Phase
Condition
Asthma
Treatment
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
CHF5993 200/6/12.5 μg pMDI HFA-152a
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofcigarette packs per day x the number of years) and stopped smoking > 1 year (6months 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 inhaledcorticosteroids (ICS) + long-acting β-agonist (LABA) + long-acting muscarinicantagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium andhigh-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 usecorrectly the pMDI inhalers and e-Diary, to be able to read/write, to be able toperform the required outcomes measurements (e.g., technically acceptable spirometry,e-Diary completion) and the ability to understand the risks involved.
Exclusion
Exclusion Criteria:
History of near fatal asthma, hospitalisation for asthma in intensive care unitwhich 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 roomadmission or hospitalisation within 4 weeks prior to study entry and/or during therun-in period (to be checked again prior to randomisation);
Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-relateddiagnosis) not requiring daily asthma control medecine
Study Design
Study Description
Connect with a study center
Armenia Republican Medical Center
Yerevan, 0078
ArmeniaSite Not Available
CITO Medical Center
Yerevan, 0070
ArmeniaSite Not Available
Erebuni Medical Center
Yerevan, 0087
ArmeniaSite Not Available
Nairi Medical Center
Yerevan, 0087
ArmeniaSite Not Available
Yerevan State Medical University, Heratsi N 1 University Hospital Complex
Yerevan, 0025
ArmeniaSite Not Available
"IPSMCPP-D-R Veleva" EOOD
Burgas,
BulgariaSite Not Available
Medical Center "Zdrave -1"
Kozloduy,
BulgariaSite Not Available
"AIPSMP Yuskyan Aliosman" Ltd
Momchilgrad,
BulgariaSite Not Available
Ambulatory for Specialized Outpatient Medical Care - Individual Practice
Ruse, 7000
BulgariaSite Not Available
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov
Ruse, 7002
BulgariaSite Not Available
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov - Ruse Ltd.
Ruse, 7002
BulgariaSite Not Available
Multiprofile Hospital For Active Treatment - Shumen AD,
Shumen, 9700
BulgariaSite Not Available
Diagnostic Consultative Centre 1-
Sliven, 8801
BulgariaSite Not Available
MHAT Sliven to MMA Sofia
Sliven,
BulgariaSite Not Available
"Medical Center Sun i Zdrave"
Sofia,
BulgariaSite Not Available
Diagnostics and Consultation Center Convex EOOD
Sofia, 1680
BulgariaSite Not Available
Medical Center "Syrtuin" Ltd
Sofia,
BulgariaSite Not Available
Medical Center Hera EOOD, 20 Klisura str., fl. 2,
Sofia, 1510
BulgariaSite Not Available
Multi-profile Hospital for Active Treatment Zdraveto 2012 Ltd.,
Sofia, 1618
BulgariaSite Not Available
Multiprofile Hospital For Active Treatment "Knyaginya Klementina" Sofia EAD,
Sofia, 1233
BulgariaSite Not Available
University First Multiprofile Hospital for Active Treatment -Sofia "St. Joan Krastilel" EAD
Sofia, 1142
BulgariaSite Not Available
Medical Center "New Rehabilitation Center" Ltd
Stara Zagora, 6003
BulgariaSite Not Available
ASMP MC Kissiovi Ltd.
Varna, 9000
BulgariaSite Not Available
Fakultní nemocnice Brno, Klinika nemocí plicních a tuberkulózy
Brno, 625
CzechiaSite Not Available
Hornmed, s.r.o
Brno, 618 00
CzechiaSite Not Available
Nemocnice Jihlava, Plicní oddělení
Jihlava, 586 01
CzechiaSite Not Available
MediTrial s.r.o.
Jindřichův Hradec, 37701
CzechiaSite Not Available
Fakultní nemocnice Olomouc, Klinika plicních nemocí a tuberkulózy
Olomouc, 779 00
CzechiaSite Not Available
Pneumology dpt., Fakultní Thomayerova nemocnice
Praha, 14000
CzechiaSite Not Available
Pneumology dpt., Poliklinika Budějovická, MEDICON a.s.
Praha, 140 00
CzechiaSite Not Available
Prvni plicni ambulance s.r.o
Praha, 190 00
CzechiaSite Not Available
Plicní středisko Teplice s.r.o.
Teplice, 415 01
CzechiaSite Not Available
Geo Hospitals Chiatura Ambulatory Centre
Chiatura,
GeorgiaSite Not Available
Geo Hospitals Gardabani Multiprofile Medical Centre
Gardabani,
GeorgiaSite Not Available
Geo Hospitals Gurjaani Multiprofile Medical Centre
Gurjaani,
GeorgiaSite Not Available
Geo Hospitals Sagarejo Multiprofile Medical Centre
Sagarejo,
GeorgiaSite Not Available
Medihelp Ltd
Samtredia,
GeorgiaSite Not Available
Curatio, Jsc
Tbilisi, 0114
GeorgiaSite Not Available
First Medical Center LLC
Tbilisi, 0180
GeorgiaSite Not Available
Geo Hospitals Tbilisi Multiprofile Medical Center
Tbilisi, 0144
GeorgiaSite Not Available
Imermedi-Imereti Regional Medical Center. (Terjolamedi) Ltd.
Terjola, 2400
GeorgiaSite Not Available
GEO HOSPITALS Zestaphoni Ambulatory Centre
Zestap'oni,
GeorgiaSite Not Available
Institut für Allergie- und Asthmaforschung
Berlin, 12159
GermanySite Not Available
Klinische Forschung Berlin
Berlin, 10787
GermanySite Not Available
Lungenpraxis Hohenzollerndamm
Berlin, 10717
GermanySite Not Available
Policum Berlin Studien GmbH Friedenau
Berlin, 12157
GermanySite Not Available
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
Berlin, 10119
GermanySite Not Available
Dr. med. Thomas Ginko Facharzt für Lungen- und Bronchialheilkunde
Bonn, 53119
GermanySite Not Available
Neudorfer Lungenpraxis
Duisburg, 47057
GermanySite Not Available
IKF Pneumologie Frankfurt Clinical Research Centre Respiratory Medicine IFS - Interdisziplinäres Facharztzentrum
Frankfurt, 60596
GermanySite Not Available
Athanasios Xanthopoulos Praxis für Pneumologie
Furstenwalde, 15517
GermanySite Not Available
Velocity Clinical Research Hamburg GmbH
Hamburg, 22143
GermanySite Not Available
POIS Sachsen GmbH
Leipzig, 04347
GermanySite Not Available
Praxis für Pneumologie und Allergologie
Leipzig, 04299
GermanySite Not Available
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, 23552
GermanySite Not Available
SMO Zentrum für klinische Studien
Magdeburg, 39120
GermanySite Not Available
Pneumologisches Studienzentrum München
München, 12159
GermanySite Not Available
Siteworks Prüfzentrum Schleswig GmbH
Schleswig, 24837
GermanySite Not Available
Lungenpraxis Witten
Witten, 58452
GermanySite Not Available
Iatriko Athinon - Paleo Faliro Clinic
Athens, 17562
GreeceSite Not Available
University General Hospital of Ioannina
Ioánnina, 455 00
GreeceSite Not Available
"George Papanikolaou" General Hospital of Thessaloniki
Thessaloníki, 570 10
GreeceSite Not Available
University of Debrecen, Infectology Clinic Pulmonary unit
Debrecen,
HungarySite Not Available
Erzsébet Gondozóház
Gödöllő, H-2100
HungarySite Not Available
BKS Research Kft.,
Hatvan, H-3000
HungarySite Not Available
Revamed Kft
Nyíregyháza, H-4400
HungarySite Not Available
INFER-MED Kft
Pécs,
HungarySite Not Available
Árkádia Egészségközpont
Szombathely, H-9700
