Clinical trial NCT06029595: Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
Official title: A 52-week, Randomised, Double Blind, Multicentre, 2-arm Parallel Group Trial Assessing Efficacy of CHF6001 (Total Daily Dose 3200μg) Dry Powder Inhaler (DPI) add-on to Maintenance Medium or High Dose of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists in Subjects With Uncontrolled Asthma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Uncontrolled Asthma
Keywords: Asthma
PDE4 inhibitor
anti-inflammatory respiratory drug
Tanimilast
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, double-blind, placebo-controlled, 2-arm parallel group study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)


Eligibility criteria: Inclusion Criteria:

1. Subject's written informed consent
2. Male or female subjects aged ≥18 and ≤75 years
3. A documented history of physician-diagnosed asthma for at least 1 year and with diagnosis before the age of 50 years
4. Stable asthma therapy: a stable maintenance treatment with medium to high dose of inhaled corticosteroids plus long acting β2 agonists for at least 3 months prior to screening
5. A prebronchodilator FEV1 ≤80% of the predicted normal value
6. Bronchodilator responsiveness after inhalation of salbutamol or equivalent
7. Evidence of poorly controlled or uncontrolled asthma as based on an ACQ-7 score ≥1.5
8. History of asthma exacerbations : at least 1 asthma exacerbation leading to hospitalisation or 2 or more asthma exacerbations within the last 12 months
9. A cooperative attitude and ability to use inhalers and to comply with study procedures

Exclusion Criteria:

1. e-Diary completion compliance \<75% during run-in
2. History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit
3. Recent exacerbation or respiratory tract infection within 4 weeks prior to screening visit or during the run-in period
4. Subjects using systemic corticosteroids medication in the 4 weeks or slow-release corticosteroids in the 12 weeks prior to randomisation
5. Asthma requiring use of biologics
6. Respiratory disorders other than asthma: subjects with known respiratory disorders other than asthma
7. Subjects with a history of lung volume resection
8. Current smokers, ex-smokers with a smoking history of ≥10 pack-years or current use of inhaled or oral cannabis products.
9. Subjects with cancer or history of cancer
10. Subjects with cardiovascular diseases
11. Subjects with any abnormal and clinically significant 12-lead ECG
12. Subjects with previous medical history, evidence of an uncontrolled intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis
13. Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour
14. Patients mentally or legally incapacitated or patients accommodated in an establishment
15. Subjects with liver diseases
16. Drugs with hepatoxicity potential
17. Subjects with contra-indications to IMPs:
18. Subjects with history alcohol/drug abuse
19. Subjects with major surgery in the 3 months prior to screening visit or planned during the trial
20. Subjects treated with non-potassium sparing diuretics, nonselective β-blocking drugs, quinidine, quinidine like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation
21. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic anti-depressants
22. Subjects receiving any therapy that could interfere with the study drugs
23. Participation in another investigational trial
24. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks
25. Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
26. For females only: pregnant or lactating women

Primary outcomes:
measure: Number of Asthma exacerbation over 52 weeks of treatment
timeFrame: Over 52 weeks
Secondary outcomes:
measure: Time to first asthma exacerbation;
timeFrame: Up to 52 weeks
measure: Number of asthma exacerbation and asthma worsening over 52 weeks of treatment
timeFrame: Up to 52 weeks
measure: Time to first asthma exacerbation or asthma worsening
timeFrame: Up to 52 weeks
measure: ACQ-7 responders
timeFrame: week 4, week 26 and week 52
measure: Change from baseline in ACQ-7 and ACQ-6
timeFrame: week 4, week 26 and week 52
measure: Change from baseline in Mini-AQLQ
timeFrame: week 4, week 26 and week 52
measure: Change from baseline in pre-dose FEV1
timeFrame: week 4, week 26 and week 52
measure: Change from baseline in pre-dose FVC
timeFrame: Week4, Week 52 and Week 26
measure: Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF;
timeFrame: Up to 52 weeks
measure: Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score
timeFrame: Up to 52 weeks
measure: Change from baseline to each inter-visit period and to the entire treatment period in the percentage of rescue medication-free days, asthma symptoms-free days and asthma control days.
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Santa Fe
country: Argentina
facility: Site 032020 - Instituto Especialidades de la Salud Rosario - Clinica del Torax
state: La
city: Argentina
country: Argentina
facility: Site 032027- Centro de Medicina Respiratoria
city: Berazategui
country: Argentina
facility: Site 032025 - Sala Mignaburu
city: Buenos Aires
country: Argentina
facility: Site 032004 - CARE - Centro de Alergia y Enfermedades Respiratorias
city: Buenos Aires
country: Argentina
facility: Site 032014 - Instituto de Investigaciones en Alergia y Enfermedades Respiratorias (INAER)
city: Buenos Aires
country: Argentina
facility: Site 032021 - Centro De Investigaciones Medicas Mar Del Plata
city: Buenos Aires
country: Argentina
facility: Site 032024 -CEMLO- Consultorio Medico CEMLO LOBOS
city: Buenos Aires
country: Argentina
facility: Site 032029 - Hospital de Alta Complejidad del Bicentenario de Esteban Echeverría
city: Buenos Aires
country: Argentina
facility: Site 032030 - Instituto de Diagnostico e Investigaciones Metabolicas (IDIM)
city: Buenos Aires
country: Argentina
facility: Site 032031 - Centro de Investigaciones Metabolicas (CINME) S.A.
city: Buenos Aires
country: Argentina
facility: Site 032032 - Hospital Italiano de Buenos Aires (HIBA)
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Site 032008 - Mautalen Salud e Investigacion
city: Ciudad de Buenos Aires
country: Argentina
facility: Site 032003 -Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L
city: Corrientes
country: Argentina
facility: Site 032026 - IAAER-Instituto de Asma, Alergia y Enfermedades Respiratorias
city: Córdoba
country: Argentina
facility: Site 032005 - National University of Cordoba - Rusculleda Foundation - Instituto DAMIC
city: Florencio Varela
country: Argentina
facility: Site 032001 - Instituto de Enfermedades Respiratorias e Investigacion Medica- IERIM
city: La Plata
country: Argentina
facility: Site 032010 - Centro Platense en Investigaciones Respiratorias - CEPIR
city: Lanús
country: Argentina
facility: Site 032013 - Centro de Investigacion Medico Lanus-CIMEL CHAHIN CHAHIN S.A
city: Mar Del Plata
country: Argentina
facility: Site 032006 -Institute Fundacion Enfisema - Instituto Ave Pulmo; Hospital Privado de Comunidad (HPC)
city: Mendoza
country: Argentina
facility: Site 032002 -Consultorios Medicos Dr Isaac Scherbovsky - Fundacion Scherbovsky
city: Mendoza
country: Argentina
facility: Site 032009 - Centro Medico INSARES
city: Mendoza
country: Argentina
facility: Site 032023 - Respira Salud Clinica Integral
city: Parana
country: Argentina
facility: Site 032011 - Centro Privado de Medicina Respiratoria de Parana - CPMR
city: Rosario
country: Argentina
facility: Site 032007 - Instituto Especialidades de la Salud Rosario - Clinica del Torax
city: Rosario
country: Argentina
facility: Site 032016 - Instituto Medico de la Fundacion Estudios Clinicos
city: Rosario
country: Argentina
facility: Site 032019 - Servicio de Investigacion de Patologias Alergicas del Instituto ABC - Rosario
city: San Miguel De Tucumán
country: Argentina
facility: Site 032015 - Fundacion de Estudios Clinicos de Consultorio Integrados Rosario
city: San Miguel De Tucumán
country: Argentina
facility: Site 032018 - Instituto de Investigaciones en Patologias Respiratorias
city: San Miguel De Tucumán
country: Argentina
facility: Site 032022 - Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
city: Santa Fe de la Vera Cruz
country: Argentina
