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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503333-22-00 | Other Identifier | EMA CTIS | |
| 17142179 | Other Identifier | ISRCTN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaler CHF5993 200/6/12.5 μg pMDI HFA-152a | Experimental | 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 | Active Comparator | Active ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-134a propellant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF5993 200/6/12.5 μg pMDI HFA-152a | Drug | Pressurised Metered Dose Inhaler-2 inhalations twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs). | Number and percentage of subjects experiencing AEs, number and percentage of subjects experiencing at least one ADR and number and percentage of subjects experiencing at least one Treatment Emergent Adverse Events (TEAEs) | Through study completion, an average of 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Singh, MD | Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "IPSMCPP-D-R Veleva" EOOD | Burgas | Bulgaria | ||||
| Medical Center "Zdrave -1" |
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Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group
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Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group
| Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a | Drug | Pressurised Metered Dose Inhaler-2 inhalations twice daily |
|
|
Absolute change from pre-dose in FEV1 at all post-dose timepoints |
| 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) | 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% | 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) | Absolute and relative changes from baseline in pre-dose FEV1 at all clinical visits | 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) | Change from pre-dose in FEV1 AUC 0-2h | Day 1, Day 7, Week 12 |
| 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 | Inter-visit, over the entire 12 weeks treatment period |
| 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 | Inter-visit, over the entire 12 weeks treatment period |
| 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) | Inter-visit, over the entire 12 weeks treatment period |
| 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. | Inter-visit, over the entire 12 weeks treatment period |
| 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). | At each planned on site study visit, during the entire 12 weeks treatment period. |
| To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest. | Number of AEs for each of the following event: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma Exacerbations | 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. | Incident rate for each of the following AE of particular interest: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma Exacerbations. | Through study completion, an average of 1 year |
| To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest. | Rate ratio between treatments for each of the following AE of particular interest: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma Exacerbations. | Through study completion, an average of 1 year |
| 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 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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