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AzTrials

AsthmaPhase 3TRECOSNCT06264674

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).

A Phase 3 study testing CHF5993 200/6/12.5 μg pMDI HFA-152a and Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 118 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The CLI-05993AB6-03 Study is an interventional study designed to investigate the safety and efficacy of a new low global warming potential propellant (HFA-152a) compared to the currently approved one (HFA-134a) in the medication (CHF5993) in patients with moderate to severe asthma 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 200/6/12.5 μg pMDI HFA-152a and Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
827 participants
Where
118 sitesin 14 countries
Study dates
27 Nov 2023to 24 Feb 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Subject's written informed consent obtained prior to any study related procedure;
  • Male and female adults aged ≥ 18 and ≤ 75;
  • Body mass index (BMI) within the range of 18.0 to 35.0 kg/m2 inclusive;
  • Non-smokers or ex-smokers who smoked < 10 pack-years (pack-years = the number of cigarette packs per day x the number of years) and stopped smoking > 1 year (6 months for e-cigarettes) prior to screening;
  • Diagnosis of asthma: physician-diagnosed asthma for at least
  • 6 months and with diagnosis before the age of 50 years;
  • Stable asthma therapy: a stable treatment with medium/high doses of inhaled corticosteroids (ICS) + long-acting β-agonist (LABA) + long-acting muscarinic antagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium and high-dose ICS defined as BDP non-extrafine > 500-1000 μg and > 1000 μg respectively, or estimated clinical comparable dose).
  • Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read/write, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved.

Who cannot join

  • History of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the Investigator may place the subject at undue risk, emergency room access for asthma in the previous 6 months before enrolment;
  • Asthma exacerbation requiring systemic corticosteroids (SCS) or emergency room admission or hospitalisation within 4 weeks prior to study entry and/or during the run-in period (to be checked again prior to randomisation);
  • Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medecine

Trial locations and contacts

118 sites in 14 countries.

118 sites in 14 countries

Poland22 sites

  • Prywatny gabinet internistyczno-alergologiczny prof. Zenon Siergiejko

    Bialystok, 15-010

  • Centrum Medycyny Oddechowej, Mróz Spółka Jawna

    Bialystok, 15-044

  • Uniwersytet Medyczny w Bialymstoku Wydzial Nauk o Zdrowiu Klinika Alergologii i Chorób Wewnetrznych

    Bialystok, 15-276

  • Prywatna praktyka lekarska. Gabinet pediatryczno - alergologiczny

    Bialystok, 15-430

  • Vitamed Galaj I Cichomski Sp. J.

    Bydgoszcz, 85-079

  • Centrum Nowoczesnych Terapii "Dobry Lekarz"

    Krakow, 31-011

  • Private Health Care MEDYK-KRAK Sp. o.o.

    Krakow, 31-455

  • Diamond Clinic Spółka z ograniczoną odpowiedzialnością

    Krakow, 31-559

  • Małopolskie Centrum Alergologii sp. z o.o.

    Krakow, 31-624

  • ATOPIA Niepubliczny Zakład Opieki Zdrowotnej

    Krakow, 35-159

  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

    Lodz, 90-153

  • Makowskie Centrum Medyczne MCM "Hamernia" Maków Podhalański

    Maków Podhalański, 34-220

  • Ostrowieckie Centrum Medyczne Spółka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik

    Ostrowiec Świętokrzyski, 27-400

  • Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz

    Rzeszów, 35-051

  • Clinmedica Research Sp. Z O.O.

    Skierniewice, 96-100

  • PULMAG Grzegorz Gąsior, Marzena Kociołek spółka cywilna

    Sosnowiec, 41-205

  • Centrum Medyczne Lucyna i Andrzej DymeK

    Strzelce Opolskie, 47-100

  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.

    Tarnów, 33-100

  • CLINICAL BEST SOLUTIONS Fiutkowski Sp. z o.o.

    Warsaw, 41-100

  • Centrum Badań Klinicznych

    Wroclaw, 51-162

  • Michał Bogacki Dobrostan

    Wroclaw, 53-301

  • Lekarze Specjaliści - J. Małolepszy I Partnerzy

    Wroclaw, 54-239

Other trials in Poland

Bulgaria18 sites

  • "IPSMCPP-D-R Veleva" EOOD

    Burgas

  • Medical Center "Zdrave -1"

    Kozloduy

  • "AIPSMP Yuskyan Aliosman" Ltd

    Momchilgrad

  • Ambulatory for Specialized Outpatient Medical Care - Individual Practice

    Rousse, 7000

  • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov - Ruse Ltd.

    Rousse, 7002

  • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov

    Rousse, 7002

  • Multiprofile Hospital For Active Treatment - Shumen AD,

    Shumen, 9700

  • Diagnostic Consultative Centre 1-

    Sliven, 8801

  • MHAT Sliven to MMA Sofia

    Sliven

  • University First Multiprofile Hospital for Active Treatment -Sofia "St. Joan Krastilel" EAD

    Sofia, 1142

  • Multiprofile Hospital For Active Treatment "Knyaginya Klementina" Sofia EAD,

    Sofia, 1233

  • Medical Center Hera EOOD, 20 Klisura str., fl. 2,

    Sofia, 1510

  • Multi-profile Hospital for Active Treatment Zdraveto 2012 Ltd.,

    Sofia, 1618

  • Diagnostics and Consultation Center Convex EOOD

    Sofia, 1680

  • "Medical Center Sun i Zdrave"

    Sofia

  • Medical Center "Syrtuin" Ltd

    Sofia

  • Medical Center "New Rehabilitation Center" Ltd

    Stara Zagora, 6003

  • ASMP MC Kissiovi Ltd.

    Varna, 9000

Other trials in Bulgaria

Germany16 sites

  • Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR

    Berlin, 10119

  • Lungenpraxis Hohenzollerndamm

    Berlin, 10717

  • Klinische Forschung Berlin

    Berlin, 10787

  • Policum Berlin Studien GmbH Friedenau

    Berlin, 12157

  • Institut für Allergie- und Asthmaforschung

    Berlin, 12159

  • Dr. med. Thomas Ginko Facharzt für Lungen- und Bronchialheilkunde

    Bonn, 53119

  • Neudorfer Lungenpraxis

    Duisburg, 47057

  • IKF Pneumologie Frankfurt Clinical Research Centre Respiratory Medicine IFS - Interdisziplinäres Facharztzentrum

    Frankfurt, 60596

  • Athanasios Xanthopoulos Praxis für Pneumologie

    Fürstenwalde, 15517

  • Praxis für Pneumologie und Allergologie

    Leipzig, 04299

  • POIS Sachsen GmbH

    Leipzig, 04347

  • KLB Gesundheitsforschung Lübeck GmbH

    Lübeck, 23552

  • SMO Zentrum für klinische Studien

    Magdeburg, 39120

  • Pneumologisches Studienzentrum München

    München, 12159

  • Siteworks Prüfzentrum Schleswig GmbH

    Schleswig, 24837

  • Lungenpraxis Witten

    Witten, 58452

Other trials in Germany

Romania11 sites

  • Angisan Grup Srl

    Bragadiru, 769764

  • Centrul Medical Sana (SANA S.R.L.)

    Bucharest, 011025

  • National Institute of Pneumology Marius Nasta

    Bucharest, 050159

  • Medsana Bucharest Medical Center Srl

    Bucharest

  • Spitalul Clinic de Pneumoftiziologie Leon Daniello

    Cluj-Napoca, 400332

  • Spitalul Clinic de Pneumoftiziologie Leon Daniello

    Cluj-Napoca, 400394

  • Spitalul clinic de Pneumoftiziologie Palazu Mare Constanta

    Constanța, 900002

  • Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova

    Craiova, 200515

  • Spital Judetean de Urgenta Bihor

    Oradea

  • Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara

    Timișoara

  • Clinical Hospital of Infectious Diseases and Pneumophysiology

    Timișoara

Other trials in Romania

Georgia9 sites

  • Geo Hospitals Gardabani Multiprofile Medical Centre

    Gardabani

  • Geo Hospitals Gurjaani Multiprofile Medical Centre

    Gurjaani

  • Geo Hospitals Sagarejo Multiprofile Medical Centre

    Sagarejo

  • Medihelp Ltd

    Samtredia

  • Imermedi-Imereti Regional Medical Center. (Terjolamedi) Ltd.

    T'erjola, 2400

  • Curatio, Jsc

    Tbilisi, 0114

  • Geo Hospitals Tbilisi Multiprofile Medical Center

    Tbilisi, 0144

  • First Medical Center LLC

    Tbilisi, 0180

  • GEO HOSPITALS Zestaphoni Ambulatory Centre

    Zestaponi

Other trials in Georgia

Czechia7 sites

  • Hornmed, s.r.o

    Brno, 618 00

  • Nemocnice Jihlava, Plicní oddělení

    Jihlava, 586 01

  • MediTrial s.r.o.

    Jindřichův Hradec, 37701

  • Pneumology dpt., Poliklinika Budějovická, MEDICON a.s.

    Prague, 140 00

  • Pneumology dpt., Fakultní Thomayerova nemocnice

    Prague, 14000

  • Prvni plicni ambulance s.r.o

    Prague, 190 00

  • Plicní středisko Teplice s.r.o.

    Teplice, 415 01

Other trials in Czechia

Serbia7 sites

  • Clinic for Pulmonary Diseases, University Clinical center of Serbia

    Belgrade, 11000

  • Municipal Institute for lung diseases and tuberculosis

    Belgrade

  • Institute for Pulmonary Diseases of Vojvodina.

    Kamenica, 21204

  • Clinic for Pulmonology, University Clinical Center Kragujevac.

    Kragujevac, 34000

  • Clinic for Pulmonology, University Clinical Center Kragujevac

    Kragujevac

  • Clinical Centre of Niš Clinic for Lung Diseases

    Niš, 18000

  • Užice General Hospital Miloša Obrenovića 17.

    Užice, 31000

Other trials in Serbia

Hungary6 sites

  • University of Debrecen, Infectology Clinic Pulmonary unit

    Debrecen

  • Erzsébet Gondozóház

    Gödöllő, H-2100

  • BKS Research Kft.,

    Hatvan, H-3000

  • Revamed Kft

    Nyíregyháza, H-4400

  • INFER-MED Kft

    Pécs

  • Árkádia Egészségközpont

    Szombathely, H-9700

Other trials in Hungary

Slovakia6 sites

  • Poliklinika ČK PLUS Alian s.r.o

    Bardejov, 085 01

  • Pľucna ambulancia MUDr. Miroslava Undesser

    Dunajská Streda, 929 01

  • Nemocnica s poliklinikou Š. Kukuru Michalovce

    Michalovce, 071 01

  • Pľúcna ambulacia - MUDr. Slavomír Hrebenár

    Spišská Nová Ves, 05201

  • IMUNOALERGOLÓGIA JZ, s.r.o.

    Žilina, 010 01

  • KOMA Kardioprax, s.r.o.

    Žilina, 010 01

Other trials in Slovakia

United Kingdom5 sites

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, BD9 6RJ

  • Queen Mary University of London

    London, EC1M6BQ

  • Guy's & St Thomas'NHS Foundation Trust of Royal Brompton Hospital

    London, UB9 6JH

  • Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital

    Manchester, M23 9QZ

  • Portsmouth Hospitals University NHS Trust

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Spain4 sites

  • Hospital General Universitario de Castellón

    Castellon, 12004

  • Giromed Institute Parc Científic i Tecnològic Universitat de Girona

    Girona, 17003

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Complejo Hospitalario Universitario de Santiago Hospital Clínico Universitario de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Italy3 sites

  • Clinica Malattie Respiratorie e allergologia IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • University of Messina, Allergy and Clinical Immunology Unit, Department of Experimental and Clinical Medicine

    Messina, 98125

  • Azienda Ospedaliera dei colli - Ospedale Monaldi

    Naples, 80131

Other trials in Italy

Netherlands3 sites

  • EB FlevoResearch BV

    Almere Stad, 1311 RL

  • Amphia Hospital

    Breda, 4818 CK

  • Gelre Hospitals Zutphen (Gelre ziekenhuizen Zutphen)

    Zutphen, 7207 AE

Other trials in Netherlands

Greece1 site

  • "George Papanikolaou" General Hospital of Thessaloniki

    Thessaloniki, 570 10

Other trials in Greece

About this study

Official title: A 12-week Double-blind, Multicentre, Randomised, Active-controlled, 2-arm, Parallel-group Clinical Trial to Evaluate the Safety of CHF5993 pMDI 200/6/12.5 μg HFA-152a, Compared to CHF5993 pMDI 200/6/12.5 μg HFA-134a, in Subjects With Asthma.

The CLI-05993AB6-03 Study is an interventional study designed to investigate the safety and efficacy of a new low global warming potential propellant (HFA-152a) compared to the currently approved one (HFA-134a) in the medication (CHF5993) in patients with moderate to severe asthma

Read the detailed description

Outpatients attending the hospital clinics/study centers will be recruited. Moderate to severe controlled asthma adult subjects will be recruited. A total of 513 subjects will be randomised. The whole study will last approximately 16 weeks for each subject.

Conditions
Asthma
Being tested
CHF5993 200/6/12.5 μg pMDI HFA-152a, Inhaler CHF5993 200/6/12.5 μg pMDI 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 200/6/12.5 μg pMDI HFA-152aDrug

    Also called HFA-152a propellant

    Pressurised Metered Dose Inhaler-2 inhalations twice daily

  • Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134aDrug

    Also called HFA-134a propellant

    Pressurised Metered Dose Inhaler-2 inhalations twice daily

Study groups in NCT06264674
Study groupRoleWhat they receive
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-152aExperimentalActive ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-152a propellant.
Receives: Drug: CHF5993 200/6/12.5 μg pMDI HFA-152a
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134aActive comparatorActive ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-134a propellant.
Receives: Drug: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a

What is being measured

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

  1. Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment)

    Relative change from pre-dose in FEV1 at the 10 min post-dose timepoint

    Measured: Day 1

Secondary outcomes (10)

  1. To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1)

    Relative change from pre-dose in FEV1 at all the post dose timepoints

    Measured: Day 1, Day 7, Week 4, Week 12

  2. To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1)

    Absolute change from pre-dose in FEV1 at all post-dose timepoints

    Measured: Day 1, Day 7, Week 4, Week 12

  3. To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1)

    Calculation of number and percentage of subjects with a relative decrease from pre-dose in FEV1 at each post-dose timpoint and at any post -dose timepoint > 15%

    Measured: Day 1, Day 7, Week 4, Week 12

  4. To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1)

    Absolute and relative changes from baseline in pre-dose FEV1 at all clinical visits

    Measured: Day 1, Day 7, Week 4, Week 12

  5. To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1)

    Change from pre-dose in FEV1 AUC 0-2h

    Measured: Day 1, Day 7, Week 12

  6. Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period

    Change from baseline at each inter-visit period and over the entire treatment period in morning and evening PEF

    Measured: Inter-visit, over the entire 12 weeks treatment period

  7. Percentage of days without intake of rescue medication.

    Change from baseline at each inter-visit period and over the entire treatment period in the percentage of days without intake of rescue medications

    Measured: Inter-visit, over the entire 12 weeks treatment period

  8. Change in the average daily use of rescue medication.

    Change from baseline at each inter-visit period and over the entire treatment period in the average daily use of rescue medication (number of inhalations/day)

    Measured: Inter-visit, over the entire 12 weeks treatment period

  9. Change on the average daily asthma symptoms.

    Change from baseline at each inter-visit period and over the entire treatment period in the average daily symptoms. Patients are asked to complete daily a questionnaire to collect this information and allow their asthma symptoms to be monitored.

    Measured: Inter-visit, over the entire 12 weeks treatment period

  10. Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score.

    ACQ 7 is a one week recall questionnaire including 6 questions to be completed by patients on a 7-points scale (0=no impairment, 6= maximum impairment) and 7th point capturing the FEV1 % predicted value (also scoring on a 7-point scale). Questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

    Measured: At each planned on site study visit, during the entire 12 weeks treatment period.

Timeline

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

  1. First posted20 Feb 2024
  2. Study start27 Nov 2023
  3. Primary completion18 Feb 2025
  4. Study completion24 Feb 2025

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
827 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06264674
Sponsor's protocol ID
CLI-05993AB6-03
Other IDs
2023-503333-22-00, 17142179, 2023
Acronym
TRECOS
Status last verified
Sep 2026
First submitted
13 Nov 2023
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.

Publications

  • Singh D, Mancini L, Melis G, Cortellini M, Rostello C, Mathews KS. Safety and tolerability of the low global warming potential propellant HFA-152a in patients with asthma receiving beclometasone dipropionate/formoterol fumarate/glycopyrronium: The TRECOS study. Respir Med. 2026 May;256:108814. doi: 10.1016/j.rmed.2026.108814. Epub 2026 Apr 6.

    PubMed 41951188

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CHF5993 200/6/12.5 μg pMDI HFA-152a and Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 118 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in Poland, Bulgaria, Germany, Romania, Georgia 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment) (time frame: Day 1). 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 NCT06264674, which also lists 1 linked publication.

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 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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