facility: Site 032012 - Instituto Del Buen Aire
city: Santa Fe
country: Argentina
facility: Site 032028 - Instituto De Investigaciones Clnicas De Rosario
city: Vicente López
country: Argentina
facility: Site 032017 - Centro Medico de Enfermedades Respiratorias (CEMER)
city: Dupnitsa
country: Bulgaria
facility: Site 100012 - Medical Center Asklepii OOD
city: Gabrovo
country: Bulgaria
facility: Site 100005 _MHAT Dr. Tota Venkova AD
city: Haskovo
country: Bulgaria
facility: Site 100011 - Medical Center Pulmo-2018 EOOD
city: Kardzhali
country: Bulgaria
facility: Site 100022 - MHAT Dr. Atanas Dafovski AD
city: Kozloduy
country: Bulgaria
facility: Site 100021 - MC Zdrave 1
city: Pernik
country: Bulgaria
facility: Site 100003 - """DCC 1 - Pernik"" EOOD"
city: Plovdiv
country: Bulgaria
facility: Site 100010 - Medical Center FAMA
city: Plovdiv
country: Bulgaria
facility: Site 100017 - MHAT Sveti Panteleymon EOOD
city: Plovdiv
country: Bulgaria
facility: Site 100025 - Dr. Filip Shterev - Individual ambulatory practice for specialized medical care
city: Razgrad
country: Bulgaria
facility: Site 100024 - Medical center Respiro
city: Ruse
country: Bulgaria
facility: Site 100006 _ Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd
city: Ruse
country: Bulgaria
facility: Site 100014 -SBALPFZ - Ruse EOOD
city: Sevlievo
country: Bulgaria
facility: Site 100029 - DCC 1 Sevlievo
city: Shumen
country: Bulgaria
facility: Site 100016 - MHAT Shumen AD
city: Sliven
country: Bulgaria
facility: Site 100004 - MHAT Dr. Ivan Seliminski AD
city: Smolyan
country: Bulgaria
facility: Site 100028 - Smolyan Clinical Research Center
city: Sofia
country: Bulgaria
facility: Site 100001- 5th MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: Site 100002 _MHAT St. Ekaterina Dimitrovgrad
city: Sofia
country: Bulgaria
facility: Site 100008 _Diagnostic Consultative Center Convex Ltd
city: Sofia
country: Bulgaria
facility: Site 100013 - MHAT Lyulin EAD
city: Sofia
country: Bulgaria
facility: Site 100015 - Hospital for Pneumatic Physiatric Diseases - Sofia
city: Sofia
country: Bulgaria
facility: Site 100018 - Medical Center Excelsior Ltd
city: Sofia
country: Bulgaria
facility: Site 100019 - Aleksandrovska University Hospital
city: Sofia
country: Bulgaria
facility: Site 100020 -Medical Centre N. I. Pirogov EOOD
city: Sofia
country: Bulgaria
facility: Site 100023 - University First Multiprofile Hospital for Active treatment-Sofia EAD
city: Sofia
country: Bulgaria
facility: Site 100030 - Medical Center Hera EOOD
city: Varna
country: Bulgaria
facility: Site 100009 - Medical Center Kissiovi
city: Varna
country: Bulgaria
facility: Site 100027 - Medical Center Research Expert
city: Vratsa
country: Bulgaria
facility: Site 100007 _SHATPPD Vratsa
city: Brandýs Nad Labem
country: Czechia
facility: Site 203001 -MUDr. I. Cierna Peterova s.r.o.
city: Brno
country: Czechia
facility: Site 203008 - Fakultni nemocnice Brno
city: Jindřichův Hradec
country: Czechia
facility: Site 203002 - MediTrial s.r.o.
city: Liskovec
country: Czechia
facility: Site 203009 - Alergologie Nemcova s.r.o
city: Mesice
country: Czechia
facility: 203004 -Nemocnice Mesice
city: Ostrava
country: Czechia
facility: Site 203006 - Nemocnice Znojmo
city: Prague
country: Czechia
facility: Site 203010 - DAWON Spol. s r.o. - Pneumologicka Ambulance
city: Prague
country: Czechia
facility: Site 203011 -Ordinace chorob plicnich s.r.o.
city: Teplice
country: Czechia
facility: Site 203003 - Plicni Stredisko Teplice, s.r.o.
city: Varnsdorf
country: Czechia
facility: Site 203005 - Ambulance Pneumologie a Ftizeologie
city: Tbilisi
country: Georgia
facility: Site 268001 - Chapidze Emergency Cardiology Center
city: Tbilisi
country: Georgia
facility: Site 268002 - JSC German Hospital
city: Tbilisi
country: Georgia
facility: Site 268003 - French Joint Hepatology Clinic Hepa
city: Tbilisi
country: Georgia
facility: Site 268004 - LTD Helsicore
city: Tbilisi
country: Georgia
facility: Site 268005 - LLC Medi Club Georgia
city: Tbilisi
country: Georgia
facility: Site 268006 - The Firsts University Clinic of Tbilisi State Medical University
city: Tbilisi
country: Georgia
facility: Site 268007 - TSMU & Ingorokva High Medical Technologies University Clinic
city: Berlin
country: Germany
facility: Site 276004 - RCMS
city: Berlin
country: Germany
facility: Site 276012 - Institut fuer Allergie- und Asthmaforschung Berlin
city: Berlin
country: Germany
facility: Site 276013 - MECS Research
city: Bonn
country: Germany
facility: Site 276010 - Office of Dr. Thomas Ginko, MD
city: Cottbus
country: Germany
facility: Site 276014 - MECS Cottbus GmbH
city: Delitzsch
country: Germany
facility: Site 276019 - Praxis Dr. Eckhardt
city: Frankfurt am Main
country: Germany
facility: Site 276007 - IKF Institut fuer klinische Forschung Frankfurt
city: Frankfurt am Main
country: Germany
facility: Site 276008 - Office of Dr. med. Claus Keller MD
city: Hamburg
country: Germany
facility: Site 276003 - ME Clinical Respiratory Research Hamburg
city: Hamburg
country: Germany
facility: Site 276015 - Velocity Clinical Research Hamburg GmbH
city: Hannover
country: Germany
facility: Site 276002 - Pneumologicum im Suedstadtforum - Hannover
city: Leipzig
country: Germany
facility: Site 276009 - Velocity Clinical Research Leipzig GmbH
city: Leipzig
country: Germany
facility: Site 276011 - POIS Sachsen GmbH
city: Leipzig
country: Germany
facility: Site 276020 - BAG Prof. Gerhard Hoheisel/Dr. Andreas Bonitz Praxis für Pneumologie und Allergologie-Studienzentrum
city: Mainz
country: Germany
facility: Site 276006 - IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz
city: Muenchen
country: Germany
facility: Site 276001 - Studienzentrum Muenchen-West; Gemeinschaftspraxis fuer Lungen- und Bronchialheilkunde Prof. Dr. med. Rainald Fischer und Dr. med. Michael Baborka
city: Rheine
country: Germany
facility: Site 276021 - Pneumologische Gemeinschaftspraxis Rheine
city: Rostock
country: Germany
facility: Site 276022 - Universitaetsmedizin Rostock
city: Saalfeld /Saale
country: Germany
facility: Site 276016 - Praxisgemeinschaft in Saalfeld - HNO
city: Schleswig
country: Germany
facility: Site 276018 - Siteworks Prufzentrum Schleswig-RespiRatio
city: Witten
country: Germany
facility: Site 276005 - Lungenzentrum Ruhr - Praxis fuer Lungenheilkunde
city: Budapest
country: Hungary
facility: Site 348006 - Bajcsy-Zsilinszky Hospital
city: Debrecen
country: Hungary
facility: Site 348003 - ClinTrial-Kenezy Hospital Institute of Clinical Pharmacology Infectology and Allergology
city: Edeleny
country: Hungary
facility: Site 348001 - Koch Robert Korhaz es Rendelointezet
city: Hajdúnánás
country: Hungary
facility: Site 348005 - Szalay Janos Rendelointezet
city: Pecs
country: Hungary
facility: Site 348004 - INFER-MED Kft. Da Vinci Maganklinika
city: Bologna
country: Italy
facility: Site 380002 - AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna
city: Foggia
country: Italy
facility: Site 380003 - Azienda Ospedaliero Universitaria OO RR di Foggia
city: Pavia
country: Italy
facility: Site 380001 - SC Pneumologia -Fondazione IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: Site 380006 - Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara
city: Roma
country: Italy
facility: Site 380005 - Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola
city: Tradate
country: Italy
facility: Site 380004 - Fondazione Salvatore Maugeri I.R.C.C.S. - Istituto Scientifico di Tradate
city: Anyang-si
country: Korea, Republic of
facility: Site 410003 - Hallym University Sacred Heart Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Site 410012 - Chungbuk National University Hospital (CBNUH)
city: Jeonju
country: Korea, Republic of
facility: Site 410004 - Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Site 410001 - Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Site 410002 - The Catholic University of Korea, Seoul St. Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Site 410005 - Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Site 410006 - Asan Medical Center (AMC)
city: Seoul
country: Korea, Republic of
facility: Site 410007 - Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Site 410008 - Severance Hospital, Yonsei University Health System
city: Suwon-si
country: Korea, Republic of
facility: Site 410009 - Ajou University Hospital
city: Balvi
country: Latvia
facility: Site 428005 - Balvi and Gulbene hospital union
city: Jurmala
country: Latvia
facility: Site 428008 - Dubultu Poliklinika
city: Riga
country: Latvia
facility: Site 428001 - Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Site 428002 - Consilium Medicum SIA
city: Riga
country: Latvia
facility: Site 428003 - Latvian University Medical Postgraduate Institute
city: Riga
country: Latvia
facility: Site 428006 - RiGa 1st Hospital
city: Riga
country: Latvia
facility: Site 428007 - SIA RAKUS
city: Kaunas
country: Lithuania
facility: Site 440002 - Hospital of Lithuanian University of Health Sciences Kauno klinikos
city: Kaunas
country: Lithuania
facility: Site 440003 - LSMU Kauno ligoninė (Kaunas Hospital of the Lithuanian University of Health Sciences)
city: Kaunas
country: Lithuania
facility: Site 440006 - CD8 Klinika
city: Vilnius
country: Lithuania
facility: Site 440001 - Viesoji Istaiga Antakalnio poliklinika
city: Białystok
country: Poland
facility: Site 616011 - Centrum Medycyny Oddechowej, Mroz Spolka Jawna
city: Bydgoszcz
country: Poland
facility: Site 616017 - NZOZ Przychodnia Vitamed
city: Elblag
country: Poland
facility: Site 616024- Mital Site
city: Grudziądz
country: Poland
facility: Site 616015 - Centrum Medyczne CLW-MED Aneta Cichomska i Joanna Luka-Wendrowska
city: Katowice
country: Poland
facility: Site 616020 - Pro Familia Altera Sp. z o.o.
city: Krakow
country: Poland
facility: Site 616001 - Malopolskie Centrum Alergologii Sp z o.o
city: Ksawerow
country: Poland
facility: Site 616018 - Prywatna Praktyka Lekarska Adam Śmiałowski - Intermed Ksawerów
city: Lodz
country: Poland
facility: Site 616007 - ETG Lodz
city: Lublin
country: Poland
facility: Site 616008 - Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
city: Lublin
country: Poland
facility: Site 616025 - MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spolka Jawna
city: Maków Podhalański
country: Poland
facility: Site 616022 - Makowskie Centrum Medyczne Hamernia Sp. z o.o.
city: Ostrowiec Świętokrzyski
country: Poland
facility: Site 616013 - Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
city: Poznan
country: Poland
facility: Site 616006 - Centrum Alergologii Teresa Hofman Sp.z.o.o
city: Poznan
country: Poland
facility: Site 616019 - Alergologia Plus
city: Poznan
country: Poland
facility: Site 616023 - Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
city: Rzeszow
country: Poland
facility: Site 616014 - Pawlukiewicz Malgorzata Prywatny Gabinet Lekarski
city: Slupsk
country: Poland
facility: Site 616005 - Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poradnia Chorob Pluc
city: Strzelce Opolskie
country: Poland
facility: Site 616004 - Centrum Medyczne Lucyna Andrazej Dymek - Strzelce Opolskie
city: Wroclaw
country: Poland
facility: Site 616016 - Michal Bogacki Dobrostan
city: Wrocław
country: Poland
facility: Site 616003 - Lekarze Specjalisci - J. Malolepszy i Partnerzy
city: Wrocław
country: Poland
facility: Site 616012 - Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy
city: Łódź
country: Poland
facility: Site 616009 - Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Łódź
country: Poland
facility: Site 616021 -IP Clinic Sp. z o.o.
city: Bragadiru
country: Romania
facility: Site 642005 - Angisan grup srl
city: Brasov
country: Romania
facility: Site 642001 - Centrul Medical de Diagnostic si Tratament Neomed
city: Bucuresti
country: Romania
facility: Site 642002 - Institute of Pneumology 'Marius Nasta'
city: Cluj-Napoca
country: Romania
facility: Site 642004 - Clinical Hospital Of Pneumology Leon Daniello
city: Cluj-Napoca
country: Romania
facility: Site 642007 - ICRH Prof DR Octavian Fodor, Sectia Medicina Interna si Ambulator Alergologie
city: Craiova
country: Romania
facility: Site 642003 - Spitalul De Boli Infectioase Victor Babes, Craiova
city: Iasi
country: Romania
facility: Site 642008 - SPITALUL CLINIC DE PNEUMOFTIZIOLOGIE IASI, Sectia Clinica I de Pneumologie
city: Timisoara
country: Romania
facility: Site 642006 - Fundatia Cardioprevent
city: Timisoara
country: Romania
facility: Site 642009 - Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
city: Benoni
country: South Africa
facility: Site 710005 - Worthwhile Clinical Trials
city: Boksburg
country: South Africa
facility: Site 710013 - Office of Dr. Agatha Cathrine Wilhase, MD
city: Cape Town
country: South Africa
facility: Site 710016 - Tsitsikamma Clinical Research Initiative
city: Durban
country: South Africa
facility: Site 710003 - Office of Dr. ZFA Vawda MD
city: Durban
country: South Africa
facility: Site 710004 - Synapta Clinical Research Center
city: Germiston
country: South Africa
facility: Site 710012 - CRISMO Research Centre
city: Johannesburg
country: South Africa
facility: Site 710015 - University Of The Witwatersrand
city: Kraaifontein
country: South Africa
facility: Site 710006 - Langeberg Medicross Medical Centre
city: Lenasia
country: South Africa
facility: Site 710002 - Lenmed- Ahmed Kathrada Private Hospital
city: Lenasia
country: South Africa
facility: Site 710007 - Ubuntu Clinical Research
city: Pretoria
country: South Africa
facility: Site 710001 - Emmed Research- Jakaranda Hospital
city: Pretoria
country: South Africa
facility: Site 710009 - Global Clinical Trials
city: Somerset West
country: South Africa
facility: Site 710011 - Busamed Paardevlei Hospital
city: Stellenbosch
country: South Africa
facility: Site 710014 - University Of Stellenbosch
city: Thabazimbi
country: South Africa
facility: Site 710010 - Limpopo Clinical Research Initiative
city: Welkom
country: South Africa
facility: Site 710008 - Welkom Clinical Trial Centre
city: Barcelona
country: Spain
facility: Site 724005 - Clinica Mi Tres Torres Barcelona
city: Jerez De La Frontera
country: Spain
facility: Site 724008 - Hospital del SAS de Jerez de la Frontera
city: Madrid
country: Spain
facility: Site 724007 - Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)
city: Málaga
country: Spain
facility: Site 724002 - Servicio Andaluz de Salud Consejeria de Salud - Hospital Universitario Virgen de la Victoria
city: Santander
country: Spain
facility: Site 724004 - Hospital Universitario Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Site 724006 - Complejo Hospitalario Universitario De Santiago
city: Vila-Real
country: Spain
facility: Site 724003 - Hospital La Plana
city: Zaragoza
country: Spain
facility: Site 724001 - Hospital Universitario Miguel Servet
Study officials:
affiliation: Universitätsmedizin Rostock
name: Johann Christian VIRCHOW, Prof
role: PRINCIPAL_INVESTIGATOR
References: