RecruitingPhase 2NCT07301736

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

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


Sponsor

Chiesi Farmaceutici S.p.A.

Enrollment

780 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two versions of the same triple-combination inhaler (called CHF5993) for people with mild to moderate asthma — one uses a newer, more environmentally friendly propellant (HFA-152a) and the other uses the standard propellant. Researchers want to confirm that the two versions work equally well. **You may be eligible if...** - You are between 18 and 75 years old - You have had an asthma diagnosis for at least 6 months, diagnosed before age 50 - You are a non-smoker or ex-smoker - You have a BMI between 18 and 35 - You are already on a stable asthma treatment with an inhaled steroid (with or without a long-acting bronchodilator) **You may NOT be eligible if...** - You are a current smoker or have smoked heavily in the past - Your asthma is severe or poorly controlled - You have other significant lung conditions - You have recently had a respiratory infection or asthma attack - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCHF5993 pMDI with HFA-152a

two puffs BID (twice daily)

DRUGCHF5993 pMDI with HFA-134a

two puffs BID

DRUGCHF718 pMDI with HFA-134a

two puffs BID


Locations(167)

Hospital Británico de Buenos Aires_Site n. 032029

Buenos Aires, Argentina

Centro Medico de Enfermedades Respiratorias_Site n. 032002

Buenos Aires, Argentina

Centro Medico Respire_Site n. 032014

Buenos Aires, Argentina

Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018

Buenos Aires, Argentina

Centro de Investigaciones Médicas Mar del Plata_Site n. 032019

Buenos Aires, Argentina

Fundacion CIDEA_Site n. 032009

Buenos Aires, Argentina

Centro Medico Arsema_Site n. 032003

Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)_Site n. 032025

Ciudad Autonoma de Buenos Aire, Argentina

Centro de Medicina Respiratoria - Concepcion del Uruguay_Site n. 032015

Ciudad Autonoma de Buenos Aire, Argentina

CARE - Centro de Alergia y Enfermedades Respiratorias_Site n. 032028

Ciudad Autonoma de Buenos Aire, Argentina

Consultorio Medico Dra. Rivera_Site n. 032012

Ciudad Autonoma de Buenos Aire, Argentina

Fundación Respirar Salud_Site n. 032004

Ciudad Autonoma de Buenos Aire, Argentina

Instituto de Medicina Respiratoria (IMER) - Cordoba_Site n. 032023

Córdoba, Argentina

CePIR_Site n. 032021

La Plata, Argentina

Fundacion Scherbovsky_Site n. 032013

Mendoza, Argentina

Instituto Medico INSARES SA_Site n. 032005

Mendoza, Argentina

Cimro Consultorios Medicos - Centro de Investigacion_Site n. 032006

Mendoza, Argentina

Centro Respiratorio Quilmes_Site n. 032007

Quilmes, Argentina

Fundacion Innovaciencia_Site n. 032017

Rosario, Argentina

Instituto de Especialidades de la Salud Rosario_Site n. 032020

Rosario, Argentina

Instituto Medico de la Fundacion de Estudios Clínicos_Site n. 032001

Rosario, Argentina

Fundacion Grupo Colaborativo Rosario_Site n. 032010

Rosario, Argentina

Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM)_Site n. 032011

San Juan Bautista, Argentina

Centro Modelo de Cardiologia SRL_Site n. 032016

San Miguel de Tucumán, Argentina

Clinica Mayo de UMCB SRL_Site n. 032026

San Miguel de Tucumán, Argentina

Investigaciones en Patologias Respiratorias_Site n. 032022

San Miguel de Tucumán, Argentina

IBAMEDICA_Site n. 032008

Santa Fe, Argentina

University Clinical Centre of the Republic of Srpska - Paprikovac_Site n. 070004

Banja Luka, Bosnia and Herzegovina

Sveti apostol Luka Doboj_Site n. 070005

Doboj, Bosnia and Herzegovina

Dr. Abdulah Nakas General Hospital_Site n. 070007

Sarajevo, Bosnia and Herzegovina

Dr. Abdulah Nakas General Hospital_Site n. 070009

Sarajevo, Bosnia and Herzegovina

Organizational unit Novi Grad_Site n. 070003

Sarajevo, Bosnia and Herzegovina

University Clinical Hospital Mostar_Site n. 07001

Siroki Brijeg, Bosnia and Herzegovina

Opca Bolnica Tesanj_Site n. 070006

Tešanj, Bosnia and Herzegovina

Dr. Mustafa Sehovic Public Medical Center_Site n. 070008

Tuzla, Bosnia and Herzegovina

University Clinical Centre Tuzla_Site n. 070002

Tuzla, Bosnia and Herzegovina

MHAT Sv. Ivan Rilski - Gorna Oryahovitsa_Site n.100017

Gorna Oryahovitsa, Bulgaria

Medical Center Pulmo - 2018_Site n. 100007

Haskovo, Bulgaria

MC ZDRAVE 1 - Kozloduy_Site n. 100009

Kozloduy, Bulgaria

Medical Centre Pratia Clinic EOOD - Lovech_Site n. 100012

Lovech, Bulgaria

Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik EOOD_Site n. 100020

Pernik, Bulgaria

Multiprofile Hospital for Active Treatment "Heart and Brain" EAD_Site n. 100019

Pleven, Bulgaria

Medical Centre ''Unimed'' EOOD_Site n. 100003

Plovdiv, Bulgaria

MHAT "St. Ivan Rilski "- Razgrad_Site 100013

Razgrad, Bulgaria

Outpatient Practice for Specialized Medical Care in Allergology- Dr. Talyat Sali Cholak EOOD_Site 100002

Razgrad, Bulgaria

Re Spiro Medical Center_Site n. 100018

Razgrad, Bulgaria

Medical Center Hermes Ruse_Site n. 100011

Rousse, Bulgaria

SHATPPD "Dr. Dimitar Gramatikov" Ruse EOOD_Site n. 100004

Rousse, Bulgaria

Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski" - Sliven AD_Site n.100014

Sliven, Bulgaria

Medical Center Hera EOOD_Site n. 100006

Sofia, Bulgaria

University First Multiprofile Hospital for Active Treatment - Sofia "St. John the Baptist"_Site n. 100016

Sofia, Bulgaria

Specialized Hospital for Active Treatment Pneumo- Phthisiatric Diseases - Sofia District EOOD_Site n. 100021

Sofia, Bulgaria

Multi-profile hospital for active treatment Lozenets EAD_Site n. 100008

Sofia, Bulgaria

Preventsia 2000 - Medical Centre for Outpatient Medical Care OOD_Site n. 100005

Stara Zagora, Bulgaria

University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD_Site n.100015

Stara Zagora, Bulgaria

Medical Centre New Rehabilitation Centre EOOD_Site n. 100010

Stara Zagora, Bulgaria

Medical Centre Pratia Clinic EOOD - Varna_Site 100001

Varna, Bulgaria

MEDITRIAL, s.r.o._Site n. 203003

Jindřichův Hradec, Czechia

Plicni Ambulance Louny s.r.o - Louny_Site n. 203001

Louny, Czechia

Cefispiro s.r.o_Site n. 203006

Lovosice, Czechia

Nemocnice Mesice - Centrum integrovane onkologicke pece, z.s., Plicni ambulance_Site n. 203004

Měšice, Czechia

MUDr. Ilona Pavlišová sro_Site n. 203007

Miroslav, Czechia

Plicní středisko Teplice s.r.o._Site n. 203002

Teplice, Czechia

PNEUMOLOGIE Varnsdorf_Site n. 203005

Varnsdorf, Czechia

Velocity Clinical Research Germany, Ahrensburg_Site n. 276020

Ahrensburg, Germany

Studienpraxis Berlin-Brandenburg_Site n. 276005

Berlin, Germany

Praxis an der Oper_Site n. 276016

Berlin, Germany

Lungenpraxis Hohenzollerndamm_Site n. 276004

Berlin, Germany

Velocity Clinical Research Germany GmbH_Site 276010

Berlin, Germany

Polikum Institut GmbH_Site n. 276006

Berlin, Germany

Institute for Allergy and Asthma Research Berlin, IAAB_Site n. 276008

Berlin, Germany

MECS research GmbH_Site 276011

Berlin, Germany

MECS Cottbus GmbH_Site n. 276007

Cottbus, Germany

Klifeck GmbH_Site n. 276002

Delitzsch, Germany

Schwerpunktpraxis Lungen- und Bronchialheilkunde Allergologie und Schlafmedizin_Site n. 276009

Düsseldorf, Germany

Velocity Clinical Research Germany GmbH_Site n. 276019

Hamburg, Germany

Gemeinschaftspraxis für Pneumologie, Allergologie und Schlafmedizin_Site n. 276012

Ibbenbueren, Germany

Pulmologische Praxis Dr. Brunner_Site n. 276013

Leipzig, Germany

Velocity Clinical Research Leipzig GmbH_Site n. 276018

Leipzig, Germany

Practice for pneumology and allergology_Site n. 276021

Leipzig, Germany

POIS Sachsen_Site n. 276001

Leipzig, Germany

Zentrum Fur Ambulante Pneumologische Forschung Mbg GbR_Site n. 276015

Marburg, Germany

Ballenberger, Freytag, Wenisch - Institut fuer Klinische Forschung GmbH_Site n. 276014

Neu-Isenburg, Germany

Trial Pharma Kft. - TPKFT_Site n. 348011

Békéscsaba, Hungary

Edelenyi Koch Robert Korhaz Es Rendelointezet_Site n. 348013

Edelény, Hungary

Szalay Janos Rendelointezet_Site n. 348006

Hajdúnánás, Hungary

BKS Research Kft._Site n. 348001

Hatvan, Hungary

Bajcsy-Zsilinszky Korhaz es Rendelointezet_Site n. 348002

Monor, Hungary

Revamed Kft._Site n. 348004

Nyíregyháza, Hungary

Simplex Kft._Site n. 348007

Nyíregyháza, Hungary

Trial Pharma Kft. - Szeged_Site n. 348010

Szeged, Hungary

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet_Site n. 348003

Szolnok, Hungary

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz_Site n. 348005

Szombathely, Hungary

K&B Sleepmed Kft_Site n. 348008

Szombathely, Hungary

VCA Polyclinic DUBULTI_Site n. 428006

Jūrmala, Latvia

Riga 1st Hospital_Site n. 428003

Riga, Latvia

Paula Stradiņa Klīniskā Universitātes Slimnīca_Site n. 428001

Riga, Latvia

Consilium Medicum_Site n. 428002

Riga, Latvia

SIA Rigas Austrumu Kliniska Universitates Slimnica - Gailezers_Site n. 428005

Riga, Latvia

CIAID - Centro de Investigacion y Atencion Integral Durango, S.C._Site n. 484006

Durango, Mexico

Centro Respiratorio de México_Site n. 484008

Mexico City, Mexico

Centro Mexicano de Desarrollo de Estudios Clinicos (CEMDEC SA)_Site n. 484010

Mérida, Mexico

Spitalul de Pneumoftiziologie Bacau_Site n. 642014

Bacau, Romania

ANGISAN GRUP SRL_Site n. 642005

Bragadiru, Romania

Pneumo Bronho Med_Site n. 642002

Brasov, Romania

Theramed Healthcare S.R.L._Site n. 642001

Brasov, Romania

Spitalul Clinic Colentina_Site n. 642010

Bucharest, Romania

Spitalul Clinic Nr.1 Cai Ferate Witing_Site n. 642008

Bucharest, Romania

Delta Health Care S.R.L._Site n. 642006

Bucharest, Romania

Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Dr. Victor Babeș" Craiova_Site n. 642003

Craiova, Romania

SC Medical Center SRL_Site n. 642013

Deva, Romania

Spital De Pneumologie Dr. Lavinia Davidescu S.R.L._Site n. 642009

Oradea, Romania

SC M-Profilaxis SRL_Site n. 642004

Timișoara, Romania

Neoclinic Concept S.R.L._Site n. 642011

Timișoara, Romania

Spitalul Clinic de Boli Infecţioase si Pneumofiziologie "Dr. Victor Babes"_Site n. 642007

Timișoara, Romania

KBC "Dr Dragiša Mišović-Dedinje"_Site n. 688004

Belgrade, Serbia

Klinicki Centar Srbije (KCS) - Klinika za Pulmologiju_Site n. 688009

Belgrade, Serbia

Municipal Institute for Lung Disease and Tuberculosis_Site n. 688010

Belgrade, Serbia

Klinički Centar Kragujevac_Site n. 688007

Kragujevac, Serbia

Klinički Centar Kragujevac_Site n. 688003

Kragujevac, Serbia

Clinical Centre of Nis_Site n. 688011

Niš, Serbia

Institute for Lung Diseases and Tuberculosis - Nis_Site n. 688001

Niš, Serbia

Institute for Pulmonary Diseases of Vojvodina_Site n. 688006

Novi Sad, Serbia

Institute for Pulmonary Diseases of Vojvodina_Site n. 688012

Sremska Mitrovica, Serbia

Zdravstveni Centar Užice_Site n. 688008

Užice, Serbia

Health Center Valjevo, General Hospital Valjevo_Site n. 688002

Valjevo, Serbia

Alian, s.r.o._Site n. 703001

Bardejov, Slovakia

DANIMED, spol. s r.o._Site n. 703003

Levice, Slovakia

Pľúcna Ambulancia Hrebenár, s.r.o._Site n. 703002

Spišská Nová Ves, Slovakia

Tiervlei Trial Centre_Site n. 710007

Bellville, South Africa

Worthwhile Clinical Trials_Site n. 710003

Benoni, South Africa

IATROS International_Site n. 710008

Bloemfontein, South Africa

Task Applied Science (TASK) - Central Location_Site n. 710015

Cape Town, South Africa

Precise Clinical Solutions_Site n. 710004

Chatsworth, South Africa

Synapta Clinical Research Centre_Site n. 710006

Durban, South Africa

TASK Eden_Site n. 710001

George, South Africa

Meditrial_Site n. 710002

KwaZulu, South Africa

Mzansi Ethical Research Centre (MERC)_Site n. 710005

Middelburg, South Africa

Johese Clinical Research - Centurion_Site 710010

Pretoria, South Africa

Botho Ke Bontle Healthcare Pty LTD_Site n. 710012

Pretoria, South Africa

Global Clinical Trials Pty Ltd_Site n. 710011

Pretoria, South Africa

Welkom Clinical Trial Centre_Site n. 710013

Welkom, South Africa

Chernivtsi Regional Clinical Hospital_Site n. 804006

Chernivtsi, Ukraine

Clinical Hospital of Emergency Medical Care of the Dnipro City Council Allergy Center_Site n. 804014

Dnipro, Ukraine

Ivano-Frankivsk City Clinical Hospital No. 1_Site n. 804003

Ivano-Frankivsk, Ukraine

The Ivano-Frankivsk National Medical Univeristy_Site n. 804004

Ivano-Frankivsk, Ukraine

Regional Centre of Phthisiology and Pulmonology - Ivano-Frankivsk Regional Council_Site n. 804009

Ivano-Frankivsk, Ukraine

Medical Center "ARTES MEDICUM" LLC_Site n. 804002

Kyiv, Ukraine

National Scientific Center of Phthisiatry Pulmonology and Allergology after F.G. Yanovsky_Site n.804010

Kyiv, Ukraine

Institute of Gerontology im D. F. Chebotarova NAMS of Ukraine_Site n. 804001

Kyiv, Ukraine

Kyiv Railway Clinical Hospital No. 2 of Branch "Healthcare Center" of the PJSC "Ukrainian Railway"_Site n.804013

Kyiv, Ukraine

National Scientific Center of Phthisiatry Pulmonology and Allergology after F.G. Yanovsky_Site n. 804016

Kyiv, Ukraine

Odesa Regional Clinical Hospital of Odesa Regional Council_Site n. 804008

Odesa, Ukraine

Limited Liability Company Medical and Diagnostic Center "Medion"_Site n. 804007

Poltava, Ukraine

University Clinic of Vinnytsia National Medical University named after M.I. Pirogova_Site n. 804011

Vinnytsia, Ukraine

Vinnytsia City Clinical Hospital No. 1_Site n. 804005

Vinnytsia, Ukraine

Vinnytsia City Clinical Hospital No. 1_Site n. 804012

Vinnytsia, Ukraine

Ormeau Clinical Trials Ltd._Site n. 826005

Belfast, United Kingdom

North Bristol NHS Trust - Southmead Hospital Bristol_Site n. 826010

Bristol, United Kingdom

Concord Medical Centre_Site n. 826009

Bristol, United Kingdom

Elpida Trials - Parloes Hub_Site n. 826003

Dagenham, United Kingdom

4 Medical Clinical Solutions (4MCS) - London_Site n. 826004

London, United Kingdom

Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital_Site n. 826008

Maidstone, United Kingdom

Medicines Evaluation Unit_Site n. 826006

Manchester, United Kingdom

Accellacare South London_Site n. 826001

Orpington, United Kingdom

Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital_Site n. 826002

Portsmouth, United Kingdom

Abbeywell Surgery_Site n. 826007

Romsey, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07301736


Related Trials