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
2 other identifiers
interventional
780
14 countries
167
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Dec 2025
Typical duration for phase_2 asthma
167 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2025
CompletedStudy Start
First participant enrolled
December 17, 2025
CompletedFirst Posted
Study publicly available on registry
December 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 3, 2027
June 25, 2026
June 1, 2026
1.5 years
December 11, 2025
June 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Day 1
Change from baseline in pre-dose FEV1 on Day 28
Day 28
Study Arms (3)
Test Treatment: CHF5993 pMDI (Pressurised Metered Dose Inhaler) with HFA-152a
EXPERIMENTALBDP (Beclometasone Dipropionate)/FF (Formoterol Fumarate)/GB (Glycopyrronium Bromide) 100/6/12.5 µg
Reference Treatment 1: CHF5993 pMDI with HFA-134a
ACTIVE COMPARATORBDP/FF/GB 100/6/12.5 µg
Reference Treatment 2: CHF718 pMDI with HFA-134a
ACTIVE COMPARATORBDP 100 µg
Interventions
two puffs BID (twice daily)
Eligibility Criteria
You may qualify if:
- 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:
- low or medium doses of ICS (Inhaled Corticosteroids) alone; or
- 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).
You may not qualify if:
- 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 :
- High dose ICS;
- Long-acting muscarinic antagonist (LAMA);
- Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
- Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (167)
Hospital Británico de Buenos Aires_Site n. 032029
Buenos Aires, 1275, Argentina
Centro Medico de Enfermedades Respiratorias_Site n. 032002
Buenos Aires, 1602, Argentina
Centro Medico Respire_Site n. 032014
Buenos Aires, 1646, Argentina
Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018
Buenos Aires, 1887, Argentina
Centro de Investigaciones Médicas Mar del Plata_Site n. 032019
Buenos Aires, 7600, Argentina
Fundacion CIDEA_Site n. 032009
Buenos Aires, C1121ABE, Argentina
Centro Medico Arsema_Site n. 032003
Buenos Aires, C1427BCR, Argentina
Centro de Investigaciones Metabólicas (CINME)_Site n. 032025
Ciudad Autonoma de Buenos Aire, 1056ABJ, Argentina
Centro de Medicina Respiratoria - Concepcion del Uruguay_Site n. 032015
Ciudad Autonoma de Buenos Aire, 1056ABJ, Argentina
CARE - Centro de Alergia y Enfermedades Respiratorias_Site n. 032028
Ciudad Autonoma de Buenos Aire, 1414, Argentina
Consultorio Medico Dra. Rivera_Site n. 032012
Ciudad Autonoma de Buenos Aire, 1426, Argentina
Fundación Respirar Salud_Site n. 032004
Ciudad Autonoma de Buenos Aire, 1426, Argentina
Instituto de Medicina Respiratoria (IMER) - Cordoba_Site n. 032023
Córdoba, X5003DCE, Argentina
CePIR_Site n. 032021
La Plata, 1900, Argentina
Fundacion Scherbovsky_Site n. 032013
Mendoza, 5500, Argentina
Instituto Medico INSARES SA_Site n. 032005
Mendoza, 5500, Argentina
Cimro Consultorios Medicos - Centro de Investigacion_Site n. 032006
Mendoza, 5600, Argentina
Centro Respiratorio Quilmes_Site n. 032007
Quilmes, 1878, Argentina
Fundacion Innovaciencia_Site n. 032017
Rosario, 2000, Argentina
Instituto de Especialidades de la Salud Rosario_Site n. 032020
Rosario, 2000, Argentina
Instituto Medico de la Fundacion de Estudios Clínicos_Site n. 032001
Rosario, 2000, Argentina
Fundacion Grupo Colaborativo Rosario_Site n. 032010
Rosario, 2132, Argentina
Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM)_Site n. 032011
San Juan Bautista, 1888, Argentina
Centro Modelo de Cardiologia SRL_Site n. 032016
San Miguel de Tucumán, 4000, Argentina
Clinica Mayo de UMCB SRL_Site n. 032026
San Miguel de Tucumán, 4000, Argentina
Investigaciones en Patologias Respiratorias_Site n. 032022
San Miguel de Tucumán, T4000, Argentina
IBAMEDICA_Site n. 032008
Santa Fe, 3000, Argentina
University Clinical Centre of the Republic of Srpska - Paprikovac_Site n. 070004
Banja Luka, 78000, Bosnia and Herzegovina
Sveti apostol Luka Doboj_Site n. 070005
Doboj, 74000, Bosnia and Herzegovina
Dr. Abdulah Nakas General Hospital_Site n. 070007
Sarajevo, 71000, Bosnia and Herzegovina
Dr. Abdulah Nakas General Hospital_Site n. 070009
Sarajevo, 71000, Bosnia and Herzegovina
Organizational unit Novi Grad_Site n. 070003
Sarajevo, 71000, Bosnia and Herzegovina
University Clinical Hospital Mostar_Site n. 07001
Siroki Brijeg, 88226, Bosnia and Herzegovina
Opca Bolnica Tesanj_Site n. 070006
Tešanj, 74260, Bosnia and Herzegovina
Dr. Mustafa Sehovic Public Medical Center_Site n. 070008
Tuzla, 75000, Bosnia and Herzegovina
University Clinical Centre Tuzla_Site n. 070002
Tuzla, 75000, Bosnia and Herzegovina
MHAT Sv. Ivan Rilski - Gorna Oryahovitsa_Site n.100017
Gorna Oryahovitsa, 5100, Bulgaria
Medical Center Pulmo - 2018_Site n. 100007
Haskovo, 6300, Bulgaria
MC ZDRAVE 1 - Kozloduy_Site n. 100009
Kozloduy, 3320, Bulgaria
Medical Centre Pratia Clinic EOOD - Lovech_Site n. 100012
Lovech, 5500, Bulgaria
Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik EOOD_Site n. 100020
Pernik, 2300, Bulgaria
Multiprofile Hospital for Active Treatment "Heart and Brain" EAD_Site n. 100019
Pleven, 5804, Bulgaria
Medical Centre ''Unimed'' EOOD_Site n. 100003
Plovdiv, 4000, Bulgaria
MHAT "St. Ivan Rilski "- Razgrad_Site 100013
Razgrad, 7200, Bulgaria
Outpatient Practice for Specialized Medical Care in Allergology- Dr. Talyat Sali Cholak EOOD_Site 100002
Razgrad, 7200, Bulgaria
Re Spiro Medical Center_Site n. 100018
Razgrad, 7200, Bulgaria
Medical Center Hermes Ruse_Site n. 100011
Rousse, 7002, Bulgaria
SHATPPD "Dr. Dimitar Gramatikov" Ruse EOOD_Site n. 100004
Rousse, 7002, Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski" - Sliven AD_Site n.100014
Sliven, 8800, Bulgaria
Medical Center Hera EOOD_Site n. 100006
Sofia, 1000, Bulgaria
University First Multiprofile Hospital for Active Treatment - Sofia "St. John the Baptist"_Site n. 100016
Sofia, 1142, Bulgaria
Specialized Hospital for Active Treatment Pneumo- Phthisiatric Diseases - Sofia District EOOD_Site n. 100021
Sofia, 1202, Bulgaria
Multi-profile hospital for active treatment Lozenets EAD_Site n. 100008
Sofia, 1407, Bulgaria
Preventsia 2000 - Medical Centre for Outpatient Medical Care OOD_Site n. 100005
Stara Zagora, 6000, Bulgaria
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD_Site n.100015
Stara Zagora, 6000, Bulgaria
Medical Centre New Rehabilitation Centre EOOD_Site n. 100010
Stara Zagora, 6001, Bulgaria
Medical Centre Pratia Clinic EOOD - Varna_Site 100001
Varna, 9020, Bulgaria
MEDITRIAL, s.r.o._Site n. 203003
Jindřichův Hradec, 377 01, Czechia
Plicni Ambulance Louny s.r.o - Louny_Site n. 203001
Louny, 44001, Czechia
Cefispiro s.r.o_Site n. 203006
Lovosice, 41002, Czechia
Nemocnice Mesice - Centrum integrovane onkologicke pece, z.s., Plicni ambulance_Site n. 203004
Měšice, 25064, Czechia
MUDr. Ilona Pavlišová sro_Site n. 203007
Miroslav, 67271, Czechia
Plicní středisko Teplice s.r.o._Site n. 203002
Teplice, 41501, Czechia
PNEUMOLOGIE Varnsdorf_Site n. 203005
Varnsdorf, 40747, Czechia
Velocity Clinical Research Germany, Ahrensburg_Site n. 276020
Ahrensburg, 22926, Germany
Studienpraxis Berlin-Brandenburg_Site n. 276005
Berlin, 10119, Germany
Praxis an der Oper_Site n. 276016
Berlin, 10625, Germany
Lungenpraxis Hohenzollerndamm_Site n. 276004
Berlin, 10717, Germany
Velocity Clinical Research Germany GmbH_Site 276010
Berlin, 10787, Germany
Polikum Institut GmbH_Site n. 276006
Berlin, 12157, Germany
Institute for Allergy and Asthma Research Berlin, IAAB_Site n. 276008
Berlin, 12159, Germany
MECS research GmbH_Site 276011
Berlin, 12203, Germany
MECS Cottbus GmbH_Site n. 276007
Cottbus, 03050, Germany
Klifeck GmbH_Site n. 276002
Delitzsch, 04509, Germany
Schwerpunktpraxis Lungen- und Bronchialheilkunde Allergologie und Schlafmedizin_Site n. 276009
Düsseldorf, 40217, Germany
Velocity Clinical Research Germany GmbH_Site n. 276019
Hamburg, 20095, Germany
Gemeinschaftspraxis für Pneumologie, Allergologie und Schlafmedizin_Site n. 276012
Ibbenbueren, 49477, Germany
Pulmologische Praxis Dr. Brunner_Site n. 276013
Leipzig, 04157, Germany
Velocity Clinical Research Leipzig GmbH_Site n. 276018
Leipzig, 04177, Germany
Practice for pneumology and allergology_Site n. 276021
Leipzig, 04299, Germany
POIS Sachsen_Site n. 276001
Leipzig, 04347, Germany
Zentrum Fur Ambulante Pneumologische Forschung Mbg GbR_Site n. 276015
Marburg, 35037, Germany
Ballenberger, Freytag, Wenisch - Institut fuer Klinische Forschung GmbH_Site n. 276014
Neu-Isenburg, 63263, Germany
Trial Pharma Kft. - TPKFT_Site n. 348011
Békéscsaba, 5600, Hungary
Edelenyi Koch Robert Korhaz Es Rendelointezet_Site n. 348013
Edelény, 3780, Hungary
Szalay Janos Rendelointezet_Site n. 348006
Hajdúnánás, 4080, Hungary
BKS Research Kft._Site n. 348001
Hatvan, H-3000, Hungary
Bajcsy-Zsilinszky Korhaz es Rendelointezet_Site n. 348002
Monor, 2200, Hungary
Revamed Kft._Site n. 348004
Nyíregyháza, 4400, Hungary
Simplex Kft._Site n. 348007
Nyíregyháza, 4481, Hungary
Trial Pharma Kft. - Szeged_Site n. 348010
Szeged, 6726, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet_Site n. 348003
Szolnok, 5000, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz_Site n. 348005
Szombathely, 9700, Hungary
K&B Sleepmed Kft_Site n. 348008
Szombathely, H-9700, Hungary
VCA Polyclinic DUBULTI_Site n. 428006
Jūrmala, 2015, Latvia
Riga 1st Hospital_Site n. 428003
Riga, 1001, Latvia
Paula Stradiņa Klīniskā Universitātes Slimnīca_Site n. 428001
Riga, 1002, Latvia
Consilium Medicum_Site n. 428002
Riga, 1010, Latvia
SIA Rigas Austrumu Kliniska Universitates Slimnica - Gailezers_Site n. 428005
Riga, 1038, Latvia
CIAID - Centro de Investigacion y Atencion Integral Durango, S.C._Site n. 484006
Durango, 34000, Mexico
Centro Respiratorio de México_Site n. 484008
Mexico City, 14050, Mexico
Centro Mexicano de Desarrollo de Estudios Clinicos (CEMDEC SA)_Site n. 484010
Mérida, 97130, Mexico
Spitalul de Pneumoftiziologie Bacau_Site n. 642014
Bacau, 600252, Romania
ANGISAN GRUP SRL_Site n. 642005
Bragadiru, 077025, Romania
Pneumo Bronho Med_Site n. 642002
Brasov, 500051, Romania
Theramed Healthcare S.R.L._Site n. 642001
Brasov, 500051, Romania
Spitalul Clinic Colentina_Site n. 642010
Bucharest, 020125, Romania
Spitalul Clinic Nr.1 Cai Ferate Witing_Site n. 642008
Bucharest, 10243, Romania
Delta Health Care S.R.L._Site n. 642006
Bucharest, 14461, Romania
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Dr. Victor Babeș" Craiova_Site n. 642003
Craiova, 200515, Romania
SC Medical Center SRL_Site n. 642013
Deva, 330084, Romania
Spital De Pneumologie Dr. Lavinia Davidescu S.R.L._Site n. 642009
Oradea, 410290, Romania
SC M-Profilaxis SRL_Site n. 642004
Timișoara, 300041, Romania
Neoclinic Concept S.R.L._Site n. 642011
Timișoara, 300298, Romania
Spitalul Clinic de Boli Infecţioase si Pneumofiziologie "Dr. Victor Babes"_Site n. 642007
Timișoara, 300310, Romania
KBC "Dr Dragiša Mišović-Dedinje"_Site n. 688004
Belgrade, 11000, Serbia
Klinicki Centar Srbije (KCS) - Klinika za Pulmologiju_Site n. 688009
Belgrade, 11000, Serbia
Municipal Institute for Lung Disease and Tuberculosis_Site n. 688010
Belgrade, 11120, Serbia
Klinički Centar Kragujevac_Site n. 688007
Kragujevac, 34000, Serbia
Klinički Centar Kragujevac_Site n. 688003
Kragujevac, 34111, Serbia
Clinical Centre of Nis_Site n. 688011
Niš, 18000, Serbia
Institute for Lung Diseases and Tuberculosis - Nis_Site n. 688001
Niš, 18101, Serbia
Institute for Pulmonary Diseases of Vojvodina_Site n. 688006
Novi Sad, 21000, Serbia
Institute for Pulmonary Diseases of Vojvodina_Site n. 688012
Sremska Mitrovica, 21208, Serbia
Zdravstveni Centar Užice_Site n. 688008
Užice, 31000, Serbia
Health Center Valjevo, General Hospital Valjevo_Site n. 688002
Valjevo, 14000, Serbia
Alian, s.r.o._Site n. 703001
Bardejov, 085 01, Slovakia
DANIMED, spol. s r.o._Site n. 703003
Levice, 934 01, Slovakia
Pľúcna Ambulancia Hrebenár, s.r.o._Site n. 703002
Spišská Nová Ves, 052 01, Slovakia
Tiervlei Trial Centre_Site n. 710007
Bellville, 7530, South Africa
Worthwhile Clinical Trials_Site n. 710003
Benoni, 1501, South Africa
IATROS International_Site n. 710008
Bloemfontein, 9301, South Africa
Task Applied Science (TASK) - Central Location_Site n. 710015
Cape Town, 7530, South Africa
Precise Clinical Solutions_Site n. 710004
Chatsworth, 4092, South Africa
Synapta Clinical Research Centre_Site n. 710006
Durban, 4001, South Africa
TASK Eden_Site n. 710001
George, 6529, South Africa
Meditrial_Site n. 710002
KwaZulu, 3201, South Africa
Mzansi Ethical Research Centre (MERC)_Site n. 710005
Middelburg, 1050, South Africa
Johese Clinical Research - Centurion_Site 710010
Pretoria, 157, South Africa
Botho Ke Bontle Healthcare Pty LTD_Site n. 710012
Pretoria, 184, South Africa
Global Clinical Trials Pty Ltd_Site n. 710011
Pretoria, 83, South Africa
Welkom Clinical Trial Centre_Site n. 710013
Welkom, 9460, South Africa
Chernivtsi Regional Clinical Hospital_Site n. 804006
Chernivtsi, 58000, Ukraine
Clinical Hospital of Emergency Medical Care of the Dnipro City Council Allergy Center_Site n. 804014
Dnipro, 49006, Ukraine
Ivano-Frankivsk City Clinical Hospital No. 1_Site n. 804003
Ivano-Frankivsk, 76012, Ukraine
The Ivano-Frankivsk National Medical Univeristy_Site n. 804004
Ivano-Frankivsk, 76018, Ukraine
Regional Centre of Phthisiology and Pulmonology - Ivano-Frankivsk Regional Council_Site n. 804009
Ivano-Frankivsk, 76019, Ukraine
Medical Center "ARTES MEDICUM" LLC_Site n. 804002
Kyiv, 02002, Ukraine
National Scientific Center of Phthisiatry Pulmonology and Allergology after F.G. Yanovsky_Site n.804010
Kyiv, 03038, Ukraine
Institute of Gerontology im D. F. Chebotarova NAMS of Ukraine_Site n. 804001
Kyiv, 04114, Ukraine
Kyiv Railway Clinical Hospital No. 2 of Branch "Healthcare Center" of the PJSC "Ukrainian Railway"_Site n.804013
Kyiv, 3049, Ukraine
National Scientific Center of Phthisiatry Pulmonology and Allergology after F.G. Yanovsky_Site n. 804016
Kyiv, 3680, Ukraine
Odesa Regional Clinical Hospital of Odesa Regional Council_Site n. 804008
Odesa, 65025, Ukraine
Limited Liability Company Medical and Diagnostic Center "Medion"_Site n. 804007
Poltava, 36039, Ukraine
University Clinic of Vinnytsia National Medical University named after M.I. Pirogova_Site n. 804011
Vinnytsia, 21029, Ukraine
Vinnytsia City Clinical Hospital No. 1_Site n. 804005
Vinnytsia, 21029, Ukraine
Vinnytsia City Clinical Hospital No. 1_Site n. 804012
Vinnytsia, 21029, Ukraine
Ormeau Clinical Trials Ltd._Site n. 826005
Belfast, BT2 8BG, United Kingdom
North Bristol NHS Trust - Southmead Hospital Bristol_Site n. 826010
Bristol, BS10 5NB, United Kingdom
Concord Medical Centre_Site n. 826009
Bristol, BS34 6BQ, United Kingdom
Elpida Trials - Parloes Hub_Site n. 826003
Dagenham, RM9 5QP, United Kingdom
4 Medical Clinical Solutions (4MCS) - London_Site n. 826004
London, IG1 4HP, United Kingdom
Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital_Site n. 826008
Maidstone, ME16 9QQ, United Kingdom
Medicines Evaluation Unit_Site n. 826006
Manchester, M23 9QZ, United Kingdom
Accellacare South London_Site n. 826001
Orpington, BR5 3QG, United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital_Site n. 826002
Portsmouth, PO6 3LY, United Kingdom
Abbeywell Surgery_Site n. 826007
Romsey, SO51 8EN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piotr KUNA, MD
Barlicki University Hospital Medical University of Lodz, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2025
First Posted
December 24, 2025
Study Start
December 17, 2025
Primary Completion (Estimated)
June 3, 2027
Study Completion (Estimated)
June 3, 2027
Last Updated
June 25, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share