Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos)
- Conditions
- Asthma
- Interventions
- Drug: CHF5993 200/6/12.5 μg pMDI HFA-152aDrug: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
- Registration Number
- NCT06264674
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
The CLI-05993AB6-03 Study is an interventional study designed to compare potential for bronchoconstriction, safety and tolerability profile using of HFA 152a propellant versus using to HFA 134a.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 836
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaler CHF5993 200/6/12.5 μg pMDI HFA-152a CHF5993 200/6/12.5 μg pMDI HFA-152a Active 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 Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a Active ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-134a propellant.
- Primary Outcome Measures
Name Time Method 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) Day 1 Relative change from pre-dose in FEV1 at the 10 min post-dose timepoint
- Secondary Outcome Measures
Name Time Method Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period Inter-visit, over the entire 12 weeks treatment period Change from baseline at each inter-visit period and over the entire treatment period in morning and evening PEF
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 Relative change from pre-dose in FEV1 at all the post dose timepoints
Percentage of days without intake of rescue medication. Inter-visit, over the entire 12 weeks treatment period Change from baseline at each inter-visit period and over the entire treatment period in the percentage of days without intake of rescue medications
Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score. At each planned on site study visit, during the entire 12 weeks treatment period. 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).
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 Absolute change from pre-dose in FEV1 at all post-dose timepoints
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 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%
Change in the average daily use of rescue medication. Inter-visit, over the entire 12 weeks treatment period 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)
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 Absolute and relative changes from baseline in pre-dose FEV1 at all clinical visits
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 Change from pre-dose in FEV1 AUC 0-2h
Change on the average daily asthma symptoms. Inter-visit, over the entire 12 weeks treatment period 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.
Trial Locations
- Locations (142)
Yerevan State Medical University, Heratsi N 1 University Hospital Complex
🇦🇲Yerevan, Armenia
CITO Medical Center
🇦🇲Yerevan, Armenia
Armenia Republican Medical Center
🇦🇲Yerevan, Armenia
Erebuni Medical Center
🇦🇲Yerevan, Armenia
Nairi Medical Center
🇦🇲Yerevan, Armenia
"IPSMCPP-D-R Veleva" EOOD
🇧🇬Burgas, Bulgaria
Medical Center "Zdrave -1"
🇧🇬Kozloduy, Bulgaria
"AIPSMP Yuskyan Aliosman" Ltd
🇧🇬Momchilgrad, Bulgaria
Multi-profile Hospital for Active Treatment Zdraveto 2012 Ltd.,
🇧🇬Sofia, Bulgaria
Ambulatory for Specialized Outpatient Medical Care - Individual Practice
🇧🇬Ruse, Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov - Ruse Ltd.
🇧🇬Ruse, Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov
🇧🇬Ruse, Bulgaria
Multiprofile Hospital For Active Treatment - Shumen AD,
🇧🇬Shumen, Bulgaria
Diagnostic Consultative Centre 1-
🇧🇬Sliven, Bulgaria
MHAT Sliven to MMA Sofia
🇧🇬Sliven, Bulgaria
University First Multiprofile Hospital for Active Treatment -Sofia "St. Joan Krastilel" EAD
🇧🇬Sofia, Bulgaria
Multiprofile Hospital For Active Treatment "Knyaginya Klementina" Sofia EAD,
🇧🇬Sofia, Bulgaria
Medical Center Hera EOOD, 20 Klisura str., fl. 2,
🇧🇬Sofia, Bulgaria
Diagnostics and Consultation Center Convex EOOD
🇧🇬Sofia, Bulgaria
"Medical Center Sun i Zdrave"
🇧🇬Sofia, Bulgaria
Medical Center "Syrtuin" Ltd
🇧🇬Sofia, Bulgaria
Medical Center "New Rehabilitation Center" Ltd
🇧🇬Stara Zagora, Bulgaria
ASMP MC Kissiovi Ltd.
🇧🇬Varna, Bulgaria
Hornmed, s.r.o
🇨🇿Brno, Czechia
Fakultní nemocnice Brno, Klinika nemocí plicních a tuberkulózy
🇨🇿Brno, Czechia
Nemocnice Jihlava, Plicní oddělení
🇨🇿Jihlava, Czechia
MediTrial s.r.o.
🇨🇿Jindřichův Hradec, Czechia
Fakultní nemocnice Olomouc, Klinika plicních nemocí a tuberkulózy
🇨🇿Olomouc, Czechia
Pneumology dpt., Poliklinika Budějovická, MEDICON a.s.
🇨🇿Praha, Czechia
Pneumology dpt., Fakultní Thomayerova nemocnice
🇨🇿Praha, Czechia
Prvni plicni ambulance s.r.o
🇨🇿Praha, Czechia
Plicní středisko Teplice s.r.o.
🇨🇿Teplice, Czechia
Geo Hospitals Chiatura Ambulatory Centre
🇬🇪Chiatura, Georgia
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
Curatio, Jsc
🇬🇪Tbilisi, Georgia
Geo Hospitals Tbilisi Multiprofile Medical Center
🇬🇪Tbilisi, Georgia
First Medical Center LLC
🇬🇪Tbilisi, Georgia
Imermedi-Imereti Regional Medical Center. (Terjolamedi) Ltd.
🇬🇪Terjola, Georgia
GEO HOSPITALS Zestaphoni Ambulatory Centre
🇬🇪Zestap'oni, Georgia
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
🇩🇪Berlin, Germany
Lungenpraxis Hohenzollerndamm
🇩🇪Berlin, Germany
Klinische Forschung Berlin
🇩🇪Berlin, Germany
Policum Berlin Studien GmbH Friedenau
🇩🇪Berlin, Germany
Institut für Allergie- und Asthmaforschung
🇩🇪Berlin, Germany
Dr. med. Thomas Ginko Facharzt für Lungen- und Bronchialheilkunde
🇩🇪Bonn, Germany
Neudorfer Lungenpraxis
🇩🇪Duisburg, Germany
IKF Pneumologie Frankfurt Clinical Research Centre Respiratory Medicine IFS - Interdisziplinäres Facharztzentrum
🇩🇪Frankfurt, Germany
Athanasios Xanthopoulos Praxis für Pneumologie
🇩🇪Furstenwalde, Germany
Velocity Clinical Research Hamburg GmbH
🇩🇪Hamburg, Germany
Praxis für Pneumologie und Allergologie
🇩🇪Leipzig, Germany
POIS Sachsen GmbH
🇩🇪Leipzig, Germany
KLB Gesundheitsforschung Lübeck GmbH
🇩🇪Lübeck, Germany
SMO Zentrum für klinische Studien
🇩🇪Magdeburg, Germany
Pneumologisches Studienzentrum München
🇩🇪München, Germany
Siteworks Prüfzentrum Schleswig GmbH
🇩🇪Schleswig, Germany
Lungenpraxis Witten
🇩🇪Witten, Germany
Iatriko Athinon - Paleo Faliro Clinic
🇬🇷Athens, Greece
University General Hospital of Ioannina
🇬🇷Ioánnina, Greece
"George Papanikolaou" General Hospital of Thessaloniki
🇬🇷Thessaloníki, Greece
University of Debrecen, Infectology Clinic Pulmonary unit
🇭🇺Debrecen, Hungary
Erzsébet Gondozóház
🇭🇺Gödöllő, Hungary
BKS Research Kft.,
🇭🇺Hatvan, Hungary
Revamed Kft
🇭🇺Nyíregyháza, Hungary
INFER-MED Kft
🇭🇺Pécs, Hungary
Árkádia Egészségközpont
🇭🇺Szombathely, Hungary
Department of Medicine, "Santa Maria della Speranza" Hospital, Battipaglia, Agency of Health ASL
🇮🇹Battipaglia, Italy
Clinica Malattie Respiratorie e allergologia IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
University of Messina, Allergy and Clinical Immunology Unit, Department of Experimental and Clinical Medicine
🇮🇹Messina, Italy
Azienda Ospedaliera dei colli - Ospedale Monaldi
🇮🇹Napoli, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS; Università Cattolica del Sacro Cuore
🇮🇹Roma, Italy
EB FlevoResearch BV
🇳🇱Almere, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Martini Hospital (Martini Ziekenhuis)
🇳🇱Groningen, Netherlands
Gelre Hospitals Zutphen (Gelre ziekenhuizen Zutphen)
🇳🇱Zutphen, Netherlands
Prywatny gabinet internistyczno-alergologiczny prof. Zenon Siergiejko
🇵🇱Białystok, Poland
Centrum Medycyny Oddechowej, Mróz Spółka Jawna
🇵🇱Białystok, Poland
Uniwersytet Medyczny w Bialymstoku Wydzial Nauk o Zdrowiu Klinika Alergologii i Chorób Wewnetrznych
🇵🇱Białystok, Poland
Prywatna praktyka lekarska. Gabinet pediatryczno - alergologiczny
🇵🇱Białystok, Poland
Vitamed Galaj I Cichomski Sp. J.
🇵🇱Bydgoszcz, Poland
VITA LONGA Sp. o.o. (VITA LONGA Sp. z o.o.)
🇵🇱Katowice, Poland
Centrum Medyczne Lukamed
🇵🇱Chojnice, Poland
Silmedic - centrum medyczne - badania kliniczne Katowice
🇵🇱Katowice, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz"
🇵🇱Kraków, Poland
Private Health Care MEDYK-KRAK Sp. o.o.
🇵🇱Kraków, Poland
Diamond Clinic Spółka z ograniczoną odpowiedzialnością
🇵🇱Kraków, Poland
Małopolskie Centrum Alergologii sp. z o.o.
🇵🇱Kraków, Poland
NZOZ Centrum Medyczne ProMiMed
🇵🇱Kraków, Poland
ATOPIA Niepubliczny Zakład Opieki Zdrowotnej
🇵🇱Kraków, Poland
Makowskie Centrum Medyczne MCM "Hamernia" Maków Podhalański
🇵🇱Maków Podhalański, Poland
Ostrowieckie Centrum Medyczne Spółka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
🇵🇱Ostrowiec Świętokrzyski, Poland
Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
🇵🇱Rzeszów, Poland
Clinmedica Research Sp. Z O.O.
🇵🇱Skierniewice, Poland
PULMAG Grzegorz Gąsior, Marzena Kociołek spółka cywilna
🇵🇱Sosnowiec, Poland
Centrum Medyczne Lucyna i Andrzej DymeK
🇵🇱Strzelce Opolskie, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
🇵🇱Tarnów, Poland
CLINICAL BEST SOLUTIONS Fiutkowski Sp. z o.o.
🇵🇱Warsaw, Poland
Centrum Badań Klinicznych
🇵🇱Wrocław, Poland
Michał Bogacki Dobrostan
🇵🇱Wrocław, Poland
Lekarze Specjaliści - J. Małolepszy I Partnerzy
🇵🇱Wrocław, Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
🇵🇱Łódź, Poland
Angisan Grup Srl
🇷🇴Bragadiru, Romania
Medsana Bucharest Medical Center Srl
🇷🇴Bucharest, Romania
Centrul Medical Sana (SANA S.R.L.)
🇷🇴Bucuresti, Romania
National Institute of Pneumology Marius Nasta
🇷🇴Bucuresti, Romania
Spitalul Clinic de Pneumoftiziologie Leon Daniello
🇷🇴Cluj-Napoca, Romania
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
🇷🇴Cluj-Napoca, Romania
Spitalul clinic de Pneumoftiziologie Palazu Mare Constanta
🇷🇴Constanţa, Romania
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova
🇷🇴Craiova, Romania
Spital Judetean de Urgenta Bihor
🇷🇴Oradea, Romania
Nova Clin Medical Research Center Srl
🇷🇴Timişoara, Romania
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara
🇷🇴Timişoara, Romania
Clinical Hospital of Infectious Diseases and Pneumophysiology
🇷🇴Timişoara, Romania
Clinic for Pulmonary Diseases, University Clinical center of Serbia
🇷🇸Belgrade, Serbia
Municipal Institute for lung diseases and tuberculosis
🇷🇸Belgrade, Serbia
Institute for Pulmonary Diseases of Vojvodina.
🇷🇸Kamenica, Serbia
Clinic for Pulmonology, University Clinical Center Kragujevac.
🇷🇸Kragujevac, Serbia
Clinic for Pulmonology, University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Clinical Centre of Niš Clinic for Lung Diseases
🇷🇸Niš, Serbia
Užice General Hospital Miloša Obrenovića 17.
🇷🇸Užice, Serbia
F. D. Roosevelt University Hospital
🇸🇰Banská Bystrica, Slovakia
Poliklinika ČK PLUS Alian s.r.o
🇸🇰Bardejov, Slovakia
Pľucna ambulancia MUDr. Miroslava Undesser
🇸🇰Dunajská Streda, Slovakia
Nemocnica s poliklinikou Š. Kukuru Michalovce
🇸🇰Michalovce, Slovakia
Pľúcna ambulacia - MUDr. Slavomír Hrebenár
🇸🇰Spišská Nová Ves, Slovakia
IMUNOALERGOLÓGIA JZ, s.r.o.
🇸🇰Žilina, Slovakia
KOMA Kardioprax, s.r.o.
🇸🇰Žilina, Slovakia
Centro Médico HLA La Salud
🇪🇸Cadiz, Spain
Hospital General Universitario de Castellón
🇪🇸Castello de la Plana, Spain
Giromed Institute Parc Científic i Tecnològic Universitat de Girona
🇪🇸Girona, Spain
Hospital Central de la Cruz Roja San José y Santa Adela
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Complejo Hospitalario Universitario de Santiago Hospital Clínico Universitario de Santiago
🇪🇸Santiago De Compostela, Spain
Bradford Teaching Hospitals NHS Foundation Trust
🇬🇧Bradford, United Kingdom
Queen Mary University of London
🇬🇧London, United Kingdom
Guy's & St Thomas'NHS Foundation Trust of Royal Brompton Hospital
🇬🇧London, United Kingdom
Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Portsmouth Hospitals University NHS Trust
🇬🇧Portsmouth, United Kingdom