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Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS).
Sponsor: Chiesi Farmaceutici S.p.A.
Summary
The CLI-05993AB6-03 Study is an interventional study designed to investigate the safety and efficacy of a new low global warming potential propellant (HFA-152a) compared to the currently approved one (HFA-134a) in the medication (CHF5993) in patients with moderate to severe asthma
Official title: A 12-week Double-blind, Multicentre, Randomised, Active-controlled, 2-arm, Parallel-group Clinical Trial to Evaluate the Safety of CHF5993 pMDI 200/6/12.5 μg HFA-152a, Compared to CHF5993 pMDI 200/6/12.5 μg HFA-134a, in Subjects With Asthma.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
827
Start Date
2023-11-27
Completion Date
2025-02-24
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
CHF5993 200/6/12.5 μg pMDI HFA-152a
Pressurised Metered Dose Inhaler-2 inhalations twice daily
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
Pressurised Metered Dose Inhaler-2 inhalations twice daily
Locations (118)
"IPSMCPP-D-R Veleva" EOOD
Burgas, Bulgaria
Medical Center "Zdrave -1"
Kozloduy, Bulgaria
"AIPSMP Yuskyan Aliosman" Ltd
Momchilgrad, Bulgaria
Ambulatory for Specialized Outpatient Medical Care - Individual Practice
Rousse, Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov - Ruse Ltd.
Rousse, Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov
Rousse, Bulgaria
Multiprofile Hospital For Active Treatment - Shumen AD,
Shumen, Bulgaria
Diagnostic Consultative Centre 1-
Sliven, Bulgaria
MHAT Sliven to MMA Sofia
Sliven, Bulgaria
University First Multiprofile Hospital for Active Treatment -Sofia "St. Joan Krastilel" EAD
Sofia, Bulgaria
Multiprofile Hospital For Active Treatment "Knyaginya Klementina" Sofia EAD,
Sofia, Bulgaria
Medical Center Hera EOOD, 20 Klisura str., fl. 2,
Sofia, Bulgaria
Multi-profile Hospital for Active Treatment Zdraveto 2012 Ltd.,
Sofia, Bulgaria
Diagnostics and Consultation Center Convex EOOD
Sofia, Bulgaria
"Medical Center Sun i Zdrave"
Sofia, Bulgaria
Medical Center "Syrtuin" Ltd
Sofia, Bulgaria
Medical Center "New Rehabilitation Center" Ltd
Stara Zagora, Bulgaria
ASMP MC Kissiovi Ltd.
Varna, Bulgaria
Hornmed, s.r.o
Brno, Czechia
Nemocnice Jihlava, Plicní oddělení
Jihlava, Czechia
MediTrial s.r.o.
Jindřichův Hradec, Czechia
Pneumology dpt., Poliklinika Budějovická, MEDICON a.s.
Prague, Czechia
Pneumology dpt., Fakultní Thomayerova nemocnice
Prague, Czechia
Prvni plicni ambulance s.r.o
Prague, Czechia
Plicní středisko Teplice s.r.o.
Teplice, Czechia
Geo Hospitals Gardabani Multiprofile Medical Centre
Gardabani, Georgia
Geo Hospitals Gurjaani Multiprofile Medical Centre
Gurjaani, Georgia
Geo Hospitals Sagarejo Multiprofile Medical Centre
Sagarejo, Georgia
Medihelp Ltd
Samtredia, Georgia
Imermedi-Imereti Regional Medical Center. (Terjolamedi) Ltd.
