AzTrials
AzTrials

AsthmaPhase 2TRECONYNCT07301736

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

A Phase 2 study testing CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a and CHF718 pMDI with HFA-134a in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 167 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a and CHF718 pMDI with HFA-134a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
780 participants
Where
167 sitesin 14 countries
Study dates
17 Dec 2025to 3 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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).

Who cannot join

  • 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);
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  • 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;
  • Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation;

Trial locations and contacts

167 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Chiesi Clinical Trial Info Chiesi Clinical Trials contact

+39 0521 2791

clinicaltrials_info@chiesi.com

167 sites in 14 countries

Argentina27 sites, 27 recruiting

  • Hospital Británico de Buenos Aires_Site n. 032029

    Buenos Aires, 1275

    Alejandro Salvado

    Recruiting

  • Centro Medico de Enfermedades Respiratorias_Site n. 032002

    Buenos Aires, 1602

    Miguel Angel Bergna

    Recruiting

  • Centro Medico Respire_Site n. 032014

    Buenos Aires, 1646

    Reynaldo Marciano Smith

    Recruiting

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

    Buenos Aires, 1887

    Rocio Fernandez Bazerque

    Recruiting

  • Centro de Investigaciones Médicas Mar del Plata_Site n. 032019

    Buenos Aires, 7600

    Manuel Naveyra

    Recruiting

  • Fundacion CIDEA_Site n. 032009

    Buenos Aires, C1121ABE

    Jorge Maspero

    Recruiting

  • Centro Medico Arsema_Site n. 032003

    Buenos Aires, C1427BCR

    Marcelo Casas

    Recruiting

  • Centro de Investigaciones Metabólicas (CINME)_Site n. 032025

    Ciudad Autonoma de Buenos Aire, 1056ABJ

    Gonzalo Saenz

    Recruiting

  • Centro de Medicina Respiratoria - Concepcion del Uruguay_Site n. 032015

    Ciudad Autonoma de Buenos Aire, 1056ABJ

    Carlos Victorio

    Recruiting

  • CARE - Centro de Alergia y Enfermedades Respiratorias_Site n. 032028

    Ciudad Autonoma de Buenos Aire, 1414

    Andrea Di Cianni

    Recruiting

  • Consultorio Medico Dra. Rivera_Site n. 032012

    Ciudad Autonoma de Buenos Aire, 1426

    Mariana Rivera

    Recruiting

  • Fundación Respirar Salud_Site n. 032004

    Ciudad Autonoma de Buenos Aire, 1426

    Maria Cristina De Salvo

    Recruiting

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

    Córdoba, X5003DCE

    Alexis Cazaux

    Recruiting

  • CePIR_Site n. 032021

    La Plata, 1900

    Gabriel Garcia

    Recruiting

  • Fundacion Scherbovsky_Site n. 032013

    Mendoza, 5500

    Pablo Saez Scherbovsky

    Recruiting

  • Instituto Medico INSARES SA_Site n. 032005

    Mendoza, 5500

    Pedro Elias

    Recruiting

  • Cimro Consultorios Medicos - Centro de Investigacion_Site n. 032006

    Mendoza, 5600

    Ernesto Raso

    Recruiting

  • Centro Respiratorio Quilmes_Site n. 032007

    Quilmes, 1878

    Marcelo Jose Fernandez

    Recruiting

  • Fundacion Innovaciencia_Site n. 032017

    Rosario, 2000

    German Arce

    Recruiting

  • Instituto de Especialidades de la Salud Rosario_Site n. 032020

    Rosario, 2000

    Dario Ardusso

    Recruiting

  • Instituto Medico de la Fundacion de Estudios Clínicos_Site n. 032001

    Rosario, 2000

    Tomas Alvarez

    Recruiting

  • Fundacion Grupo Colaborativo Rosario_Site n. 032010

    Rosario, 2132

    Fernando Massola Adrian

    Recruiting

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

    San Juan Bautista, 1888

    Andrea Medina

    Recruiting

  • Centro Modelo de Cardiologia SRL_Site n. 032016

    San Miguel de Tucumán, 4000

    Roxana Maricel Willigs Rolon

    Recruiting

  • Clinica Mayo de UMCB SRL_Site n. 032026

    San Miguel de Tucumán, 4000

    María Mercedes Espeche

    Recruiting

  • Investigaciones en Patologias Respiratorias_Site n. 032022

    San Miguel de Tucumán, T4000

    Ana Maria Stok

    Recruiting

  • IBAMEDICA_Site n. 032008

    Santa Fe, 3000

    Martin Edgardo Maillo

    Recruiting

Other trials in Argentina

Bulgaria21 sites, 21 recruiting

  • MHAT Sv. Ivan Rilski - Gorna Oryahovitsa_Site n.100017

    Gorna Oryahovitsa, 5100

    Ivancho Draganchev

    Recruiting

  • Medical Center Pulmo - 2018_Site n. 100007

    Haskovo, 6300

    Veselin Kalfov

    Recruiting

  • MC ZDRAVE 1 - Kozloduy_Site n. 100009

    Kozloduy, 3320

    Rumen Stoyanov Tiholov

    Recruiting

  • Medical Centre Pratia Clinic EOOD - Lovech_Site n. 100012

    Lovech, 5500

    Mihail Kirov

    Recruiting

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

    Pernik, 2300

    Galina Petrova

    Recruiting

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

    Pleven, 5804

    Iliya Krachunov

    Recruiting

  • Medical Centre ''Unimed'' EOOD_Site n. 100003

    Plovdiv, 4000

    Maria Dimitrova

    Recruiting

  • MHAT "St. Ivan Rilski "- Razgrad_Site 100013

    Razgrad, 7200

    Oleg Nemechkin

    Recruiting

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

    Razgrad, 7200

    Talyat Cholak

    Recruiting

  • Re Spiro Medical Center_Site n. 100018

    Razgrad, 7200

    Ivan Kiselov

    Recruiting

  • Medical Center Hermes Ruse_Site n. 100011

    Rousse, 7002

    Nikolay Nikolaev

    Recruiting

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

    Rousse, 7002

    Elena Docheva

    Recruiting

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

    Sliven, 8800

    Petyo Petkov

    Recruiting

  • Medical Center Hera EOOD_Site n. 100006

    Sofia, 1000

    Gergana Ilieva-Georgieva

    Recruiting

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

    Sofia, 1142

    Dinko Valev

    Recruiting

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

    Sofia, 1202

    Nadya Koteva

    Recruiting

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

    Sofia, 1407

    Svetlomir Takov

    Recruiting

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

    Stara Zagora, 6000

    Vanya Dimova Ilieva-Fartunova

    Recruiting

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

    Stara Zagora, 6000

    Damyan Arabadzhiev

    Recruiting

  • Medical Centre New Rehabilitation Centre EOOD_Site n. 100010

    Stara Zagora, 6001

    Gyongyver Szaloky

    Recruiting

  • Medical Centre Pratia Clinic EOOD - Varna_Site 100001

    Varna, 9020

    Iskra Velichkova

    Recruiting

Other trials in Bulgaria

Germany19 sites, 19 recruiting

  • Velocity Clinical Research Germany, Ahrensburg_Site n. 276020

    Ahrensburg, 22926

    Sameer Kulkarni

    Recruiting

  • Studienpraxis Berlin-Brandenburg_Site n. 276005

    Berlin, 10119

    Lennart Schaper

    Recruiting

  • Praxis an der Oper_Site n. 276016

    Berlin, 10625

    Thomas Lienert

    Recruiting

  • Lungenpraxis Hohenzollerndamm_Site n. 276004

    Berlin, 10717

    Anneliese Linnhoff

    Recruiting

  • Velocity Clinical Research Germany GmbH_Site 276010

    Berlin, 10787

    Isabelle Schenkenberger

    Recruiting

  • Polikum Institut GmbH_Site n. 276006

    Berlin, 12157

    Michael Sebert

    Recruiting

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

    Berlin, 12159

    Matthias Kruell

    Recruiting

  • MECS research GmbH_Site 276011

    Berlin, 12203

    Thomas Schultz

    Recruiting

  • MECS Cottbus GmbH_Site n. 276007

    Cottbus, 03050

    Iwona Cwiek

    Recruiting

  • Klifeck GmbH_Site n. 276002

    Delitzsch, 04509

    Gerald Eckhardt

    Recruiting

  • Schwerpunktpraxis Lungen- und Bronchialheilkunde Allergologie und Schlafmedizin_Site n. 276009

    Düsseldorf, 40217

    Ulrike Neise

    Recruiting

  • Velocity Clinical Research Germany GmbH_Site n. 276019

    Hamburg, 20095

    Anastasia Kelidou

    Recruiting

  • Gemeinschaftspraxis für Pneumologie, Allergologie und Schlafmedizin_Site n. 276012

    Ibbenbueren, 49477

    Christoph Stolpe

    Recruiting

  • Pulmologische Praxis Dr. Brunner_Site n. 276013

    Leipzig, 04157

    Falk Brunner

    Recruiting

  • Velocity Clinical Research Leipzig GmbH_Site n. 276018

    Leipzig, 04177

    Thomas Muller

    Recruiting

  • Practice for pneumology and allergology_Site n. 276021

    Leipzig, 04299

    Gerhard Hoheisel

    Recruiting

  • POIS Sachsen_Site n. 276001

    Leipzig, 04347

    Juliana Brode

    Recruiting

  • Zentrum Fur Ambulante Pneumologische Forschung Mbg GbR_Site n. 276015

    Marburg, 35037

    Lukas Jerrentrup

    Recruiting

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

    Neu-Isenburg, 63263

    Sabine Ballenberger

    Recruiting

Other trials in Germany

Ukraine15 sites, 15 recruiting

  • Chernivtsi Regional Clinical Hospital_Site n. 804006

    Chernivtsi, 58000

    Svitlana Kovalenko

    Recruiting

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

    Dnipro, 49006

    Evgeniya Dytyatkovska

    Recruiting

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

    Ivano-Frankivsk, 76012

    Sergiy Fedorov

    Recruiting

  • The Ivano-Frankivsk National Medical Univeristy_Site n. 804004

    Ivano-Frankivsk, 76018

    Vira Myhovych

    Recruiting

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

    Ivano-Frankivsk, 76019

    Mykola Ostrovskyy

    Recruiting

  • Medical Center "ARTES MEDICUM" LLC_Site n. 804002

    Kyiv, 02002

    Dmytro Dobrianskyi

    Recruiting

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

    Kyiv, 03038

    Nataliia Prymushko

    Recruiting

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

    Kyiv, 04114

    Ervin Asanov

    Recruiting

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

    Kyiv, 3049

    Bogdan Gundertaylo

    Recruiting

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

    Kyiv, 3680

    Volodymyr Gavrysyuk

    Recruiting

  • Odesa Regional Clinical Hospital of Odesa Regional Council_Site n. 804008

    Odesa, 65025

    Yuliia Novosolova

    Recruiting

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

    Poltava, 36039

    Ivan Kryvoruchko

    Recruiting

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

    Vinnytsia, 21029

    Sergii Shevchuk

    Recruiting

  • Vinnytsia City Clinical Hospital No. 1_Site n. 804005

    Vinnytsia, 21029

    Tetyana Konstantynovych

    Recruiting

  • Vinnytsia City Clinical Hospital No. 1_Site n. 804012

    Vinnytsia, 21029

    Nataliya Slepchenko

    Recruiting

Other trials in Ukraine

Romania13 sites, 13 recruiting

  • Spitalul de Pneumoftiziologie Bacau_Site n. 642014

    Bacau, 600252

    Dragos Gabriel Ungureanu

    Recruiting

  • ANGISAN GRUP SRL_Site n. 642005

    Bragadiru, 077025

    Angelica Savu

    Recruiting

  • Pneumo Bronho Med_Site n. 642002

    Brasov, 500051

    Ionela Iovan

    Recruiting

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

    Brasov, 500051

    Ioana Agache

    Recruiting

  • Spitalul Clinic Colentina_Site n. 642010

    Bucharest, 020125

    Poliana Leru

    Recruiting

  • Spitalul Clinic Nr.1 Cai Ferate Witing_Site n. 642008

    Bucharest, 10243

    Ana Maria Trailescu

    Recruiting

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

    Bucharest, 14461

    Veronica Surlea

    Recruiting

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

    Craiova, 200515

    Dragos Nicolosu

    Recruiting

  • SC Medical Center SRL_Site n. 642013

    Deva, 330084

    Ioan Petrui

    Recruiting

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

    Oradea, 410290

    Cristian Stefan Mago

    Recruiting

  • SC M-Profilaxis SRL_Site n. 642004

    Timișoara, 300041

    Carmen Panaitescu

    Recruiting

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

    Timișoara, 300298

    Stefan Mihaicuta

    Recruiting

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

    Timișoara, 300310

    Cristian Oancea

    Recruiting

Other trials in Romania

South Africa13 sites, 13 recruiting

  • Tiervlei Trial Centre_Site n. 710007

    Bellville, 7530

    Karla Morrison

    Recruiting

  • Worthwhile Clinical Trials_Site n. 710003

    Benoni, 1501

    Nazreen Jeewa Hussen

    Recruiting

  • IATROS International_Site n. 710008

    Bloemfontein, 9301

    Nyda Fourie

    Recruiting

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

    Cape Town, 7530

    Karla Morrison

    Recruiting

  • Precise Clinical Solutions_Site n. 710004

    Chatsworth, 4092

    Visvakuren Naidoo

    Recruiting

  • Synapta Clinical Research Centre_Site n. 710006

    Durban, 4001

    Farzana Hoosen

    Recruiting

  • TASK Eden_Site n. 710001

    George, 6529

    Suzanne Staples

    Recruiting

  • Meditrial_Site n. 710002

    KwaZulu, 3201

    Jessica Fryer

    Recruiting

  • Mzansi Ethical Research Centre (MERC)_Site n. 710005

    Middelburg, 1050

    Mohammed Siddique Tayob

    Recruiting

  • Johese Clinical Research - Centurion_Site 710010

    Pretoria, 157

    Johannes Giessing

    Recruiting

  • Botho Ke Bontle Healthcare Pty LTD_Site n. 710012

    Pretoria, 184

    Salphy Mokgadi Mogashoa

    Recruiting

  • Global Clinical Trials Pty Ltd_Site n. 710011

    Pretoria, 83

    Larisha Pillay-Ramaya

    Recruiting

  • Welkom Clinical Trial Centre_Site n. 710013

    Welkom, 9460

    Yacoob Vahed

    Recruiting

Other trials in South Africa

Hungary11 sites, 11 recruiting

  • Trial Pharma Kft. - TPKFT_Site n. 348011

    Békéscsaba, 5600

    Ibolya Vendrey-Laczo

    Recruiting

  • Edelenyi Koch Robert Korhaz Es Rendelointezet_Site n. 348013

    Edelény, 3780

    Melinda Szabo

    Recruiting

  • Szalay Janos Rendelointezet_Site n. 348006

    Hajdúnánás, 4080

    Aniko Kurucz

    Recruiting

  • BKS Research Kft._Site n. 348001

    Hatvan, H-3000

    Agota Bencze

    Recruiting

  • Bajcsy-Zsilinszky Korhaz es Rendelointezet_Site n. 348002

    Monor, 2200

    Zoltan Bende Bende

    Recruiting

  • Revamed Kft._Site n. 348004

    Nyíregyháza, 4400

    Valeria Csajbok

    Recruiting

  • Simplex Kft._Site n. 348007

    Nyíregyháza, 4481

    Tamas Kardos

    Recruiting

  • Trial Pharma Kft. - Szeged_Site n. 348010

    Szeged, 6726

    Gyongyver Szaloky

    Recruiting

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

    Szolnok, 5000

    Margit Biro

    Recruiting

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz_Site n. 348005

    Szombathely, 9700

    Zsuzsanna Cseke

    Recruiting

  • K&B Sleepmed Kft_Site n. 348008

    Szombathely, H-9700

    Krisztina Hajdu

    Recruiting

Other trials in Hungary

Serbia11 sites, 11 recruiting

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

    Belgrade, 11000

    Vesna Djuric

    Recruiting

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

    Belgrade, 11000

    Ana Samardzic

    Recruiting

  • Municipal Institute for Lung Disease and Tuberculosis_Site n. 688010

    Belgrade, 11120

    Gorana Sovljanski

    Recruiting

  • Klinički Centar Kragujevac_Site n. 688007

    Kragujevac, 34000

    Slavica Mojsilovic

    Recruiting

  • Klinički Centar Kragujevac_Site n. 688003

    Kragujevac, 34111

    Ivan Cekerevac

    Recruiting

  • Clinical Centre of Nis_Site n. 688011

    Niš, 18000

    Ivana Stankovic

    Recruiting

  • Institute for Lung Diseases and Tuberculosis - Nis_Site n. 688001

    Niš, 18101

    Sasa Jovanovic

    Recruiting

  • Institute for Pulmonary Diseases of Vojvodina_Site n. 688006

    Novi Sad, 21000

    Miroslav Ilic

    Recruiting

  • Institute for Pulmonary Diseases of Vojvodina_Site n. 688012

    Sremska Mitrovica, 21208

    Violeta Kolarov

    Recruiting

  • Zdravstveni Centar Užice_Site n. 688008

    Užice, 31000

    Zorica Radojevic

    Recruiting

  • Health Center Valjevo, General Hospital Valjevo_Site n. 688002

    Valjevo, 14000

    Dejan Sofronic

    Recruiting

Other trials in Serbia

United Kingdom10 sites, 10 recruiting

  • Ormeau Clinical Trials Ltd._Site n. 826005

    Belfast, BT2 8BG

    Damien McNally

    Recruiting

  • North Bristol NHS Trust - Southmead Hospital Bristol_Site n. 826010

    Bristol, BS10 5NB

    James Dodd

    Recruiting

  • Concord Medical Centre_Site n. 826009

    Bristol, BS34 6BQ

    James Case

    Recruiting

  • Elpida Trials - Parloes Hub_Site n. 826003

    Dagenham, RM9 5QP

    Ravali Goriparthi

    Recruiting

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

    London, IG1 4HP

    Martin Palin

    Recruiting

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

    Maidstone, ME16 9QQ

    Tuck-Kay Loke

    Recruiting

  • Medicines Evaluation Unit_Site n. 826006

    Manchester, M23 9QZ

    Dave Singh

    Recruiting

  • Accellacare South London_Site n. 826001

    Orpington, BR5 3QG

    Njobuenwnu Hyacienth Amah

    Recruiting

  • Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital_Site n. 826002

    Portsmouth, PO6 3LY

    Thomas Brown

    Recruiting

  • Abbeywell Surgery_Site n. 826007

    Romsey, SO51 8EN

    Nicola Lester

    Recruiting

Other trials in United Kingdom

Bosnia and Herzegovina9 sites, 9 recruiting

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

    Banja Luka, 78000

    Maja Latincic

    Recruiting

  • Sveti apostol Luka Doboj_Site n. 070005

    Doboj, 74000

    Zeljana Panic

    Recruiting

  • Dr. Abdulah Nakas General Hospital_Site n. 070007

    Sarajevo, 71000

    Tijana Muhic-Skalonja

    Recruiting

  • Dr. Abdulah Nakas General Hospital_Site n. 070009

    Sarajevo, 71000

    Armin Hadzic

    Recruiting

  • Organizational unit Novi Grad_Site n. 070003

    Sarajevo, 71000

    Alisa Krivic

    Recruiting

  • University Clinical Hospital Mostar_Site n. 07001

    Siroki Brijeg, 88226

    Kristina Galic

    Recruiting

  • Opca Bolnica Tesanj_Site n. 070006

    Tešanj, 74260

    Besim Prnjavorac

    Recruiting

  • Dr. Mustafa Sehovic Public Medical Center_Site n. 070008

    Tuzla, 75000

    Edin Jusufovic

    Recruiting

  • University Clinical Centre Tuzla_Site n. 070002

    Tuzla, 75000

    Dzenan Halilovic

    Recruiting

Other trials in Bosnia and Herzegovina

Czechia7 sites, 7 recruiting

  • MEDITRIAL, s.r.o._Site n. 203003

    Jindřichův Hradec, 377 01

    Petr Kopecky

    Recruiting

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

    Louny, 44001

    Michala Cervena Sulcova

    Recruiting

  • Cefispiro s.r.o_Site n. 203006

    Lovosice, 41002

    Petra Filipova

    Recruiting

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

    Měšice, 25064

    Jaromir Musil

    Recruiting

  • MUDr. Ilona Pavlišová sro_Site n. 203007

    Miroslav, 67271

    Ilona Pavlisova

    Recruiting

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

    Teplice, 41501

    Stanislav Holub

    Recruiting

  • PNEUMOLOGIE Varnsdorf_Site n. 203005

    Varnsdorf, 40747

    Milan Sklenar

    Recruiting

Other trials in Czechia

Latvia5 sites, 5 recruiting

  • VCA Polyclinic DUBULTI_Site n. 428006

    Jūrmala, 2015

    Natalija Visocka

    Recruiting

  • Riga 1st Hospital_Site n. 428003

    Riga, 1001

    Ilze Reinholde

    Recruiting

  • Paula Stradiņa Klīniskā Universitātes Slimnīca_Site n. 428001

    Riga, 1002

    Aurika Babjoniseva

    Recruiting

  • Consilium Medicum_Site n. 428002

    Riga, 1010

    Maris Bukovskis

    Recruiting

  • SIA Rigas Austrumu Kliniska Universitates Slimnica - Gailezers_Site n. 428005

    Riga, 1038

    Inga Vikmane

    Recruiting

Other trials in Latvia

Mexico3 sites, 3 recruiting

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

    Durango, 34000

    Ricardo Alberto Ramirez Terrones

    Recruiting

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

    Mérida, 97130

    Matilde Damian-Hernandez

    Recruiting

  • Centro Respiratorio de México_Site n. 484008

    Mexico City, 14050

    Raul Humberto Sansores Martínez

    Recruiting

Other trials in Mexico

Slovakia3 sites, 3 recruiting

  • Alian, s.r.o._Site n. 703001

    Bardejov, 085 01

    Maria Dzupinova

    Recruiting

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

    Levice, 934 01

    Daniela Hasicova

    Recruiting

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

    Spišská Nová Ves, 052 01

    Slavomir Hrebenar

    Recruiting

Other trials in Slovakia

About this study

Official title: 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.

Read the 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.

Conditions
Asthma
Being tested
CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a, CHF718 pMDI with HFA-134a
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHF5993 pMDI with HFA-152aDrug

    two puffs BID (twice daily)

  • CHF5993 pMDI with HFA-134aDrug

    two puffs BID

  • CHF718 pMDI with HFA-134aDrug

    two puffs BID

Study groups in NCT07301736
Study groupRoleWhat they receive
Test Treatment: CHF5993 pMDI (Pressurised Metered Dose Inhaler) with HFA-152aExperimentalBDP (Beclometasone Dipropionate)/FF (Formoterol Fumarate)/GB (Glycopyrronium Bromide) 100/6/12.5 µg
Receives: Drug: CHF5993 pMDI with HFA-152a
Reference Treatment 1: CHF5993 pMDI with HFA-134aActive comparatorBDP/FF/GB 100/6/12.5 µg
Receives: Drug: CHF5993 pMDI with HFA-134a
Reference Treatment 2: CHF718 pMDI with HFA-134aActive comparatorBDP 100 µg
Receives: Drug: CHF718 pMDI with HFA-134a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. Change from baseline in pre-dose FEV1 on Day 28

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start17 Dec 2025
  3. Primary completion3 Jun 2027 (estimated)
  4. Study completion3 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
780 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07301736
Sponsor's protocol ID
CLI-05993AA9-01
Other IDs
2025-521456-35-00, 2025
Acronym
TRECONY
Status last verified
Jun 2026
First submitted
11 Dec 2025
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a and CHF718 pMDI with HFA-134a in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 167 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in Argentina, Bulgaria, Germany, Ukraine, Romania and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chiesi Clinical Trial Info Chiesi Clinical Trials (+39 0521 2791, clinicaltrials_info@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07301736.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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