value': '65.76', 'groupId': 'BG002', 'lowerLimit': '32.57', 'upperLimit': '123.86'}, {'value': '61.58', 'groupId': 'BG003', 'lowerLimit': '31.13', 'upperLimit': '84.86'}, {'value': '64.93', 'groupId': 'BG004', 'lowerLimit': '29.92', 'upperLimit': '123.86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percentage of predicted normal', 'dispersionType': 'FULL_RANGE'}, {'title': 'FEV1 post-bronchodilator', 'classes': [{'categories': [{'measurements': [{'value': '74.34', 'groupId': 'BG000', 'lowerLimit': '32.33', 'upperLimit': '105.44'}, {'value': '77.95', 'groupId': 'BG001', 'lowerLimit': '30.38', 'upperLimit': '112.83'}, {'value': '76.31', 'groupId': 'BG002', 'lowerLimit': '34.88', 'upperLimit': '112.89'}, {'value': '72.19', 'groupId': 'BG003', 'lowerLimit': '31.26', 'upperLimit': '111.88'}, {'value': '75.22', 'groupId': 'BG004', 'lowerLimit': '30.38', 'upperLimit': '112.89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percentage of predicted normal', 'dispersionType': 'FULL_RANGE'}, {'title': 'Reversibility', 'classes': [{'categories': [{'measurements': [{'value': '18.73', 'spread': '20.617', 'groupId': 'BG000'}, {'value': '16.05', 'spread': '15.580', 'groupId': 'BG001'}, {'value': '18.41', 'spread': '20.574', 'groupId': 'BG002'}, {'value': '18.45', 'spread': '16.342', 'groupId': 'BG003'}, {'value': '17.93', 'spread': '18.438', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage change', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': 1147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-01', 'studyFirstSubmitDate': '2012-10-09', 'resultsFirstSubmitDate': '2015-06-30', 'studyFirstSubmitQcDate': '2012-10-09', 'lastUpdatePostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-01', 'studyFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Severe Asthma Exacerbations During 6 Months', 'timeFrame': 'From start of treatment up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months', 'timeFrame': 'From start of treatment up to 6 months'}, {'measure': 'Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions', 'timeFrame': 'From start of treatment up to 6 months'}, {'measure': 'Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms', 'timeFrame': 'From start of treatment up to 6 months'}, {'measure': 'Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 2 weeks after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis'}, {'measure': 'Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 1 month after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at one month are included in the analysis'}, {'measure': 'Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 2 months after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at two months are included in the analysis'}, {'measure': 'Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 3 months after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at three months are included in the analysis'}, {'measure': 'Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 4 months after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at four months are included in the analysis'}, {'measure': 'Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 6 months after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at six months are included in the analysis'}, {'measure': 'Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 2 weeks after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis'}, {'measure': 'Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 1 month after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at one month are included in the analysis'}, {'measure': 'Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 2 months after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at two months are included in the analysis'}, {'measure': 'Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 3 months after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at three months are included in the analysis'}, {'measure': 'Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 4 months after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at four months are included in the analysis'}, {'measure': 'Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1', 'timeFrame': 'Baseline (Day 0) and 6 months after Day 0', 'description': 'Only patients with both a non-missing value at baseline and visit at six months are included in the analysis'}, {'measure': 'Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score', 'timeFrame': 'Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)', 'description': 'The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).'}, {'measure': 'Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)', 'timeFrame': 'Baseline (Day 0) and 6 months after Day 0', 'description': 'The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).'}, {'measure': 'Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score', 'timeFrame': 'Baseline (Day 0), Treatment Period (1,3, and 6 months)', 'description': 'The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \\> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.'}, {'measure': 'Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score', 'timeFrame': 'Baseline (Day 0) and 6 months after Day 0', 'description': 'The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \\> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.'