Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma (TRECONY)

June 24, 2026 updated by: Chiesi Farmaceutici S.p.A.

A Phase II Multinational, Multicentre, Double-blind, Randomised, Active-controlled, 3-way Cross-over Study to Evaluate the Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a Versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in Subjects With Mild to Moderate Asthma

This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.

Study Overview

Status

Recruiting

Conditions

Asthma

Intervention / Treatment

Detailed Description

This global study aims to compare whether the investigational inhaler with the new HFA-152a propellant is as safe, effective and well tolerated in patients with asthma as the inhalers that use the existing HFA-134a propellant. HFA-152a is a propellant gas that is designed to have a lower global warming potential and to be more climate friendly. The study will be conducted in Europe, Latin America, Ukraine, South Africa and United Kingdom. It is planned to randomize 468 patients.

Study Type

Interventional

Enrollment (Estimated)

780

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Chiesi Clinical Trial Info Chiesi Clinical Trials
Phone Number: +39 0521 2791
Email: clinicaltrials_info@chiesi.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1275
    - Recruiting
    - Hospital Británico de Buenos Aires_Site n. 032029
    - Principal Investigator:
      
      Alejandro Salvado
  - Buenos Aires, Argentina, 1602
    - Recruiting
    - Centro Medico de Enfermedades Respiratorias_Site n. 032002
    - Principal Investigator:
      
      Miguel Angel Bergna
  - Buenos Aires, Argentina, 1646
    - Recruiting
    - Centro Medico Respire_Site n. 032014
    - Principal Investigator:
      
      Reynaldo Marciano Smith
  - Buenos Aires, Argentina, 1887
    - Recruiting
    - Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018
    - Principal Investigator:
      
      Rocio Fernandez Bazerque
  - Buenos Aires, Argentina, 7600
    - Recruiting
    - Centro de Investigaciones Médicas Mar del Plata_Site n. 032019
    - Principal Investigator:
      
      Manuel Naveyra
  - Buenos Aires, Argentina, C1121ABE
    - Recruiting
    - Fundacion CIDEA_Site n. 032009
    - Principal Investigator:
      
      Jorge Máspero
  - Buenos Aires, Argentina, C1427BCR
    - Recruiting
    - Centro Medico Arsema_Site n. 032003
    - Principal Investigator:
      
      Marcelo casas
  - Ciudad Autonoma de Buenos Aire, Argentina, 1056ABJ
    - Recruiting
    - Centro de Investigaciones Metabólicas (CINME)_Site n. 032025
    - Principal Investigator:
      
      Gonzalo Saenz
  - Ciudad Autonoma de Buenos Aire, Argentina, 1056ABJ
    - Recruiting
    - Centro de Medicina Respiratoria - Concepcion del Uruguay_Site n. 032015
    - Principal Investigator:
      
      Carlos Victorio
  - Ciudad Autonoma de Buenos Aire, Argentina, 1414
    - Recruiting
    - CARE - Centro de Alergia y Enfermedades Respiratorias_Site n. 032028
    - Principal Investigator:
      
      Andrea Di Cianni
  - Ciudad Autonoma de Buenos Aire, Argentina, 1426
    - Recruiting
    - Consultorio Medico Dra. Rivera_Site n. 032012
    - Principal Investigator:
      
      Mariana Rivera
  - Ciudad Autonoma de Buenos Aire, Argentina, 1426
    - Recruiting
    - Fundación Respirar Salud_Site n. 032004
    - Principal Investigator:
      
      Maria Cristina De Salvo
  - Córdoba, Argentina, X5003DCE
    - Recruiting
    - Instituto de Medicina Respiratoria (IMER) - Cordoba_Site n. 032023
    - Principal Investigator:
      
      Alexis Cazaux
  - La Plata, Argentina, 1900
    - Recruiting
    - CePIR_Site n. 032021
    - Principal Investigator:
      
      Gabriel Garcia
  - Mendoza, Argentina, 5500
    - Recruiting
    - Fundacion Scherbovsky_Site n. 032013
    - Principal Investigator:
      
      Pablo Saez Scherbovsky
  - Mendoza, Argentina, 5500
    - Recruiting
    - Instituto Medico INSARES SA_Site n. 032005
    - Principal Investigator:
      
      Pedro Elias
  - Mendoza, Argentina, 5600
    - Recruiting
    - Cimro Consultorios Medicos - Centro de Investigacion_Site n. 032006
    - Principal Investigator:
      
      Ernesto Raso
  - Quilmes, Argentina, 1878
    - Recruiting
    - Centro Respiratorio Quilmes_Site n. 032007
    - Principal Investigator:
      
      Marcelo Jose Fernandez
  - Rosario, Argentina, 2000
    - Recruiting
    - Fundacion Innovaciencia_Site n. 032017
    - Principal Investigator:
      
      German Arce
  - Rosario, Argentina, 2000
    - Recruiting
    - Instituto de Especialidades de la Salud Rosario_Site n. 032020
    - Principal Investigator:
      
      Dario Ardusso
  - Rosario, Argentina, 2000
    - Recruiting
    - Instituto Medico de la Fundacion de Estudios Clínicos_Site n. 032001
    - Principal Investigator:
      
      Tomas Alvarez
  - Rosario, Argentina, 2132
    - Recruiting
    - Fundacion Grupo Colaborativo Rosario_Site n. 032010
    - Principal Investigator:
      
      Fernando Massola Adrian
  - San Juan Bautista, Argentina, 1888
    - Recruiting
    - Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM)_Site n. 032011
    - Principal Investigator:
      
      Andrea Medina
  - San Miguel de Tucumán, Argentina, 4000
    - Recruiting
    - Centro Modelo de Cardiologia SRL_Site n. 032016
    - Principal Investigator:
      
      Roxana Maricel Willigs Rolon
  - San Miguel de Tucumán, Argentina, 4000
    - Recruiting
    - Clinica Mayo de UMCB SRL_Site n. 032026
    - Principal Investigator:
      
      María Mercedes Espeche
  - San Miguel de Tucumán, Argentina, T4000
    - Recruiting
    - Investigaciones en Patologias Respiratorias_Site n. 032022
    - Principal Investigator:
      
      Ana Maria Stok
  - Santa Fe, Argentina, 3000
    - Recruiting
    - IBAMEDICA_Site n. 032008
    - Principal Investigator:
      
      Martin Edgardo Maillo
Bosnia and Herzegovina
- - Banja Luka, Bosnia and Herzegovina, 78000
    - Recruiting
    - University Clinical Centre of the Republic of Srpska - Paprikovac_Site n. 070004
    - Principal Investigator:
      
      Maja Latincic
  - Doboj, Bosnia and Herzegovina, 74000
    - Recruiting
    - Sveti apostol Luka Doboj_Site n. 070005
    - Principal Investigator:
      
      Zeljana Panic
  - Sarajevo, Bosnia and Herzegovina, 71000
    - Recruiting
    - Dr. Abdulah Nakas General Hospital_Site n. 070007
    - Principal Investigator:
      
      Tijana Muhic-Skalonja
  - Sarajevo, Bosnia and Herzegovina, 71000
    - Recruiting
    - Dr. Abdulah Nakas General Hospital_Site n. 070009
    - Principal Investigator:
      
      Armin Hadzic
  - Sarajevo, Bosnia and Herzegovina, 71000
    - Recruiting
    - Organizational unit Novi Grad_Site n. 070003
    - Principal Investigator:
      
      Alisa Krivic
  - Siroki Brijeg, Bosnia and Herzegovina, 88226
    - Recruiting
    - University Clinical Hospital Mostar_Site n. 07001
    - Principal Investigator:
      
      Kristina Galic
  - Tešanj, Bosnia and Herzegovina, 74260
    - Recruiting
    - Opca Bolnica Tesanj_Site n. 070006
    - Principal Investigator:
      
      Besim Prnjavorac
  - Tuzla, Bosnia and Herzegovina, 75000
    - Recruiting
    - Dr. Mustafa Sehovic Public Medical Center_Site n. 070008
    - Principal Investigator:
      
      Edin Jusufovic
  - Tuzla, Bosnia and Herzegovina, 75000
    - Recruiting
    - University Clinical Centre Tuzla_Site n. 070002
    - Principal Investigator:
      
      Dzenan Halilovic
Bulgaria
- - Gorna Oryahovitsa, Bulgaria, 5100
    - Recruiting
    - MHAT Sv. Ivan Rilski - Gorna Oryahovitsa_Site n.100017
    - Principal Investigator:
      
      Ivancho Draganchev
  - Haskovo, Bulgaria, 6300
    - Recruiting
    - Medical Center Pulmo - 2018_Site n. 100007
    - Principal Investigator:
      
      Veselin Kalfov
  - Kozloduy, Bulgaria, 3320
    - Recruiting
    - MC ZDRAVE 1 - Kozloduy_Site n. 100009
    - Principal Investigator:
      
      Rumen Stoyanov Tiholov
  - Lovech, Bulgaria, 5500
    - Recruiting
    - Medical Centre Pratia Clinic EOOD - Lovech_Site n. 100012
    - Principal Investigator:
      
      Mihail Kirov
  - Pernik, Bulgaria, 2300
    - Recruiting
    - Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik EOOD_Site n. 100020
    - Principal Investigator:
      
      Galina Petrova
  - Pleven, Bulgaria, 5804
    - Recruiting
    - Multiprofile Hospital for Active Treatment "Heart and Brain" EAD_Site n. 100019
    - Principal Investigator:
      
      Iliya Krachunov
  - Plovdiv, Bulgaria, 4000
    - Recruiting
    - Medical Centre ''Unimed'' EOOD_Site n. 100003
    - Principal Investigator:
      
      Maria Dimitrova
  - Razgrad, Bulgaria, 7200
    - Recruiting
    - MHAT "St. Ivan Rilski "- Razgrad_Site 100013
    - Principal Investigator:
      
