Viewing Study NCT01560234

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Ignite Creation Date: 2025-12-25 @ 2:40 AM
Ignite Modification Date: 2025-12-29 @ 10:05 AM
Study NCT ID: NCT01560234
Status: COMPLETED
Last Update Posted: 2016-06-06
First Post: 2012-03-20
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: AZD8848 Single Ascending Dose Study
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609563', 'term': 'AZD8848'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Ajay Aggarwal', 'organization': 'AstraZeneca R&D'}, 'certainAgreement': {'otherDetails': 'If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Screening up to 11 - 13 Months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Commercial 0.9% sodium chloride solution.', 'otherNumAtRisk': 16, 'otherNumAffected': 6, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1', 'description': 'AZD8848 0.15 μg', 'otherNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2', 'description': 'AZD8848 0.5 ug', 'otherNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 3', 'description': 'AZD8848 1.5 μg', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 4', 'description': 'AZD8848 5 μg', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Cohort 5', 'description': 'AZD8848 15 μg', 'otherNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 7', 'description': 'AZD8848 15 μg (Multiple Inhalation)', 'otherNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort 6 and 8', 'description': 'AZD8848 30 μg (similar investigational product administration conditions)', 'otherNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Upper respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}], 'seriousEvents': [{'term': 'Pelvic Inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Commercial 0.9% sodium chloride solution.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'AZD8848 0.15 μg'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'AZD8848 0.5 ug'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'AZD8848 1.5 μg'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'AZD8848 5 μg'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'AZD8848 15 μg'}, {'id': 'OG006', 'title': 'Cohort 7', 'description': 'AZD8848 15 μg (Multiple Inhalation)'}, {'id': 'OG007', 'title': 'Cohort 6 and 8', 'description': 'AZD8848 30 μg (similar investigational product administration conditions)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to Day 13', 'description': 'Summary of number of subjects who had at least one adverse event', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Commercial 0.9% sodium chloride solution.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'AZD8848 0.15 μg'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'AZD8848 0.5 ug'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'AZD8848 1.5 μg'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'AZD8848 5 μg'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'AZD8848 15 μg'}, {'id': 'OG006', 'title': 'Cohort 7', 'description': 'AZD8848 15 μg (Multiple Inhalation)'}, {'id': 'OG007', 'title': 'Cohort 6 and 8', 'description': 'AZD8848 30 μg (similar investigational product administration conditions)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.149', 'spread': '22.9', 'groupId': 'OG004'}, {'value': '0.360', 'spread': '43.4', 'groupId': 'OG005'}, {'value': '0.312', 'spread': '26.2', 'groupId': 'OG006'}, {'value': '0.642', 'spread': '21.9', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG004', 'OG005', 'OG006', 'OG007'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.81', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'estimateComment': 'AUC (nmol\\*h/L) 5 to 30 μg', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Commercial 0.9% sodium chloride solution.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'AZD8848 0.15 μg'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'AZD8848 0.5 ug'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'AZD8848 1.5 μg'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'AZD8848 5 μg'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'AZD8848 15 μg'}, {'id': 'OG006', 'title': 'Cohort 7', 'description': 'AZD8848 15 μg (Multiple Inhalation)'}, {'id': 'OG007', 'title': 'Cohort 6 and 8', 'description': 'AZD8848 30 μg (similar investigational product administration conditions)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.131', 'spread': '22.1', 'groupId': 'OG004'}, {'value': '0.328', 'spread': '46.2', 'groupId': 'OG005'}, {'value': '0.279', 'spread': '26.6', 'groupId': 'OG006'}, {'value': '0.591', 'spread': '22.3', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG004', 'OG005', 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'ciPctValue': '95', 'paramValue': '467.96', 'ciLowerLimit': '142.77', 'ciUpperLimit': '1533.92', 'estimateComment': 'Cohort 7/15 μg vs Placebo', 'groupDescription': '24 hour Sputum', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG007'], 'paramType': 'Comparison of Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1087.35', 'ciLowerLimit': '317.19', 'ciUpperLimit': '3727.57', 'estimateComment': 'Cohort 6 and 8/30 μg vs Placebo', 'groupDescription': '24 hour Sputum', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 Hours.', 'description': 'Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Population Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Commercial 0.9% sodium chloride solution.'}, {'id': 'FG001', 'title': 'Cohort 1', 'description': 'AZD8848 0.15 μg'}, {'id': 'FG002', 'title': 'Cohort 2', 'description': 'AZD8848 0.5 ug'}, {'id': 'FG003', 'title': 'Cohort 3', 'description': 'AZD8848 1.5 μg'}, {'id': 'FG004', 'title': 'Cohort 4', 'description': 'AZD8848 5 μg'}, {'id': 'FG005', 'title': 'Cohort 5', 'description': 'AZD8848 15 μg'}, {'id': 'FG006', 'title': 'Cohort 7', 'description': 'AZD8848 15 μg (Multiple Inhalation)'}, {'id': 'FG007', 'title': 'Cohort 6 and 8', 'description': 'AZD8848 30 μg (similar investigational product administration conditions)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'There were 47 male and female subjects (6 cohorts with additional 2 cohorts) were randomized in the study.There were 6 subjects per cohort (4 subjects received AZD8848 and 2 subjects received placebo), with the exception of Cohort 3 (1.5 μg), where 3 subjects received AZD8848 and 2 subjects received placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '47', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Commercial 0.9% sodium chloride solution.'}, {'id': 'BG001', 'title': 'Cohort 1', 'description': 'AZD8848 0.15 μg'}, {'id': 'BG002', 'title': 'Cohort 2', 'description': 'AZD8848 0.5 ug'}, {'id': 'BG003', 'title': 'Cohort 3', 'description': 'AZD8848 1.5 μg'}, {'id': 'BG004', 'title': 'Cohort 4', 'description': 'AZD8848 5 μg'}, {'id': 'BG005', 'title': 'Cohort 5', 'description': 'AZD8848 15 μg'}, {'id': 'BG006', 'title': 'Cohort 7', 'description': 'AZD8848 15 μg (Multiple Inhalation)'}, {'id': 'BG007', 'title': 'Cohort 6 and 8', 'description': 'AZD8848 30 μg (similar investigational product administration conditions)'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '6', 'groupId': 'BG000'}, {'value': '29', 'spread': '10', 'groupId': 'BG001'}, {'value': '23', 'spread': '3', 'groupId': 'BG002'}, {'value': '24', 'spread': '5', 'groupId': 'BG003'}, {'value': '31', 'spread': '4', 'groupId': 'BG004'}, {'value': '27', 'spread': '6', 'groupId': 'BG005'}, {'value': '30', 'spread': '9', 'groupId': 'BG006'}, {'value': '31', 'spread': '9', 'groupId': 'BG007'}, {'value': '28', 'spread': '7', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Subject characteristics (Height)', 'classes': [{'categories': [{'measurements': [{'value': '170.1', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '168.6', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '170.5', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '167.7', 'spread': '15.5', 'groupId': 'BG003'}, {'value': '166.0', 'spread': '5.0', 'groupId': 'BG004'}, {'value': '175.0', 'spread': '8.3', 'groupId': 'BG005'}, {'value': '169.3', 'spread': '11.1', 'groupId': 'BG006'}, {'value': '176.9', 'spread': '8.6', 'groupId': 'BG007'}, {'value': '170.9', 'spread': '8.3', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subject characteristics (Weight)', 'classes': [{'categories': [{'measurements': [{'value': '72.1', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '76.9', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '68.2', 'spread': '12.2', 'groupId': 'BG002'}, {'value': '71.4', 'spread': '5.0', 'groupId': 'BG003'}, {'value': '67.7', 'spread': '14.2', 'groupId': 'BG004'}, {'value': '78.1', 'spread': '16.3', 'groupId': 'BG005'}, {'value': '69.4', 'spread': '10.5', 'groupId': 'BG006'}, {'value': '79.3', 'spread': '8.0', 'groupId': 'BG007'}, {'value': '73.3', 'spread': '10.9', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subject characteristics (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.81', 'spread': '2.71', 'groupId': 'BG000'}, {'value': '27.02', 'spread': '1.94', 'groupId': 'BG001'}, {'value': '23.41', 'spread': '3.50', 'groupId': 'BG002'}, {'value': '25.63', 'spread': '3.16', 'groupId': 'BG003'}, {'value': '24.48', 'spread': '4.46', 'groupId': 'BG004'}, {'value': '25.31', 'spread': '3.47', 'groupId': 'BG005'}, {'value': '24.41', 'spread': '4.87', 'groupId': 'BG006'}, {'value': '25.40', 'spread': '2.37', 'groupId': 'BG007'}, {'value': '25.01', 'spread': '3.00', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All available data were used for the baseline analysis'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2012-03-20', 'resultsFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2012-03-21', 'lastUpdatePostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-05', 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Screening up to Day 13', 'description': 'Summary of number of subjects who had at least one adverse event'}, {'measure': 'Summary for Lymphocytes Laboratory Results', 'timeFrame': 'Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)'}], 'secondaryOutcomes': [{'measure': 'Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)', 'timeFrame': 'On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h'}, {'measure': 'Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)', 'timeFrame': 'On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h'}, {'measure': 'Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)', 'timeFrame': 'On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h'}, {'measure': 'Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma', 'timeFrame': 'Baseline, 24 Hours.', 'description': 'Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix'}, {'measure': 'Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma', 'timeFrame': 'Baseline, 48 Hours', 'description': 'Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix'}, {'measure': 'Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum', 'timeFrame': 'Baseline, 24 Hours.', 'description': 'Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix'}]}, 'conditionsModule': {'keywords': ['Safety', 'tolerability', 'healthy', 'pharmacokinetic', 'pharmacodynamic', 'inhaled'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '26933507', 'type': 'DERIVED', 'citation': 'Delaney S, Biffen M, Maltby J, Bell J, Asimus S, Aggarwal A, Kraan M, Keeling D. Tolerability in man following inhalation dosing of the selective TLR7 agonist, AZD8848. BMJ Open Respir Res. 2016 Feb 23;3(1):e000113. doi: 10.1136/bmjresp-2015-000113. eCollection 2016.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1660&filename=D0542C00001_CSR.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.', 'detailedDescription': 'A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men or women aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture.\n* Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method\n* Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months\n* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg\n* Ability to produce sputum of good enough quality for assessment of biomarkers\n\nExclusion Criteria:\n\n* Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (SBP \\> 140 mmHg, Diastolic blood pressure (DBP) \\> 90 mmHg, Heart rate \\< 40 or \\> 85 beats per minute)\n* Prolonged QTcF \\> 450 ms or shortened QTcF \\< 340 ms or family history of long QT syndrome\n* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848\n* History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT syndrome, or sudden death)\n* History of asthma or allergic rhinitis'}, 'identificationModule': {'nctId': 'NCT01560234', 'briefTitle': 'AZD8848 Single Ascending Dose Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'D0542C00001'}, 'secondaryIdInfos': [{'id': 'Eudract number 2011-005986-20'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD8848', 'interventionNames': ['Drug: AZD8848']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD8848', 'type': 'DRUG', 'description': 'Single dose, oral inhalation (nebuliser solution)', 'armGroupLabels': ['AZD8848']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose, oral inhalation (nebuliser solution)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ajay Aggarwal', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, 35 Gatehouse Drive, MA 02451 USA'}, {'name': 'James Ritter, BA,MA D Phil,BM BCh,MRCP,FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Quintile Drug Research Unit at Guy's Hospital Quintiles Ltd 6 Newcomen Street London SE1 1YR United Kingdom"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}