Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-11 @ 5:16 AM
Study NCT ID:
NCT00628758
Status:
COMPLETED
Last Update Posted:
2012-08-14
First Post:
2008-01-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of 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': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'phone': '+44 1509 645895', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Symbicort', 'description': 'Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)', 'otherNumAtRisk': 209, 'otherNumAffected': 0, 'seriousNumAtRisk': 209, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Conventional BP', 'description': 'Conventional Best Practice for Treatment of asthma', 'otherNumAtRisk': 221, 'otherNumAffected': 0, 'seriousNumAtRisk': 221, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Severe Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)'}, {'id': 'OG001', 'title': 'Conventional Best Practice (BP)', 'description': 'Conventional Best Practice for Treatment of asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '120.3', 'spread': '47.0', 'groupId': 'OG000'}, {'value': '103.7', 'spread': '32.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks', 'description': 'Time to severe exacerbation among patients', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-09'}, {'type': 'SECONDARY', 'title': 'Number of Severe Asthma Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)'}, {'id': 'OG001', 'title': 'Conventional BP', 'description': 'Conventional Best Practice for Treatment of asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Total number of severe asthma exacerbations per treatment group', 'unitOfMeasure': 'Severe Exacerbations', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)'}, {'id': 'OG001', 'title': 'Conventional BP', 'description': 'Conventional Best Practice for Treatment of asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '3.98', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '3.97', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 26 weeks', 'description': 'Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis was performed. Being in line with the analysis description population and due to the description of the variable. This patient-reported outcome variable could only be calculated for patients who have baseline and visit 4 AQLQ data. The AQLQ was not filled in by all enrolled patients.'}, {'type': 'SECONDARY', 'title': 'Mean Use of As-needed Medication Per Day During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)'}, {'id': 'OG001', 'title': 'Conventional BP', 'description': 'Conventional Best Practice for Treatment of asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily recording during the treatment period of 26 weeks', 'description': 'Mean use of as-needed medication per day during treatment period', 'unitOfMeasure': 'inhalations per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis was performed. Being in line with the analysis description population and due to description of the variable which was based on the patient's estimate, this variable could only be calculated of the patients who had recorded at least one estimate on their dairies they had been asked to return to the investigator at the study visits."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symbicort', 'description': 'Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)'}, {'id': 'FG001', 'title': 'Conventional BP', 'description': 'Conventional Best Practice for Treatment of asthma'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '221'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Investigator Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Treatment Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'FSI: LSI: LSO: Center type: Research and Training Host, Chest Medicine and Internal Medicine 23 Clinics. Number of enrolled subjects: 432, randomized: 430, completed patients: 344 ( Arm A:165, Arm B 179)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '430', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Symbicort', 'description': 'Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)'}, {'id': 'BG001', 'title': 'Conventional BP', 'description': 'Conventional Best Practice for Treatment of asthma'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.28', 'spread': '12.09', 'groupId': 'BG000'}, {'value': '45.17', 'spread': '12.71', 'groupId': 'BG001'}, {'value': '44.7', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2008-01-10', 'resultsFirstSubmitDate': '2009-09-18', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-06', 'studyFirstPostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Severe Asthma Exacerbation', 'timeFrame': '26 weeks', 'description': 'Time to severe exacerbation among patients'}], 'secondaryOutcomes': [{'measure': 'Number of Severe Asthma Exacerbations', 'timeFrame': '26 weeks', 'description': 'Total number of severe asthma exacerbations per treatment group'}, {'measure': 'Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score', 'timeFrame': 'Baseline and 26 weeks', 'description': 'Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.'}, {'measure': 'Mean Use of As-needed Medication Per Day During Treatment Period', 'timeFrame': 'Daily recording during the treatment period of 26 weeks', 'description': 'Mean use of as-needed medication per day during treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Symbicort', 'Turbuhaler', 'Persistent Asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.', 'detailedDescription': 'A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.\n* Ability to read and write in Turkish\n* Female or male outpatients aged 18 years\n* Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition\n* Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1\n* Either: daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment\n\nExclusion Criteria:\n\n* Previous treatment with Symbicort Single inhaler Therapy\n* Use of any b-blocking agent, including eye drops\n* Use of oral GCS as maintenance treatment\n* Known or suspected hypersensitivity to study therapy or excipients\n* A history of smoking 10 pack years\n* Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator\n* Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study'}, 'identificationModule': {'nctId': 'NCT00628758', 'acronym': 'PASSION', 'briefTitle': 'A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Comparison of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5mg, 1 Inhalation Two Times a Day (b.i.d.) Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults a -26-week, Randomized, Open-label, Parallel-group, Multicentre Study', 'orgStudyIdInfo': {'id': 'D5890L00016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Symbicort', 'description': 'Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)', 'interventionNames': ['Drug: Symbicort TBH - Turbuhaler']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional BP', 'description': 'Conventional Best Practice for Treatment of Asthma', 'interventionNames': ['Drug: beta-II-agonist, inhale steroid']}], 'interventions': [{'name': 'Symbicort TBH - Turbuhaler', 'type': 'DRUG', 'description': 'Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)', 'armGroupLabels': ['Symbicort']}, {'name': 'beta-II-agonist, inhale steroid', 'type': 'DRUG', 'otherNames': ['Astmerol inh 25 mcg/dosage, 60-120 dosage', 'Astmerol maksihaler 50 mcg/dosage, 28-60 dosage', 'Serevent diskus 50 mcg/dosage, 60 dosage', 'Serevent inh 25 mcg/dosage, 60 dosage', 'Foradil inh kap 12 mcg/dosage, 60 caps', 'Foradil inh 12 mcg/dosage, 50-100 dosage', 'Foradil combi 200 mcg', 'Foradil combi 400 mcg', 'Oxis turbuhaler 4.5-9 mcg/dosage, 60 dosage', 'Ventofor 12mg/60 inh.caps', 'Seretide disc 100-250-500 mcg/dosage 60 dosage', 'Symbicort 160/4.5 mcg/60-120 dosage, 320/9mcg/60 dosage'], 'description': 'Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage', 'armGroupLabels': ['Conventional BP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}, {'city': 'Diyarbakır', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}, {'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}, {'city': 'Eski?ehir', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site'}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}, {'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}, {'city': 'Manisa', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 38.61202, 'lon': 27.42647}}, {'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}, {'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'city': 'Zonguldak', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}], 'overallOfficials': [{'name': 'Zeynep Misirligil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Univ. Med. Fac, Chest Disease Dept'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}