}, {'measure': 'Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)'}, {'measure': 'Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)'}, {'measure': 'Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)'}, {'measure': 'Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)'}, {'measure': 'Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)'}, {'measure': 'Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)'}, {'measure': 'Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)'}, {'measure': 'Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months'}, {'measure': 'Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)'}, {'measure': 'Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)'}, {'measure': 'Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)'}, {'measure': 'Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)'}, {'measure': 'Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)'}, {'measure': 'Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)'}, {'measure': 'Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)'}, {'measure': 'Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms', 'timeFrame': 'Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)'}, {'measure': 'Number of Participants With Well Controlled Asthma Weeks at Baseline', 'timeFrame': 'Last 2 weeks before randomization'}, {'measure': 'Number of Well Controlled Asthma Weeks During Treatment', 'timeFrame': 'Day 1to end of the 6 months treatment period'}, {'measure': 'Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline', 'timeFrame': 'Last 2 weeks before randomization'}, {'measure': 'Number of Uncontrolled Persistent Asthma Weeks During Treatment', 'timeFrame': 'Day 1 to end of the 6 months treatment period'}, {'measure': 'Mean Plasma Concentration of AZD5069 at Day 7', 'timeFrame': 'Day 7'}, {'measure': 'Mean Plasma Concentration of AZD5069 at 1 Month', 'timeFrame': 'at 1 month'}]}, 'conditionsModule': {'keywords': ['Uncontrolled Asthma,', 'Exacerbation,', 'Safety'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '27574788', 'type': 'DERIVED', 'citation': "O'Byrne PM, Metev H, Puu M, Richter K, Keen C, Uddin M, Larsson B, Cullberg M, Nair P. Efficacy and safety of a CXCR2 antagonist, AZD5069, in patients with uncontrolled persistent asthma: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2016 Oct;4(10):797-806. doi: 10.1016/S2213-2600(16)30227-2. Epub 2016 Aug 27."}]}, 'descriptionModule': {'briefSummary': 'The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma', 'detailedDescription': 'A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '150 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner.\n* Diagnosis of asthma for at least 12 months (GINA 2011)\n* Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year\n* Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment\n* Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)\n\nExclusion Criteria:\n\n* Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results\n* Patients with recurrent, latent, or chronic infections\n* Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment\n* Significant lower respiratory tract infection not resolved within 30 days prior to enrolment\n* Current smoker or smoking history of more than 20 pack years'}, 'identificationModule': {'nctId': 'NCT01704495', 'acronym': 'NIMBUS', 'briefTitle': 'A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study With an Optional Safety Extension Treatment Period up to 6 Months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients With Uncontrolled Persistent Asthma', 'orgStudyIdInfo': {'id': 'D3551C00001'}, 'secondaryIdInfos': [{'id': '2012-001869-33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD5069 5 mg', 'description': 'AZD5069 oral capsules self-administered twice daily', 'interventionNames': ['Drug: AZD5069']}, {'type': 'EXPERIMENTAL', 'label': 'AZD5069 15 mg', 'description': 'AZD5069 oral capsules self-administered twice daily', 'interventionNames': ['Drug: AZD5069']}, {'type': 'EXPERIMENTAL', 'label': 'AZD5069 45 mg', 'description': 'AZD5069 oral capsules self-administered twice daily', 'interventionNames': ['Drug: AZD5069']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral capsules self-administered twice daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD5069', 'type': 'DRUG', 'description': 'AZD5069 oral capsules self-administered twice daily.', 'armGroupLabels': ['AZD5069 15 mg', 'AZD5069 45 mg', 'AZD5069 5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral capsules self-administered twice daily.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gotse Delchev', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 41.56667, 'lon': 23.73333}}, {'city': 'Kozloduy', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.77691, 'lon': 23.73001}}, {'city': 'Petrich', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 41.39846, 'lon': 23.20702}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Razgrad', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.53331, 'lon': 26.51849}}, {'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Vidin', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.99159, 'lon': 22.88236}}, {'city': 'Mount Pearl', 'state': 'Newfoundland and Labrador', 'country': 'Canada', 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