HungarySite Not Available
Department of Medicine, "Santa Maria della Speranza" Hospital, Battipaglia, Agency of Health ASL
Battipaglia, 184091
ItalySite Not Available
Clinica Malattie Respiratorie e allergologia IRCCS Ospedale Policlinico San Martino
Genova, 16132
ItalySite Not Available
University of Messina, Allergy and Clinical Immunology Unit, Department of Experimental and Clinical Medicine
Messina, 98125
ItalySite Not Available
Azienda Ospedaliera dei colli - Ospedale Monaldi
Napoli, 80131
ItalySite Not Available
Fondazione Policlinico Universitario A. Gemelli IRCCS; Università Cattolica del Sacro Cuore
Roma, 8 00168
ItalySite Not Available
EB FlevoResearch BV
Almere, 1311 RL
NetherlandsSite Not Available
Amphia Hospital
Breda, 4818 CK
NetherlandsSite Not Available
Martini Hospital (Martini Ziekenhuis)
Groningen, 9728 NT
NetherlandsSite Not Available
Gelre Hospitals Zutphen (Gelre ziekenhuizen Zutphen)
Zutphen, 7207 AE
NetherlandsSite Not Available
Centrum Medycyny Oddechowej, Mróz Spółka Jawna
Białystok, 15-044
PolandSite Not Available
Prywatna praktyka lekarska. Gabinet pediatryczno - alergologiczny
Białystok, 15-430
PolandSite Not Available
Prywatny gabinet internistyczno-alergologiczny prof. Zenon Siergiejko
Białystok, 15-010
PolandSite Not Available
Uniwersytet Medyczny w Bialymstoku Wydzial Nauk o Zdrowiu Klinika Alergologii i Chorób Wewnetrznych
Białystok, 15-276
PolandSite Not Available
Vitamed Galaj I Cichomski Sp. J.
Bydgoszcz, 85-079
PolandSite Not Available
Centrum Medyczne Lukamed
Chojnice, 89-600
PolandSite Not Available
Silmedic - centrum medyczne - badania kliniczne Katowice
Katowice, 40-282
PolandSite Not Available
VITA LONGA Sp. o.o. (VITA LONGA Sp. z o.o.)
Katowice, 40-748
PolandSite Not Available
ATOPIA Niepubliczny Zakład Opieki Zdrowotnej
Kraków, 35-159
PolandSite Not Available
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Kraków, 31-011
PolandSite Not Available
Diamond Clinic Spółka z ograniczoną odpowiedzialnością
Kraków, 31-559
PolandSite Not Available
Małopolskie Centrum Alergologii sp. z o.o.
Kraków, 31-624
PolandSite Not Available
NZOZ Centrum Medyczne ProMiMed
Kraków, 31-820
PolandSite Not Available
Private Health Care MEDYK-KRAK Sp. o.o.
Kraków, 31-455
PolandSite Not Available
Makowskie Centrum Medyczne MCM "Hamernia" Maków Podhalański
Maków Podhalański, 34-220
PolandSite Not Available
Ostrowieckie Centrum Medyczne Spółka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, 27-400
PolandSite Not Available
Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
Rzeszów, 35-051
PolandSite Not Available
Clinmedica Research Sp. Z O.O.
Skierniewice, 96-100
PolandSite Not Available
PULMAG Grzegorz Gąsior, Marzena Kociołek spółka cywilna
Sosnowiec, 41-205
PolandSite Not Available
Centrum Medyczne Lucyna i Andrzej DymeK
Strzelce Opolskie, 47-100
PolandSite Not Available
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
Tarnów, 33-100
PolandSite Not Available
CLINICAL BEST SOLUTIONS Fiutkowski Sp. z o.o.
Warsaw, 41-100
PolandSite Not Available
Centrum Badań Klinicznych
Wrocław, 51-162
PolandSite Not Available
Lekarze Specjaliści - J. Małolepszy I Partnerzy
Wrocław, 54-239
PolandSite Not Available
Michał Bogacki Dobrostan
Wrocław, 53-301
PolandSite Not Available
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
Łódź, 90-153
PolandSite Not Available
Angisan Grup Srl
Bragadiru, 769764
RomaniaSite Not Available
Medsana Bucharest Medical Center Srl
Bucharest,
RomaniaSite Not Available
Centrul Medical Sana (SANA S.R.L.)
Bucuresti, 011025
RomaniaSite Not Available
National Institute of Pneumology Marius Nasta
Bucuresti, 050159
RomaniaSite Not Available
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, 400394
RomaniaSite Not Available
Spitalul Clinic de Pneumoftiziologie Leon Daniello
Cluj-Napoca, 400332
RomaniaSite Not Available
Spitalul clinic de Pneumoftiziologie Palazu Mare Constanta
Constanţa, 900002
RomaniaSite Not Available
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova
Craiova, 200515
RomaniaSite Not Available
Spital Judetean de Urgenta Bihor
Oradea,
RomaniaSite Not Available
Clinical Hospital of Infectious Diseases and Pneumophysiology
Timişoara,
RomaniaSite Not Available
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara
Timişoara,
RomaniaSite Not Available
Nova Clin Medical Research Center Srl
Timişoara, 3000696
RomaniaSite Not Available
Clinic for Pulmonary Diseases, University Clinical center of Serbia
Belgrade, 11000
SerbiaSite Not Available
Municipal Institute for lung diseases and tuberculosis
Belgrade,
SerbiaSite Not Available
Institute for Pulmonary Diseases of Vojvodina.
Kamenica, 21204
SerbiaSite Not Available
Clinic for Pulmonology, University Clinical Center Kragujevac
Kragujevac,
SerbiaSite Not Available
Clinic for Pulmonology, University Clinical Center Kragujevac.
Kragujevac, 34000
SerbiaSite Not Available
Clinical Centre of Niš Clinic for Lung Diseases
Niš, 18000
SerbiaSite Not Available
Užice General Hospital Miloša Obrenovića 17.
Užice, 31000
SerbiaSite Not Available
F. D. Roosevelt University Hospital
Banská Bystrica, 975 17
SlovakiaSite Not Available
Poliklinika ČK PLUS Alian s.r.o
Bardejov, 085 01
SlovakiaSite Not Available
Pľucna ambulancia MUDr. Miroslava Undesser
Dunajská Streda, 929 01
SlovakiaSite Not Available
Nemocnica s poliklinikou Š. Kukuru Michalovce
Michalovce, 071 01
SlovakiaSite Not Available
Pľúcna ambulacia - MUDr. Slavomír Hrebenár
Spišská Nová Ves, 05201
SlovakiaSite Not Available
IMUNOALERGOLÓGIA JZ, s.r.o.
Žilina, 010 01
SlovakiaSite Not Available
KOMA Kardioprax, s.r.o.
Žilina, 010 01
SlovakiaSite Not Available
Centro Médico HLA La Salud
Cadiz, 11008
SpainSite Not Available
Hospital General Universitario de Castellón
Castello de la Plana, 12004
SpainSite Not Available
Giromed Institute Parc Científic i Tecnològic Universitat de Girona
Girona, 17003
SpainSite Not Available
Hospital Central de la Cruz Roja San José y Santa Adela
Madrid, 28003
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Regional Universitario de Málaga
Málaga, 29010
SpainSite Not Available
Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
Complejo Hospitalario Universitario de Santiago Hospital Clínico Universitario de Santiago
Santiago De Compostela, 15706
SpainSite Not Available
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
United KingdomSite Not Available
Guy's & St Thomas'NHS Foundation Trust of Royal Brompton Hospital
London, UB9 6JH
United KingdomSite Not Available
Queen Mary University of London
London, EC1M6BQ
United KingdomSite Not Available
Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital
Manchester, M23 9QZ
United KingdomSite Not Available
Portsmouth Hospitals University NHS Trust
Portsmouth, PO6 3LY
United KingdomSite Not Available
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