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COMPLETED
NCT06264674
PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

CHF5993 200/6/12.5 μg pMDI HFA-152a

Pressurised Metered Dose Inhaler-2 inhalations twice daily

DRUG

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

And 18 more locations on ClinicalTrials.gov