T'erjola, Georgia
Curatio, Jsc
Tbilisi, Georgia
Geo Hospitals Tbilisi Multiprofile Medical Center
Tbilisi, Georgia
First Medical Center LLC
Tbilisi, Georgia
GEO HOSPITALS Zestaphoni Ambulatory Centre
Zestaponi, Georgia
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
Berlin, Germany
Lungenpraxis Hohenzollerndamm
Berlin, Germany
Klinische Forschung Berlin
Berlin, Germany
Policum Berlin Studien GmbH Friedenau
Berlin, Germany
Institut für Allergie- und Asthmaforschung
Berlin, Germany
Dr. med. Thomas Ginko Facharzt für Lungen- und Bronchialheilkunde
Bonn, Germany
Neudorfer Lungenpraxis
Duisburg, Germany
IKF Pneumologie Frankfurt Clinical Research Centre Respiratory Medicine IFS - Interdisziplinäres Facharztzentrum
Frankfurt, Germany
Athanasios Xanthopoulos Praxis für Pneumologie
Fürstenwalde, Germany
Praxis für Pneumologie und Allergologie
Leipzig, Germany
POIS Sachsen GmbH
Leipzig, Germany
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, Germany
SMO Zentrum für klinische Studien
Magdeburg, Germany
Pneumologisches Studienzentrum München
München, Germany
Siteworks Prüfzentrum Schleswig GmbH
Schleswig, Germany
Lungenpraxis Witten
Witten, Germany
"George Papanikolaou" General Hospital of Thessaloniki
Thessaloniki, Greece
University of Debrecen, Infectology Clinic Pulmonary unit
Debrecen, Hungary
Erzsébet Gondozóház
Gödöllő, Hungary
BKS Research Kft.,
Hatvan, Hungary
Revamed Kft
Nyíregyháza, Hungary
INFER-MED Kft
Pécs, Hungary
Árkádia Egészségközpont
Szombathely, Hungary
Clinica Malattie Respiratorie e allergologia IRCCS Ospedale Policlinico San Martino
Genova, Italy
University of Messina, Allergy and Clinical Immunology Unit, Department of Experimental and Clinical Medicine
Messina, Italy
Azienda Ospedaliera dei colli - Ospedale Monaldi
Naples, Italy
EB FlevoResearch BV
Almere Stad, Netherlands
Amphia Hospital
Breda, Netherlands
Gelre Hospitals Zutphen (Gelre ziekenhuizen Zutphen)
Zutphen, Netherlands
Prywatny gabinet internistyczno-alergologiczny prof. Zenon Siergiejko
Bialystok, Poland
Centrum Medycyny Oddechowej, Mróz Spółka Jawna
Bialystok, Poland
Uniwersytet Medyczny w Bialymstoku Wydzial Nauk o Zdrowiu Klinika Alergologii i Chorób Wewnetrznych
Bialystok, Poland
Prywatna praktyka lekarska. Gabinet pediatryczno - alergologiczny
Bialystok, Poland
Vitamed Galaj I Cichomski Sp. J.
Bydgoszcz, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, Poland
Private Health Care MEDYK-KRAK Sp. o.o.
Krakow, Poland
Diamond Clinic Spółka z ograniczoną odpowiedzialnością
Krakow, Poland
Małopolskie Centrum Alergologii sp. z o.o.
Krakow, Poland
ATOPIA Niepubliczny Zakład Opieki Zdrowotnej
Krakow, Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
Lodz, Poland
Makowskie Centrum Medyczne MCM "Hamernia" Maków Podhalański
Maków Podhalański, Poland
Ostrowieckie Centrum Medyczne Spółka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Poland
Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
Rzeszów, Poland
Clinmedica Research Sp. Z O.O.
Skierniewice, Poland
PULMAG Grzegorz Gąsior, Marzena Kociołek spółka cywilna
Sosnowiec, Poland
Centrum Medyczne Lucyna i Andrzej DymeK
Strzelce Opolskie, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
Tarnów, Poland
CLINICAL BEST SOLUTIONS Fiutkowski Sp. z o.o.
Warsaw, Poland
Centrum Badań Klinicznych
Wroclaw, Poland
Michał Bogacki Dobrostan
Wroclaw, Poland
Lekarze Specjaliści - J. Małolepszy I Partnerzy
Wroclaw, Poland
Angisan Grup Srl
Bragadiru, Romania
Centrul Medical Sana (SANA S.R.L.)
Bucharest, Romania
National Institute of Pneumology Marius Nasta
Bucharest, Romania
Medsana Bucharest Medical Center Srl
Bucharest, Romania
Spitalul Clinic de Pneumoftiziologie Leon Daniello
Cluj-Napoca, Romania
Spitalul Clinic de Pneumoftiziologie Leon Daniello
Cluj-Napoca, Romania
Spitalul clinic de Pneumoftiziologie Palazu Mare Constanta
Constanța, Romania
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova
Craiova, Romania
Spital Judetean de Urgenta Bihor
Oradea, Romania
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara
Timișoara, Romania
Clinical Hospital of Infectious Diseases and Pneumophysiology
Timișoara, Romania
Clinic for Pulmonary Diseases, University Clinical center of Serbia
Belgrade, Serbia
Municipal Institute for lung diseases and tuberculosis
Belgrade, Serbia
Institute for Pulmonary Diseases of Vojvodina.
Kamenica, Serbia
Clinic for Pulmonology, University Clinical Center Kragujevac.
Kragujevac, Serbia