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
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.
3 other identifiers
interventional
827
14 countries
118
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Nov 2023
118 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
November 13, 2023
CompletedStudy Start
First participant enrolled
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2025
CompletedApril 14, 2026
April 1, 2026
1.2 years
November 13, 2023
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (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
Day 1
Secondary Outcomes (10)
To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1)
Day 1, Day 7, Week 4, Week 12
To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1)
Day 1, Day 7, Week 4, Week 12
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)
Day 1, Day 7, Week 4, Week 12
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)
Day 1, Day 7, Week 4, Week 12
To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1)
Day 1, Day 7, Week 12
- +5 more secondary outcomes
Other Outcomes (4)
To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs).
Through study completion, an average of 1 year
To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest.
Through study completion, an average of 1 year
To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest.
Through study completion, an average of 1 year
- +1 more other outcomes
Study Arms (2)
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-152a
EXPERIMENTALActive ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-152a propellant.
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
ACTIVE COMPARATORActive ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-134a propellant.
Interventions
Pressurised Metered Dose Inhaler-2 inhalations twice daily
Pressurised Metered Dose Inhaler-2 inhalations twice daily
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (118)
"IPSMCPP-D-R Veleva" EOOD
Burgas, Bulgaria
Medical Center "Zdrave -1"
Kozloduy, Bulgaria
"AIPSMP Yuskyan Aliosman" Ltd
Momchilgrad, Bulgaria
Ambulatory for Specialized Outpatient Medical Care - Individual Practice
Rousse, 7000, Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov - Ruse Ltd.
Rousse, 7002, Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov
Rousse, 7002, Bulgaria
Multiprofile Hospital For Active Treatment - Shumen AD,
Shumen, 9700, Bulgaria
Diagnostic Consultative Centre 1-
Sliven, 8801, Bulgaria
MHAT Sliven to MMA Sofia
Sliven, Bulgaria
University First Multiprofile Hospital for Active Treatment -Sofia "St. Joan Krastilel" EAD
Sofia, 1142, Bulgaria
Multiprofile Hospital For Active Treatment "Knyaginya Klementina" Sofia EAD,
Sofia, 1233, Bulgaria
Medical Center Hera EOOD, 20 Klisura str., fl. 2,
Sofia, 1510, Bulgaria
Multi-profile Hospital for Active Treatment Zdraveto 2012 Ltd.,
Sofia, 1618, Bulgaria
Diagnostics and Consultation Center Convex EOOD
Sofia, 1680, Bulgaria
"Medical Center Sun i Zdrave"
Sofia, Bulgaria
Medical Center "Syrtuin" Ltd
Sofia, Bulgaria
Medical Center "New Rehabilitation Center" Ltd
Stara Zagora, 6003, Bulgaria
ASMP MC Kissiovi Ltd.
Varna, 9000, Bulgaria
Hornmed, s.r.o
Brno, 618 00, Czechia
Nemocnice Jihlava, Plicní oddělení
Jihlava, 586 01, Czechia
MediTrial s.r.o.
Jindřichův Hradec, 37701, Czechia
Pneumology dpt., Poliklinika Budějovická, MEDICON a.s.
Prague, 140 00, Czechia
Pneumology dpt., Fakultní Thomayerova nemocnice
Prague, 14000, Czechia
Prvni plicni ambulance s.r.o
Prague, 190 00, Czechia
Plicní středisko Teplice s.r.o.
Teplice, 415 01, Czechia
Geo Hospitals Gardabani Multiprofile Medical Centre
Gardabani, Georgia
Geo Hospitals Gurjaani Multiprofile Medical Centre
Gurjaani, Georgia
Geo Hospitals Sagarejo Multiprofile Medical Centre
Sagarejo, Georgia
Medihelp Ltd
Samtredia, Georgia
Imermedi-Imereti Regional Medical Center. (Terjolamedi) Ltd.
T'erjola, 2400, Georgia
Curatio, Jsc
Tbilisi, 0114, Georgia
Geo Hospitals Tbilisi Multiprofile Medical Center
Tbilisi, 0144, Georgia
First Medical Center LLC
Tbilisi, 0180, Georgia
GEO HOSPITALS Zestaphoni Ambulatory Centre
Zestaponi, Georgia
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
Berlin, 10119, Germany
Lungenpraxis Hohenzollerndamm
Berlin, 10717, Germany
Klinische Forschung Berlin
Berlin, 10787, Germany
Policum Berlin Studien GmbH Friedenau
Berlin, 12157, Germany
Institut für Allergie- und Asthmaforschung
Berlin, 12159, Germany
Dr. med. Thomas Ginko Facharzt für Lungen- und Bronchialheilkunde
Bonn, 53119, Germany
Neudorfer Lungenpraxis
Duisburg, 47057, Germany
IKF Pneumologie Frankfurt Clinical Research Centre Respiratory Medicine IFS - Interdisziplinäres Facharztzentrum
Frankfurt, 60596, Germany
Athanasios Xanthopoulos Praxis für Pneumologie
Fürstenwalde, 15517, Germany
Praxis für Pneumologie und Allergologie
Leipzig, 04299, Germany
POIS Sachsen GmbH
Leipzig, 04347, Germany
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, 23552, Germany
SMO Zentrum für klinische Studien
Magdeburg, 39120, Germany
Pneumologisches Studienzentrum München
München, 12159, Germany
Siteworks Prüfzentrum Schleswig GmbH
Schleswig, 24837, Germany
Lungenpraxis Witten
Witten, 58452, Germany
"George Papanikolaou" General Hospital of Thessaloniki
Thessaloniki, 570 10, Greece
University of Debrecen, Infectology Clinic Pulmonary unit
Debrecen, Hungary
Erzsébet Gondozóház
Gödöllő, H-2100, Hungary
BKS Research Kft.,
Hatvan, H-3000, Hungary
Revamed Kft
Nyíregyháza, H-4400, Hungary
INFER-MED Kft
Pécs, Hungary
Árkádia Egészségközpont
Szombathely, H-9700, Hungary
Clinica Malattie Respiratorie e allergologia IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
University of Messina, Allergy and Clinical Immunology Unit, Department of Experimental and Clinical Medicine
Messina, 98125, Italy
Azienda Ospedaliera dei colli - Ospedale Monaldi
Naples, 80131, Italy
EB FlevoResearch BV
Almere Stad, 1311 RL, Netherlands
Amphia Hospital
Breda, 4818 CK, Netherlands
Gelre Hospitals Zutphen (Gelre ziekenhuizen Zutphen)
Zutphen, 7207 AE, Netherlands
Prywatny gabinet internistyczno-alergologiczny prof. Zenon Siergiejko
Bialystok, 15-010, Poland
Centrum Medycyny Oddechowej, Mróz Spółka Jawna
Bialystok, 15-044, Poland
Uniwersytet Medyczny w Bialymstoku Wydzial Nauk o Zdrowiu Klinika Alergologii i Chorób Wewnetrznych
Bialystok, 15-276, Poland
Prywatna praktyka lekarska. Gabinet pediatryczno - alergologiczny
Bialystok, 15-430, Poland
Vitamed Galaj I Cichomski Sp. J.
Bydgoszcz, 85-079, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, 31-011, Poland
Private Health Care MEDYK-KRAK Sp. o.o.
Krakow, 31-455, Poland
Diamond Clinic Spółka z ograniczoną odpowiedzialnością
Krakow, 31-559, Poland
Małopolskie Centrum Alergologii sp. z o.o.
Krakow, 31-624, Poland
ATOPIA Niepubliczny Zakład Opieki Zdrowotnej
Krakow, 35-159, Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
Lodz, 90-153, Poland
Makowskie Centrum Medyczne MCM "Hamernia" Maków Podhalański
Maków Podhalański, 34-220, Poland
Ostrowieckie Centrum Medyczne Spółka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, 27-400, Poland
Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
Rzeszów, 35-051, Poland
Clinmedica Research Sp. Z O.O.
Skierniewice, 96-100, Poland
PULMAG Grzegorz Gąsior, Marzena Kociołek spółka cywilna
Sosnowiec, 41-205, Poland
Centrum Medyczne Lucyna i Andrzej DymeK
Strzelce Opolskie, 47-100, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
Tarnów, 33-100, Poland
CLINICAL BEST SOLUTIONS Fiutkowski Sp. z o.o.
Warsaw, 41-100, Poland
Centrum Badań Klinicznych
Wroclaw, 51-162, Poland
Michał Bogacki Dobrostan
Wroclaw, 53-301, Poland
Lekarze Specjaliści - J. Małolepszy I Partnerzy
Wroclaw, 54-239, Poland
Angisan Grup Srl
Bragadiru, 769764, Romania
Centrul Medical Sana (SANA S.R.L.)
Bucharest, 011025, Romania
National Institute of Pneumology Marius Nasta
Bucharest, 050159, Romania
Medsana Bucharest Medical Center Srl
Bucharest, Romania
Spitalul Clinic de Pneumoftiziologie Leon Daniello
Cluj-Napoca, 400332, Romania
Spitalul Clinic de Pneumoftiziologie Leon Daniello
Cluj-Napoca, 400394, Romania
Spitalul clinic de Pneumoftiziologie Palazu Mare Constanta
Constanța, 900002, Romania
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova
Craiova, 200515, Romania
Spital Judetean de Urgenta Bihor
Oradea, Romania
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara
Timișoara, Romania
Clinical Hospital of Infectious Diseases and Pneumophysiology
Timișoara, Romania
Clinic for Pulmonary Diseases, University Clinical center of Serbia
Belgrade, 11000, Serbia
Municipal Institute for lung diseases and tuberculosis
Belgrade, Serbia
Institute for Pulmonary Diseases of Vojvodina.
Kamenica, 21204, Serbia
Clinic for Pulmonology, University Clinical Center Kragujevac.
Kragujevac, 34000, Serbia
Clinic for Pulmonology, University Clinical Center Kragujevac
Kragujevac, Serbia
Clinical Centre of Niš Clinic for Lung Diseases
Niš, 18000, Serbia
Užice General Hospital Miloša Obrenovića 17.
Užice, 31000, Serbia
Poliklinika ČK PLUS Alian s.r.o
Bardejov, 085 01, Slovakia
Pľucna ambulancia MUDr. Miroslava Undesser
Dunajská Streda, 929 01, Slovakia
Nemocnica s poliklinikou Š. Kukuru Michalovce
Michalovce, 071 01, Slovakia
Pľúcna ambulacia - MUDr. Slavomír Hrebenár
Spišská Nová Ves, 05201, Slovakia
IMUNOALERGOLÓGIA JZ, s.r.o.
Žilina, 010 01, Slovakia
KOMA Kardioprax, s.r.o.
Žilina, 010 01, Slovakia
Hospital General Universitario de Castellón
Castellon, 12004, Spain
Giromed Institute Parc Científic i Tecnològic Universitat de Girona
Girona, 17003, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Complejo Hospitalario Universitario de Santiago Hospital Clínico Universitario de Santiago
Santiago de Compostela, 15706, Spain
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ, United Kingdom
Queen Mary University of London
London, EC1M6BQ, United Kingdom
Guy's & St Thomas'NHS Foundation Trust of Royal Brompton Hospital
London, UB9 6JH, United Kingdom
Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital
Manchester, M23 9QZ, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth, PO6 3LY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dave Singh, MD
Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2023
First Posted
February 20, 2024
Study Start
November 27, 2023
Primary Completion
February 18, 2025
Study Completion
February 24, 2025
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share