Clinical trial NCT06264674: 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).
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 836
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
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)
timeFrame: Day 1
Secondary outcomes:
measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1)
timeFrame: Day 1, Day 7, Week 4, Week 12
measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1)
timeFrame: Day 1, Day 7, Week 4, Week 12
measure: 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)
timeFrame: Day 1, Day 7, Week 4, Week 12
measure: 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)
timeFrame: Day 1, Day 7, Week 4, Week 12
measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1)
timeFrame: Day 1, Day 7, Week 12
measure: Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period
timeFrame: Inter-visit, over the entire 12 weeks treatment period
measure: Percentage of days without intake of rescue medication.
timeFrame: Inter-visit, over the entire 12 weeks treatment period
measure: Change in the average daily use of rescue medication.
timeFrame: Inter-visit, over the entire 12 weeks treatment period
measure: Change on the average daily asthma symptoms.
timeFrame: Inter-visit, over the entire 12 weeks treatment period
measure: Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score.
timeFrame: At each planned on site study visit, during the entire 12 weeks treatment period.
Other outcomes:
measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs).
timeFrame: Through study completion, an average of 1 year
measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest.
timeFrame: Through study completion, an average of 1 year
measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest.
timeFrame: Through study completion, an average of 1 year
measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest.
timeFrame: Through study completion, an average of 1 year
Locations:
city: Yerevan
country: Armenia
facility: Yerevan State Medical University, Heratsi N 1 University Hospital Complex
city: Yerevan
country: Armenia
facility: CITO Medical Center
city: Yerevan
country: Armenia
facility: Armenia Republican Medical Center
city: Yerevan
country: Armenia
facility: Erebuni Medical Center
city: Yerevan
country: Armenia
facility: Nairi Medical Center
city: Burgas
country: Bulgaria
facility: "IPSMCPP-D-R Veleva" EOOD
city: Kozloduy
country: Bulgaria
facility: Medical Center "Zdrave -1"
city: Momchilgrad
country: Bulgaria
facility: "AIPSMP Yuskyan Aliosman" Ltd
city: Ruse
country: Bulgaria
facility: Ambulatory for Specialized Outpatient Medical Care - Individual Practice
city: Ruse
country: Bulgaria
facility: Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov - Ruse Ltd.
city: Ruse
country: Bulgaria
facility: Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov
city: Shumen
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment - Shumen AD,
city: Sliven
country: Bulgaria
facility: Diagnostic Consultative Centre 1-
city: Sliven
country: Bulgaria
facility: MHAT Sliven to MMA Sofia
city: Sofia
country: Bulgaria
facility: University First Multiprofile Hospital for Active Treatment -Sofia "St. Joan Krastilel" EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment "Knyaginya Klementina" Sofia EAD,
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD, 20 Klisura str., fl. 2,
city: Sofia
country: Bulgaria
facility: Multi-profile Hospital for Active Treatment Zdraveto 2012 Ltd.,
city: Sofia
country: Bulgaria
facility: Diagnostics and Consultation Center Convex EOOD
city: Sofia
country: Bulgaria
facility: "Medical Center Sun i Zdrave"
city: Sofia
country: Bulgaria
facility: Medical Center "Syrtuin" Ltd
city: Stara Zagora
country: Bulgaria
facility: Medical Center "New Rehabilitation Center" Ltd
city: Varna
country: Bulgaria
facility: ASMP MC Kissiovi Ltd.
city: Brno
country: Czechia
facility: Hornmed, s.r.o
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno, Klinika nemocí plicních a tuberkulózy
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava, Plicní oddělení
city: Jindřichův Hradec
country: Czechia
facility: MediTrial s.r.o.
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc, Klinika plicních nemocí a tuberkulózy
city: Praha
country: Czechia
facility: Pneumology dpt., Poliklinika Budějovická, MEDICON a.s.
city: Praha
country: Czechia
facility: Pneumology dpt., Fakultní Thomayerova nemocnice
city: Praha
country: Czechia
facility: Prvni plicni ambulance s.r.o
city: Teplice
country: Czechia
facility: Plicní středisko Teplice s.r.o.
city: Chiatura
country: Georgia
facility: Geo Hospitals Chiatura Ambulatory Centre
city: Gardabani
country: Georgia
facility: Geo Hospitals Gardabani Multiprofile Medical Centre
city: Gurjaani
country: Georgia
facility: Geo Hospitals Gurjaani Multiprofile Medical Centre
city: Sagarejo
country: Georgia
facility: Geo Hospitals Sagarejo Multiprofile Medical Centre
city: Samtredia
country: Georgia
facility: Medihelp Ltd
city: Tbilisi
country: Georgia
facility: Curatio, Jsc
city: Tbilisi
country: Georgia
facility: Geo Hospitals Tbilisi Multiprofile Medical Center
city: Tbilisi
country: Georgia
facility: First Medical Center LLC
city: Terjola
country: Georgia
facility: Imermedi-Imereti Regional Medical Center. (Terjolamedi) Ltd.
city: Zestap'oni
country: Georgia
facility: GEO HOSPITALS Zestaphoni Ambulatory Centre
city: Berlin
country: Germany
facility: Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
city: Berlin
country: Germany
facility: Lungenpraxis Hohenzollerndamm
city: Berlin
country: Germany
facility: Klinische Forschung Berlin
city: Berlin
country: Germany
facility: Policum Berlin Studien GmbH Friedenau
city: Berlin
country: Germany
facility: Institut für Allergie- und Asthmaforschung
city: Bonn
country: Germany
facility: Dr. med. Thomas Ginko Facharzt für Lungen- und Bronchialheilkunde
city: Duisburg
country: Germany
facility: Neudorfer Lungenpraxis
city: Frankfurt
country: Germany
facility: IKF Pneumologie Frankfurt Clinical Research Centre Respiratory Medicine IFS - Interdisziplinäres Facharztzentrum
city: Furstenwalde
country: Germany
facility: Athanasios Xanthopoulos Praxis für Pneumologie
city: Hamburg
country: Germany
facility: Velocity Clinical Research Hamburg GmbH
city: Leipzig
country: Germany
facility: Praxis für Pneumologie und Allergologie
city: Leipzig
country: Germany
facility: POIS Sachsen GmbH
city: Lübeck
country: Germany
facility: KLB Gesundheitsforschung Lübeck GmbH
city: Magdeburg
country: Germany
facility: SMO Zentrum für klinische Studien
city: München
country: Germany
facility: Pneumologisches Studienzentrum München
city: Schleswig
country: Germany
facility: Siteworks Prüfzentrum Schleswig GmbH
city: Witten
country: Germany
facility: Lungenpraxis Witten
city: Athens
country: Greece
facility: Iatriko Athinon - Paleo Faliro Clinic
city: Ioánnina
country: Greece
facility: University General Hospital of Ioannina
city: Thessaloníki
country: Greece
facility: "George Papanikolaou" General Hospital of Thessaloniki
city: Debrecen
country: Hungary
facility: University of Debrecen, Infectology Clinic Pulmonary unit
city: Gödöllő
country: Hungary
facility: Erzsébet Gondozóház
city: Hatvan
country: Hungary
facility: BKS Research Kft.,
city: Nyíregyháza
country: Hungary
facility: Revamed Kft
city: Pécs
country: Hungary
facility: INFER-MED Kft
city: Szombathely
country: Hungary
facility: Árkádia Egészségközpont
city: Battipaglia
country: Italy
facility: Department of Medicine, "Santa Maria della Speranza" Hospital, Battipaglia, Agency of Health ASL
city: Genova
country: Italy
facility: Clinica Malattie Respiratorie e allergologia IRCCS Ospedale Policlinico San Martino
city: Messina
country: Italy
facility: University of Messina, Allergy and Clinical Immunology Unit, Department of Experimental and Clinical Medicine
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei colli - Ospedale Monaldi
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS; Università Cattolica del Sacro Cuore
city: Almere
country: Netherlands
facility: EB FlevoResearch BV
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Groningen
country: Netherlands
facility: Martini Hospital (Martini Ziekenhuis)
city: Zutphen
country: Netherlands
facility: Gelre Hospitals Zutphen (Gelre ziekenhuizen Zutphen)
city: Białystok
country: Poland
facility: Prywatny gabinet internistyczno-alergologiczny prof. Zenon Siergiejko
city: Białystok
country: Poland
facility: Centrum Medycyny Oddechowej, Mróz Spółka Jawna
city: Białystok
country: Poland
facility: Uniwersytet Medyczny w Bialymstoku Wydzial Nauk o Zdrowiu Klinika Alergologii i Chorób Wewnetrznych
city: Białystok
country: Poland
facility: Prywatna praktyka lekarska. Gabinet pediatryczno - alergologiczny
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj I Cichomski Sp. J.
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed
city: Katowice
country: Poland
facility: Silmedic - centrum medyczne - badania kliniczne Katowice
city: Katowice
country: Poland
facility: VITA LONGA Sp. o.o. (VITA LONGA Sp. z o.o.)
city: Kraków
country: Poland
facility: Centrum Nowoczesnych Terapii "Dobry Lekarz"
city: Kraków
country: Poland
facility: Private Health Care MEDYK-KRAK Sp. o.o.
city: Kraków
country: Poland
facility: Diamond Clinic Spółka z ograniczoną odpowiedzialnością
city: Kraków
country: Poland
facility: Małopolskie Centrum Alergologii sp. z o.o.
city: Kraków
country: Poland
facility: NZOZ Centrum Medyczne ProMiMed
city: Kraków
country: Poland
facility: ATOPIA Niepubliczny Zakład Opieki Zdrowotnej
city: Maków Podhalański
country: Poland
facility: Makowskie Centrum Medyczne MCM "Hamernia" Maków Podhalański
city: Ostrowiec Świętokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne Spółka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
city: Rzeszów
country: Poland
facility: Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
city: Skierniewice
country: Poland
facility: Clinmedica Research Sp. Z O.O.
city: Sosnowiec
country: Poland
facility: PULMAG Grzegorz Gąsior, Marzena Kociołek spółka cywilna
city: Strzelce Opolskie
country: Poland
facility: Centrum Medyczne Lucyna i Andrzej DymeK
city: Tarnów
country: Poland
facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
city: Warsaw
country: Poland
facility: CLINICAL BEST SOLUTIONS Fiutkowski Sp. z o.o.
city: Wrocław
country: Poland
facility: Centrum Badań Klinicznych
city: Wrocław
country: Poland
facility: Michał Bogacki Dobrostan
city: Wrocław
country: Poland
facility: Lekarze Specjaliści - J. Małolepszy I Partnerzy
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
city: Bragadiru
country: Romania
facility: Angisan Grup Srl
city: Bucharest
country: Romania
facility: Medsana Bucharest Medical Center Srl
city: Bucuresti
country: Romania
facility: Centrul Medical Sana (SANA S.R.L.)
city: Bucuresti
country: Romania
facility: National Institute of Pneumology Marius Nasta
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Pneumoftiziologie Leon Daniello
city: Cluj-Napoca
country: Romania
facility: Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Pneumoftiziologie Leon Daniello
city: Constanţa
country: Romania
facility: Spitalul clinic de Pneumoftiziologie Palazu Mare Constanta
city: Craiova
country: Romania
facility: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova
city: Oradea
country: Romania
facility: Spital Judetean de Urgenta Bihor
city: Timişoara
country: Romania
facility: Nova Clin Medical Research Center Srl
city: Timişoara
country: Romania
facility: Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara
city: Timişoara
country: Romania
facility: Clinical Hospital of Infectious Diseases and Pneumophysiology
city: Belgrade
country: Serbia
facility: Clinic for Pulmonary Diseases, University Clinical center of Serbia
city: Belgrade
country: Serbia
facility: Municipal Institute for lung diseases and tuberculosis
city: Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina.
city: Kragujevac
country: Serbia
facility: Clinic for Pulmonology, University Clinical Center Kragujevac.
city: Kragujevac
country: Serbia
facility: Clinic for Pulmonology, University Clinical Center Kragujevac
city: Niš
country: Serbia
facility: Clinical Centre of Niš Clinic for Lung Diseases
city: Užice
country: Serbia
facility: Užice General Hospital Miloša Obrenovića 17.
city: Banská Bystrica
country: Slovakia
facility: F. D. Roosevelt University Hospital
city: Bardejov
country: Slovakia
facility: Poliklinika ČK PLUS Alian s.r.o
city: Dunajská Streda
country: Slovakia
facility: Pľucna ambulancia MUDr. Miroslava Undesser
city: Michalovce
country: Slovakia
facility: Nemocnica s poliklinikou Š. Kukuru Michalovce
city: Spišská Nová Ves
country: Slovakia
facility: Pľúcna ambulacia - MUDr. Slavomír Hrebenár
city: Žilina
country: Slovakia
facility: IMUNOALERGOLÓGIA JZ, s.r.o.
city: Žilina
country: Slovakia
facility: KOMA Kardioprax, s.r.o.
city: Cadiz
country: Spain
facility: Centro Médico HLA La Salud
city: Castello de la Plana
country: Spain
facility: Hospital General Universitario de Castellón
city: Girona
country: Spain
facility: Giromed Institute Parc Científic i Tecnològic Universitat de Girona
city: Madrid
country: Spain
facility: Hospital Central de la Cruz Roja San José y Santa Adela
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago Hospital Clínico Universitario de Santiago
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Queen Mary University of London
city: London
country: United Kingdom
facility: Guy's & St Thomas'NHS Foundation Trust of Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust
Study officials:
affiliation: Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital
name: Dave Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: