Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-05 @ 7:36 AM
Study NCT ID:
NCT03197818
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'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': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 990}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events and Adverse Drug reactions', 'timeFrame': 'Screening up to week 24', 'description': 'Adverse Events and Adverse Drug reactions'}], 'primaryOutcomes': [{'measure': 'Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24'}, {'measure': 'Change from Baseline in 2-hour post-dose FEV1 at week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from Baseline in 2-hour post-dose FEV1 at week 24'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose'}, {'measure': 'Time to First COPD exacerbation', 'timeFrame': 'Baseline to week 24', 'description': 'Time to First COPD exacerbation'}, {'measure': 'Rate of COPD exacerbations', 'timeFrame': 'Baseline to week 24', 'description': 'Rate of COPD exacerbations'}, {'measure': 'Change in COPD Assessment Test (CAT)', 'timeFrame': 'At all visits (from baseline to Week 24)', 'description': 'Change in COPD Assessment Test (CAT)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Anticholinergics', 'Triple Combination'], 'conditions': ['COPD (Chronic Obstructive Pulmonary Disease)']}, 'referencesModule': {'references': [{'pmid': '33757520', 'type': 'RESULT', 'citation': 'Zheng J, Baldi S, Zhao L, Li H, Lee KH, Singh D, Papi A, Grapin F, Guasconi A, Georges G. Efficacy and safety of single-inhaler extrafine triple therapy versus inhaled corticosteroid plus long-acting beta2 agonist in eastern Asian patients with COPD: the TRIVERSYTI randomised controlled trial. Respir Res. 2021 Mar 23;22(1):90. doi: 10.1186/s12931-021-01683-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female adults aged \\> 40 years with a diagnosis of COPD\n* Current smokers or ex-smokers\n* A post-bronchodilator FEV1 \\< 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio \\< 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI\n* At least one exacerbation in the 12 months preceding the screening visit\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Diagnosis of asthma, history of allergic rhinitis or atopy\n* Patients treated for exacerbations in the 4 weeks prior to screening visit\n* Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit\n* Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as Pro Re Nata\n* Patients requiring long term ( at least 12 hours daily) oxygen therapy for chronic hypoxemia\n* Known respiratory disorders other than COPD\n* Patients who have clinically significant cardiovascular condition'}, 'identificationModule': {'nctId': 'NCT03197818', 'acronym': 'TRIVERSYTI', 'briefTitle': 'Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'A 24-week, Double Blind, Double Dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group,Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administered Via pMDI (CHF 5993) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbuhaler®) in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'CCD-5993AA1-14'}, 'secondaryIdInfos': [{'id': 'China', 'type': 'OTHER', 'domain': 'China: Food and Drug Administration'}, {'id': 'Taiwan', 'type': 'OTHER', 'domain': 'Taiwan : Food and Drug Administration'}, {'id': 'South Korea', 'type': 'OTHER', 'domain': 'Ministry of Food and Drugs Safety'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHF 5993 100/6/12.5 µg', 'description': 'Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose (BDP/FF/GB) (Beclometasone dipropionate / Formoterol Fumarate / glycoppyronium Bromide)', 'interventionNames': ['Drug: CHF 5993 100/6/12.5 µg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Symbicort Turbuhaler 160/4.5 µg', 'description': 'Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (160µg + 4.5 µg expresses the delivered dose; 200 µg + 6 µg expresses the metered dose) ( BUD/FF) (Budesonide/Formoterol Fumarate)', 'interventionNames': ['Drug: 160 µg budesonide + 4.5 µg formoterol fumarate']}], 'interventions': [{'name': 'CHF 5993 100/6/12.5 µg', 'type': 'DRUG', 'description': 'Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose', 'armGroupLabels': ['CHF 5993 100/6/12.5 µg']}, {'name': '160 µg budesonide + 4.5 µg formoterol fumarate', 'type': 'DRUG', 'description': 'Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg', 'armGroupLabels': ['Symbicort Turbuhaler 160/4.5 µg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156031', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156026', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156017', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100144', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156012', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156045', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156002', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '528000', 'city': 'Foshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156024', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156048', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156013', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guanzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University site 156001', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}, {'zip': '524000', 'city': 'Zhanjiang', 'state': 'Guangdong', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156008', 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Chiesi Clinical Trial site 156003', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '570100', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156020', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'zip': '050000', 'city': 'Shijiangzhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156044', 'geoPoint': {'lat': 39.40013, 'lon': 118.28833}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156040', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156040', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '014000', 'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156043', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'zip': '014010', 'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156015', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'zip': '223300', 'city': "Huai'an", 'state': 'Jiangsu', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156004', 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}, {'zip': '320281', 'city': 'Jiangyin', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156033', 'geoPoint': {'lat': 31.91102, 'lon': 120.26302}}, {'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156022', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156049', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '332000', 'city': 'Jiujiang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156047', 'geoPoint': {'lat': 29.70475, 'lon': 116.00206}}, {'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156041', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156028', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '337000', 'city': 'Pingxiang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156042', 'geoPoint': {'lat': 27.61672, 'lon': 113.85353}}, {'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156023', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156036', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156019', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156007', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '750000', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156025', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156014', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156037', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156005', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156006', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156011', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '210009', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156038', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156039', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156035', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156010', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '400000', 'city': 'Chongqing', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156032'}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156034', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Chiesi clinical Trial Site 156018', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '317000', 'city': 'Linhai', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Chiesi Clinical Trial Site 156046', 'geoPoint': {'lat': 28.85535, 'lon': 121.1447}}, {'zip': '24289', 'city': 'Chuncheon', 'state': "Gang'weondo", 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410003', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '14584', 'city': 'Bucheon-si', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410012', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '420-717', 'city': 'Bucheon-si', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410001', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '10380', 'city': 'Goyang-si', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410002', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '54907', 'city': 'Jeonju', 'state': 'Jeonrabugdo', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410005', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '07345', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410008', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07985', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410007', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '100-032', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410004', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '136-705', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410006', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Gyeonggi-do', 'state': 'Seoul Teugbyeols', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410009', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '705-703', 'city': 'Daegu', 'state': 'Ulsan', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410010'}, {'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410011', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '2559', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410013', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '5030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chiesi Clinical Trial Site 410014', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '204', 'city': 'Keelung', 'state': 'Keelung Municipality', 'country': 'Taiwan', 'facility': 'Chiesi Clinical Trial Site 158001', 'geoPoint': {'lat': 25.13089, 'lon': 121.74094}}, {'zip': '83301', 'city': 'Kaohsiung City', 'state': 'Penghu', 'country': 'Taiwan', 'facility': 'Chiesi Clinical Trial Site 158004', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '500', 'city': 'Changhua', 'state': 'Taiwan Province', 'country': 'Taiwan', 'facility': 'Chiesi Clinical Trial Site 158010', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'zip': '64041', 'city': 'Douliu', 'state': 'Yunlin', 'country': 'Taiwan', 'facility': 'Chiesi Clinical Trial Site 158003', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}, {'zip': '500', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Chiesi Clinical Trial Site 158010', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'zip': '824', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chiesi Clinical Trial Site 158006', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chiesi Clinical Trial Site 158008', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Chiesi Clinical Trial Site 158005', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '220', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Chiesi Clinical Trial Site 158011', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Jinping Zheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}