      Oleg Nemechkin
  - Razgrad, Bulgaria, 7200
    - Recruiting
    - Outpatient Practice for Specialized Medical Care in Allergology- Dr. Talyat Sali Cholak EOOD_Site 100002
    - Principal Investigator:
      
      Talyat Cholak
  - Razgrad, Bulgaria, 7200
    - Recruiting
    - Re Spiro Medical Center_Site n. 100018
    - Principal Investigator:
      
      Ivan Kiselov
  - Rousse, Bulgaria, 7002
    - Recruiting
    - Medical Center Hermes Ruse_Site n. 100011
    - Principal Investigator:
      
      Nikolay Nikolaev
  - Rousse, Bulgaria, 7002
    - Recruiting
    - SHATPPD "Dr. Dimitar Gramatikov" Ruse EOOD_Site n. 100004
    - Principal Investigator:
      
      Elena Docheva
  - Sliven, Bulgaria, 8800
    - Recruiting
    - Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski" - Sliven AD_Site n.100014
    - Principal Investigator:
      
      Petyo Petkov
  - Sofia, Bulgaria, 1000
    - Recruiting
    - Medical Center Hera EOOD_Site n. 100006
    - Principal Investigator:
      
      Gergana Ilieva-Georgieva
  - Sofia, Bulgaria, 1142
    - Recruiting
    - University First Multiprofile Hospital for Active Treatment - Sofia "St. John the Baptist"_Site n. 100016
    - Principal Investigator:
      
      Dinko Valev
  - Sofia, Bulgaria, 1202
    - Recruiting
    - Specialized Hospital for Active Treatment Pneumo- Phthisiatric Diseases - Sofia District EOOD_Site n. 100021
    - Principal Investigator:
      
      Nadya Koteva
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Multi-profile hospital for active treatment Lozenets EAD_Site n. 100008
    - Principal Investigator:
      
      Svetlomir Takov
  - Stara Zagora, Bulgaria, 6000
    - Recruiting
    - Preventsia 2000 - Medical Centre for Outpatient Medical Care OOD_Site n. 100005
    - Principal Investigator:
      
      Vanya Dimova Ilieva-Fartunova
  - Stara Zagora, Bulgaria, 6000
    - Recruiting
    - University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD_Site n.100015
    - Principal Investigator:
      
      Damyan Arabadzhiev
  - Stara Zagora, Bulgaria, 6001
    - Recruiting
    - Medical Centre New Rehabilitation Centre EOOD_Site n. 100010
    - Principal Investigator:
      
      Gyongyver Szaloky
  - Varna, Bulgaria, 9020
    - Recruiting
    - Medical Centre Pratia Clinic EOOD - Varna_Site 100001
    - Principal Investigator:
      
      Iskra Velichkova
Czechia
- - Jindřichův Hradec, Czechia, 377 01
    - Recruiting
    - MEDITRIAL, s.r.o._Site n. 203003
    - Principal Investigator:
      
      Petr Kopecky
  - Louny, Czechia, 44001
    - Recruiting
    - Plicni Ambulance Louny s.r.o - Louny_Site n. 203001
    - Principal Investigator:
      
      Michala Cervena Sulcova
  - Lovosice, Czechia, 41002
    - Recruiting
    - Cefispiro s.r.o_Site n. 203006
    - Principal Investigator:
      
      Petra Filipova
  - Miroslav, Czechia, 67271
    - Recruiting
    - MUDr. Ilona Pavlišová sro_Site n. 203007
    - Principal Investigator:
      
      Ilona Pavlisova
  - Měšice, Czechia, 25064
    - Recruiting
    - Nemocnice Mesice - Centrum integrovane onkologicke pece, z.s., Plicni ambulance_Site n. 203004
    - Principal Investigator:
      
      Jaromir Musil
  - Teplice, Czechia, 41501
    - Recruiting
    - Plicní středisko Teplice s.r.o._Site n. 203002
    - Principal Investigator:
      
      Stanislav Holub
  - Varnsdorf, Czechia, 40747
    - Recruiting
    - PNEUMOLOGIE Varnsdorf_Site n. 203005
    - Principal Investigator:
      
      Milan Sklenar
Germany
- - Ahrensburg, Germany, 22926
    - Recruiting
    - Velocity Clinical Research Germany, Ahrensburg_Site n. 276020
    - Principal Investigator:
      
      Sameer Kulkarni
  - Berlin, Germany, 10119
    - Recruiting
    - Studienpraxis Berlin-Brandenburg_Site n. 276005
    - Principal Investigator:
      
      Lennart Schaper
  - Berlin, Germany, 10625
    - Recruiting
    - Praxis an der Oper_Site n. 276016
    - Principal Investigator:
      
      Thomas Lienert
  - Berlin, Germany, 10717
    - Recruiting
    - Lungenpraxis Hohenzollerndamm_Site n. 276004
    - Principal Investigator:
      
      Anneliese Linnhoff
  - Berlin, Germany, 10787
    - Recruiting
    - Velocity Clinical Research Germany GmbH_Site 276010
    - Principal Investigator:
      
      Isabelle Schenkenberger
  - Berlin, Germany, 12157
    - Recruiting
    - Polikum Institut GmbH_Site n. 276006
    - Principal Investigator:
      
      Michael Sebert
  - Berlin, Germany, 12159
    - Recruiting
    - Institute for Allergy and Asthma Research Berlin, IAAB_Site n. 276008
    - Principal Investigator:
      
      Matthias Kruell
  - Berlin, Germany, 12203
    - Recruiting
    - MECS research GmbH_Site 276011
    - Principal Investigator:
      
      Thomas Schultz
  - Cottbus, Germany, 03050
    - Recruiting
    - MECS Cottbus GmbH_Site n. 276007
    - Principal Investigator:
      
      Iwona Cwiek
  - Delitzsch, Germany, 04509
    - Recruiting
    - Klifeck GmbH_Site n. 276002
    - Principal Investigator:
      
      Gerald Eckhardt
  - Düsseldorf, Germany, 40217
    - Recruiting
    - Schwerpunktpraxis Lungen- und Bronchialheilkunde Allergologie und Schlafmedizin_Site n. 276009
    - Principal Investigator:
      
      Ulrike Neise
  - Hamburg, Germany, 20095
    - Recruiting
    - Velocity Clinical Research Germany GmbH_Site n. 276019
    - Principal Investigator:
      
      Anastasia Kelidou
  - Ibbenbueren, Germany, 49477
    - Recruiting
    - Gemeinschaftspraxis für Pneumologie, Allergologie und Schlafmedizin_Site n. 276012
    - Principal Investigator:
      
      Christoph Stolpe
  - Leipzig, Germany, 04157
    - Recruiting
    - Pulmologische Praxis Dr. Brunner_Site n. 276013
    - Principal Investigator:
      
      Falk Brunner
  - Leipzig, Germany, 04177
    - Recruiting
    - Velocity Clinical Research Leipzig GmbH_Site n. 276018
    - Principal Investigator:
      
      Thomas Muller
  - Leipzig, Germany, 04299
    - Recruiting
    - Practice for pneumology and allergology_Site n. 276021
    - Principal Investigator:
      
      Gerhard Hoheisel
  - Leipzig, Germany, 04347
    - Recruiting
    - POIS Sachsen_Site n. 276001
    - Principal Investigator:
      
      Juliana Brode
  - Marburg, Germany, 35037
    - Recruiting
    - Zentrum Fur Ambulante Pneumologische Forschung Mbg GbR_Site n. 276015
    - Principal Investigator:
      
      Lukas Jerrentrup
  - Neu-Isenburg, Germany, 63263
    - Recruiting
    - Ballenberger, Freytag, Wenisch - Institut fuer Klinische Forschung GmbH_Site n. 276014
    - Principal Investigator:
      
      Sabine Ballenberger
Hungary
- - Békéscsaba, Hungary, 5600
    - Recruiting
    - Trial Pharma Kft. - TPKFT_Site n. 348011
    - Principal Investigator:
      
      Ibolya Vendrey-Laczo
  - Edelény, Hungary, 3780
    - Recruiting
    - Edelenyi Koch Robert Korhaz Es Rendelointezet_Site n. 348013
    - Principal Investigator:
      
      Melinda Szabo
  - Hajdúnánás, Hungary, 4080
    - Recruiting
    - Szalay Janos Rendelointezet_Site n. 348006
    - Principal Investigator:
      
      Aniko Kurucz
  - Hatvan, Hungary, H-3000
    - Recruiting
    - BKS Research Kft._Site n. 348001
    - Principal Investigator:
      
      Agota Bencze
  - Monor, Hungary, 2200
    - Recruiting
    - Bajcsy-Zsilinszky Korhaz es Rendelointezet_Site n. 348002
    - Principal Investigator:
      
      Zoltan Bende Bende
  - Nyíregyháza, Hungary, 4400
    - Recruiting
    - Revamed Kft._Site n. 348004
    - Principal Investigator:
      
      Valeria Csajbok
  - Nyíregyháza, Hungary, 4481
    - Recruiting
    - Simplex Kft._Site n. 348007
    - Principal Investigator:
      
      Tamas Kardos
  - Szeged, Hungary, 6726
    - Recruiting
    - Trial Pharma Kft. - Szeged_Site n. 348010
    - Principal Investigator:
      
      Gyongyver Szaloky
  - Szolnok, Hungary, 5000
    - Recruiting
    - Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet_Site n. 348003
    - Principal Investigator:
      
      Margit Biro
  - Szombathely, Hungary, 9700
    - Recruiting
    - Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz_Site n. 348005
    - Principal Investigator:
      
      Zsuzsanna Cseke
  - Szombathely, Hungary, H-9700
    - Recruiting
    - K&B Sleepmed Kft_Site n. 348008
    - Principal Investigator:
      
      Krisztina Hajdu
Latvia
- - Jūrmala, Latvia, 2015
    - Recruiting
    - VCA Polyclinic DUBULTI_Site n. 428006
    - Principal Investigator:
      
      Natalija Visocka
  - Riga, Latvia, 1001
    - Recruiting
    - Riga 1st Hospital_Site n. 428003
    - Principal Investigator:
      
      Ilze Reinholde
  - Riga, Latvia, 1002
    - Recruiting
    - Paula Stradiņa Klīniskā Universitātes Slimnīca_Site n. 428001
    - Principal Investigator:
      
      Aurika Babjoniseva
  - Riga, Latvia, 1010
    - Recruiting
    - Consilium Medicum_Site n. 428002
    - Principal Investigator:
      
      Maris Bukovskis
  - Riga, Latvia, 1038
    - Recruiting
    - SIA Rigas Austrumu Kliniska Universitates Slimnica - Gailezers_Site n. 428005
    - Principal Investigator:
      
      Inga Vikmane
Mexico
- - Durango, Mexico, 34000
    - Recruiting
    - CIAID - Centro de Investigacion y Atencion Integral Durango, S.C._Site n. 484006
    - Principal Investigator:
      
      Ricardo Alberto Ramirez Terrones
  - Mexico City, Mexico, 14050
    - Recruiting
    - Centro Respiratorio de México_Site n. 484008
    - Principal Investigator:
      
      Raul Humberto Sansores Martínez
  - Mérida, Mexico, 97130
    - Recruiting
    - Centro Mexicano de Desarrollo de Estudios Clinicos (CEMDEC SA)_Site n. 484010
    - Principal Investigator:
      
      Matilde Damian-Hernandez
Romania
- - Bacau, Romania, 600252
    - Recruiting
    - Spitalul de Pneumoftiziologie Bacau_Site n. 642014
    - Principal Investigator:
      
      Dragos Gabriel Ungureanu
  - Bragadiru, Romania, 077025
    - Recruiting
    - ANGISAN GRUP SRL_Site n. 642005
    - Principal Investigator:
      
      Angelica Savu
  - Brasov, Romania, 500051
    - Recruiting
    - Pneumo Bronho Med_Site n. 642002
    - Principal Investigator:
      
      Ionela Iovan
  - Brasov, Romania, 500051
    - Recruiting
    - Theramed Healthcare S.R.L._Site n. 642001
    - Principal Investigator:
      
      Ioana Agache
  - Bucharest, Romania, 020125
    - Recruiting
    - Spitalul Clinic Colentina_Site n. 642010
    - Principal Investigator:
      
      Poliana Leru
  - Bucharest, Romania, 10243
    - Recruiting
    - Spitalul Clinic Nr.1 Cai Ferate Witing_Site n. 642008
    - Principal Investigator:
      
      Ana Maria Trailescu
  - Bucharest, Romania, 14461
    - Recruiting
    - Delta Health Care S.R.L._Site n. 642006
    - Principal Investigator:
      
      Veronica Surlea
  - Craiova, Romania, 200515
    - Recruiting
    - Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Dr. Victor Babeș" Craiova_Site n. 642003
    - Principal Investigator:
      
      Dragos Nicolosu
  - Deva, Romania, 330084
    - Recruiting
    - SC Medical Center SRL_Site n. 642013
    - Principal Investigator:
      
      Ioan Petrui
  - Oradea, Romania, 410290
    - Recruiting
    - Spital De Pneumologie Dr. Lavinia Davidescu S.R.L._Site n. 642009
    - Principal Investigator:
      
      Cristian Stefan Mago
  - Timișoara, Romania, 300041
    - Recruiting
    - SC M-Profilaxis SRL_Site n. 642004
    - Principal Investigator:
      
      Carmen Panaitescu
  - Timișoara, Romania, 300298
    - Recruiting
    - Neoclinic Concept S.R.L._Site n. 642011
    - Principal Investigator:
      
      Stefan Mihaicuta
  - Timișoara, Romania, 300310
    - Recruiting
    - Spitalul Clinic de Boli Infecţioase si Pneumofiziologie "Dr. Victor Babes"_Site n. 642007
    - Principal Investigator:
      
      Cristian Oancea
Serbia
- - Belgrade, Serbia, 11000
    - Recruiting
    - KBC "Dr Dragiša Mišović-Dedinje"_Site n. 688004
    - Principal Investigator:
      
      Vesna Djuric
  - Belgrade, Serbia, 11000
    - Recruiting
    - Klinicki Centar Srbije (KCS) - Klinika za Pulmologiju_Site n. 688009
    - Principal Investigator:
      
      Ana Samardzic
  - Belgrade, Serbia, 11120
    - Recruiting
    - Municipal Institute for Lung Disease and Tuberculosis_Site n. 688010
    - Principal Investigator:
      
      Gorana Sovljanski
  - Kragujevac, Serbia, 34000
    - Recruiting
    - Klinički Centar Kragujevac_Site n. 688007
    - Principal Investigator:
      
      Slavica Mojsilovic
  - Kragujevac, Serbia, 34111
    - Recruiting
    - Klinički Centar Kragujevac_Site n. 688003
    - Principal Investigator:
      
      Ivan Cekerevac
  - Niš, Serbia, 18000
    - Recruiting
    - Clinical Centre of Nis_Site n. 688011
    - Principal Investigator:
      
      Ivana Stankovic
  - Niš, Serbia, 18101
    - Recruiting
    - Institute for Lung Diseases and Tuberculosis - Nis_Site n. 688001
    - Principal Investigator:
      
      Sasa Jovanovic
  - Novi Sad, Serbia, 21000
    - Recruiting
    - Institute for Pulmonary Diseases of Vojvodina_Site n. 688006
    - Principal Investigator:
      
      Miroslav Ilic
  - Sremska Mitrovica, Serbia, 21208
    - Recruiting
    - Institute for Pulmonary Diseases of Vojvodina_Site n. 688012
    - Principal Investigator:
      
      Violeta Kolarov
  - Užice, Serbia, 31000
    - Recruiting
    - Zdravstveni Centar Užice_Site n. 688008
    - Principal Investigator:
      
      Zorica Radojevic
  - Valjevo, Serbia, 14000
    - Recruiting
    - Health Center Valjevo, General Hospital Valjevo_Site n. 688002
    - Principal Investigator:
      
      Dejan Sofronic
Slovakia
- - Bardejov, Slovakia, 085 01
    - Recruiting
    - Alian, s.r.o._Site n. 703001
    - Principal Investigator:
      
      Maria Dzupinova
  - Levice, Slovakia, 934 01
    - Recruiting
    - DANIMED, spol. s r.o._Site n. 703003
    - Principal Investigator:
      
      Daniela Hasicova
  - Spišská Nová Ves, Slovakia, 052 01
    - Recruiting
    - Pľúcna Ambulancia Hrebenár, s.r.o._Site n. 703002
    - Principal Investigator:
      
      Slavomir Hrebenar
South Africa
- - Bellville, South Africa, 7530
    - Recruiting
    - Tiervlei Trial Centre_Site n. 710007
    - Principal Investigator:
      
      Karla Morrison
  - Benoni, South Africa, 1501
    - Recruiting
    - Worthwhile Clinical Trials_Site n. 710003
    - Principal Investigator:
      
      Nazreen Jeewa Hussen
  - Bloemfontein, South Africa, 9301
    - Recruiting
    - IATROS International_Site n. 710008
    - Principal Investigator:
      
      Nyda Fourie
  - Cape Town, South Africa, 7530
    - Recruiting
    - Task Applied Science (TASK) - Central Location_Site n. 710015
    - Principal Investigator:
      
      Karla Morrison
  - Chatsworth, South Africa, 4092
    - Recruiting
    - Precise Clinical Solutions_Site n. 710004
    - Principal Investigator:
      
      Visvakuren Naidoo
  - Durban, South Africa, 4001
    - Recruiting
    - Synapta Clinical Research Centre_Site n. 710006
    - Principal Investigator:
      
      Farzana Hoosen
  - George, South Africa, 6529
    - Recruiting
    - TASK Eden_Site n. 710001
    - Principal Investigator:
      
      Suzanne Staples
  - KwaZulu, South Africa, 3201
    - Recruiting
    - Meditrial_Site n. 710002
    - Principal Investigator:
      
      Jessica Fryer
  - Middelburg, South Africa, 1050
    - Recruiting
    - Mzansi Ethical Research Centre (MERC)_Site n. 710005
    - Principal Investigator:
      
      Mohammed Siddique Tayob
  - Pretoria, South Africa, 157
    - Recruiting
    - Johese Clinical Research - Centurion_Site 710010
    - Principal Investigator:
      
      Johannes Giessing
  - Pretoria, South Africa, 184
    - Recruiting
    - Botho Ke Bontle Healthcare Pty LTD_Site n. 710012
    - Principal Investigator:
      
      Salphy Mokgadi Mogashoa
  - Pretoria, South Africa, 83
    - Recruiting
    - Global Clinical Trials Pty Ltd_Site n. 710011
    - Principal Investigator:
      
      Larisha Pillay-Ramaya
  - Welkom, South Africa, 9460
    - Recruiting
    - Welkom Clinical Trial Centre_Site n. 710013
    - Principal Investigator:
      
      Yacoob Vahed
Ukraine
- - Chernivtsi, Ukraine, 58000
    - Recruiting
    - Chernivtsi Regional Clinical Hospital_Site n. 804006
    - Principal Investigator:
      
      Svitlana Kovalenko
  - Dnipro, Ukraine, 49006
    - Recruiting
    - Clinical Hospital of Emergency Medical Care of the Dnipro City Council Allergy Center_Site n. 804014
    - Principal Investigator:
      
      Evgeniya Dytyatkovska
  - Ivano-Frankivsk, Ukraine, 76012
    - Recruiting
    - Ivano-Frankivsk City Clinical Hospital No. 1_Site n. 804003
    - Principal Investigator:
      
      Sergiy Fedorov
  - Ivano-Frankivsk, Ukraine, 76018
    - Recruiting
    - The Ivano-Frankivsk National Medical Univeristy_Site n. 804004
    - Principal Investigator:
      
      Vira Myhovych
  - Ivano-Frankivsk, Ukraine, 76019
    - Recruiting
    - Regional Centre of Phthisiology and Pulmonology - Ivano-Frankivsk Regional Council_Site n. 804009
    - Principal Investigator:
      
      Mykola Ostrovskyy
  - Kyiv, Ukraine, 02002
    - Recruiting
    - Medical Center "ARTES MEDICUM" LLC_Site n. 804002
    - Principal Investigator:
      
      Dmytro Dobrianskyi
  - Kyiv, Ukraine, 03038
    - Recruiting
    - National Scientific Center of Phthisiatry Pulmonology and Allergology after F.G. Yanovsky_Site n.804010
    - Principal Investigator:
      
      Nataliia Prymushko
  - Kyiv, Ukraine, 04114
    - Recruiting
    - Institute of Gerontology im D. F. Chebotarova NAMS of Ukraine_Site n. 804001
    - Principal Investigator:
      
      Ervin Asanov
  - Kyiv, Ukraine, 3049
    - Recruiting
    - Kyiv Railway Clinical Hospital No. 2 of Branch "Healthcare Center" of the PJSC "Ukrainian Railway"_Site n.804013
    - Principal Investigator:
      
      Bogdan Gundertaylo
  - Kyiv, Ukraine, 3680
    - Recruiting
    - National Scientific Center of Phthisiatry Pulmonology and Allergology after F.G. Yanovsky_Site n. 804016
    - Principal Investigator:
      
      Volodymyr Gavrysyuk
  - Odesa, Ukraine, 65025
    - Recruiting
    - Odesa Regional Clinical Hospital of Odesa Regional Council_Site n. 804008
    - Principal Investigator:
      
      Yuliia Novosolova
  - Poltava, Ukraine, 36039
    - Recruiting
    - Limited Liability Company Medical and Diagnostic Center "Medion"_Site n. 804007
    - Principal Investigator:
      
      Ivan Kryvoruchko
  - Vinnytsia, Ukraine, 21029
    - Recruiting
    - University Clinic of Vinnytsia National Medical University named after M.I. Pirogova_Site n. 804011
    - Principal Investigator:
      
      Sergii Shevchuk
  - Vinnytsia, Ukraine, 21029
    - Recruiting
    - Vinnytsia City Clinical Hospital No. 1_Site n. 804005
    - Principal Investigator:
      
      Tetyana Konstantynovych
  - Vinnytsia, Ukraine, 21029
    - Recruiting
    - Vinnytsia City Clinical Hospital No. 1_Site n. 804012
    - Principal Investigator:
      
      Nataliya Slepchenko
United Kingdom
- - Belfast, United Kingdom, BT2 8BG
    - Recruiting
    - Ormeau Clinical Trials Ltd._Site n. 826005
    - Principal Investigator:
      
      Damien McNally
  - Bristol, United Kingdom, BS10 5NB
    - Recruiting
    - North Bristol NHS Trust - Southmead Hospital Bristol_Site n. 826010
    - Principal Investigator:
      
      James Dodd
  - Bristol, United Kingdom, BS34 6BQ
    - Recruiting
    - Concord Medical Centre_Site n. 826009
    - Principal Investigator:
      
      James Case
  - Dagenham, United Kingdom, RM9 5QP
    - Recruiting
    - Elpida Trials - Parloes Hub_Site n. 826003
    - Principal Investigator:
      
      Ravali Goriparthi
  - London, United Kingdom, IG1 4HP
    - Recruiting
    - 4 Medical Clinical Solutions (4MCS) - London_Site n. 826004
    - Principal Investigator:
      
      Martin Palin
  - Maidstone, United Kingdom, ME16 9QQ
    - Recruiting
    - Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital_Site n. 826008
    - Principal Investigator:
      
      Tuck-Kay Loke
  - Manchester, United Kingdom, M23 9QZ
    - Recruiting
    - Medicines Evaluation Unit_Site n. 826006
    - Principal Investigator:
      
      Dave Singh
  - Orpington, United Kingdom, BR5 3QG
    - Recruiting
    - Accellacare South London_Site n. 826001
    - Principal Investigator:
      
      Njobuenwnu Hyacienth Amah
  - Portsmouth, United Kingdom, PO6 3LY
    - Recruiting
    - Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital_Site n. 826002
    - Principal Investigator:
      
      Thomas Brown
  - Romsey, United Kingdom, SO51 8EN
    - Recruiting
    - Abbeywell Surgery_Site n. 826007
    - Principal Investigator:
      
      Nicola Lester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years;
Non-smokers, ex-smokers;
Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive;
Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with:
1. low or medium doses of ICS (Inhaled Corticosteroids) alone; or
2. low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination).
Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score <1.5 at screening and at randomisation.
Pre-BD (Bronchodilator) FEV1 >40% and <90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1).
A demonstrated increase in either FEV1 or forced vital capacity of >12% and >200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1).

Exclusion Criteria:

History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk;
Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period ;
Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;
Asthma subjects currently treated with any of the following :
1. High dose ICS;
2. Long-acting muscarinic antagonist (LAMA);
3. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
4. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
5. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening;
Respiratory disorders other than asthma
Lung resection;
Lower respiratory tract infection;
Lung cancer and history of lung cancer;
Subjects with active cancer or a history of cancer (other than lungs) ;
Patients who have clinically significant cardiovascular condition;
Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Quadruple

Arms and Interventions

Participant Group / Arm Participant Group / Arm A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.	Intervention / Treatment Intervention / Treatment A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Treatment: CHF5993 pMDI (Pressurised Metered Dose Inhaler) with HFA-152a BDP (Beclometasone Dipropionate)/FF (Formoterol Fumarate)/GB (Glycopyrronium Bromide) 100/6/12.5 µg	Drug: CHF5993 pMDI with HFA-152a two puffs BID (twice daily)
Active Comparator: Reference Treatment 1: CHF5993 pMDI with HFA-134a BDP/FF/GB 100/6/12.5 µg	Drug: CHF5993 pMDI with HFA-134a two puffs BID
Active Comparator: Reference Treatment 2: CHF718 pMDI with HFA-134a BDP 100 µg	Drug: CHF718 pMDI with HFA-134a two puffs BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (AUC0-4h) on Day 1 Time Frame: Day 1	Day 1
Change from baseline in pre-dose FEV1 on Day 28 Time Frame: Day 28	Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

Principal Investigator: Piotr KUNA, MD, Barlicki University Hospital Medical University of Lodz, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2025

Primary Completion (Estimated)

June 3, 2027

Study Completion (Estimated)

June 3, 2027

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CLI-05993AA9-01
2025-521456-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

NCT07412769

Recruiting

ASMact: Study on Management of Bronchial Asthma

Asthma in Children | Asthma Acute | Asthma Crisis | Asthma Childhood
NCT07629830

Not yet recruiting

Post Exacerbation Asthma Clinic Telecare Intervention to Reduce Recurrent Exacerbations (PACT)

Asthma Attack | Asthma Acute
NCT07261423

Recruiting

Pollution Intervention to Impact Kids Asthma Study (PIKAS)

Asthma Exacerbation | Childhood Asthma | Air Pollution, Risk Reduction Behaviors | Asthma Control
NCT03277170

Withdrawn

Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations

Asthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; Status
NCT03642418

Completed

User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients

Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
NCT07582211

Not yet recruiting

Bilevel Positive Airway Pressure (BPAP) for Severe Asthma

Acute Asthma | Pediatric Asthma | Non-invasive Positive Pressure Ventilation | BiPAP
NCT06377345

Recruiting

Remote Patient Monitoring Solution for Chronic Respiratory Disease Management

Asthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
NCT07600190

Not yet recruiting

Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA) (ARTMA)

Persistent Asthma | Asthma (Diagnosis) | Moderate Asthma Exacerbation
NCT02026492

Completed

Exercise Challenge in a Cold Chamber

Exercise-induced Asthma
NCT07512622

Not yet recruiting

Asthma Ctrl SMART Trial

Asthma in Children | Asthma Chronic

Clinical Trials on CHF5993 pMDI with HFA-152a

NCT06264674

Completed

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). (TRECOS)

Asthma
NCT07546981

Recruiting

Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists (TRICHECO)

Asthma
NCT05875025

Completed

Study to Assess the Effect of the New HFA-152a Propellant on Mucociliary Clearance

Mucociliary Clearance
NCT07645248

Not yet recruiting

A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)

Asthma
NCT03590379

Completed

Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD) (TRI-D)

Chronic Obstructive Pulmonary Disease
NCT06702462

Completed

A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma

Asthma
NCT06506266

Completed

Study of the Effect of HFA-152a and HFA-134a Propellants on Mucociliary Clearance in Healthy Participants

Asthma
NCT00975754

Completed

Lung Deposition Via Different Inhalation Devices

Healthy Volunteers
NCT02287272

Completed

Drug-drug Interaction Study of CHF5993 With Cimetidine

COPD
NCT01136655

Completed

A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy (CHASE 2)

Asthma

Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma (TRECONY)

A Phase II Multinational, Multicentre, Double-blind, Randomised, Active-controlled, 3-way Cross-over Study to Evaluate the Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a Versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in Subjects With Mild to Moderate Asthma

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Asthma

Clinical Trials on CHF5993 pMDI with HFA-152a

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations