Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

464

Participants

Timeline

Start Date

November 26, 2023

Primary Completion Date

March 28, 2026

Study Completion Date

February 17, 2027

Conditions
Uncontrolled Asthma
Interventions
DRUG

Experimental: CHF6001 3200 μg

800 μg/actuation - 2 inhalations of CHF6001 800 μg twice daily (BID) total daily dose 3200 μg

DRUG

Placebo Comparator: CHF6001 Placebo

2 inhalations of CHF6001 matching placebo BID

Trial Locations (187)

Unknown

Site 032020 - Instituto Especialidades de la Salud Rosario - Clinica del Torax, Santa Fe

Site 032027- Centro de Medicina Respiratoria, Argentina

Site 032025 - Sala Mignaburu, Berazategui

Site 032004 - CARE - Centro de Alergia y Enfermedades Respiratorias, Buenos Aires

Site 032008 - Mautalen Salud e Investigacion, Buenos Aires

Site 032014 - Instituto de Investigaciones en Alergia y Enfermedades Respiratorias (INAER), Buenos Aires

Site 032021 - Centro De Investigaciones Medicas Mar Del Plata, Buenos Aires

Site 032024 -CEMLO- Consultorio Medico CEMLO LOBOS, Buenos Aires

Site 032029 - Hospital de Alta Complejidad del Bicentenario de Esteban Echeverría, Buenos Aires

Site 032030 - Instituto de Diagnostico e Investigaciones Metabolicas (IDIM), Buenos Aires

Site 032031 - Centro de Investigaciones Metabolicas (CINME) S.A., Buenos Aires

Site 032032 - Hospital Italiano de Buenos Aires (HIBA), Buenos Aires

Site 032003 -Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L, Ciudad de Buenos Aires

Site 032026 - IAAER-Instituto de Asma, Alergia y Enfermedades Respiratorias, Corrientes

Site 032005 - National University of Cordoba - Rusculleda Foundation - Instituto DAMIC, Córdoba

Site 032010 - Centro Platense en Investigaciones Respiratorias - CEPIR, La Plata

Site 032013 - Centro de Investigacion Medico Lanus-CIMEL CHAHIN CHAHIN S.A, Lanús

Site 032006 -Institute Fundacion Enfisema - Instituto Ave Pulmo; Hospital Privado de Comunidad (HPC), Mar del Plata

Site 032002 -Consultorios Medicos Dr Isaac Scherbovsky - Fundacion Scherbovsky, Mendoza

Site 032009 - Centro Medico INSARES, Mendoza

Site 032023 - Respira Salud Clinica Integral, Mendoza

Site 032011 - Centro Privado de Medicina Respiratoria de Parana - CPMR, Paraná

Site 032007 - Instituto Especialidades de la Salud Rosario - Clinica del Torax, Rosario

Site 032016 - Instituto Medico de la Fundacion Estudios Clinicos, Rosario

Site 032019 - Servicio de Investigacion de Patologias Alergicas del Instituto ABC - Rosario, Rosario

Site 032001 - Instituto de Enfermedades Respiratorias e Investigacion Medica- IERIM, San Juan Bautista

Site 032015 - Fundacion de Estudios Clinicos de Consultorio Integrados Rosario, San Miguel de Tucumán

Site 032018 - Instituto de Investigaciones en Patologias Respiratorias, San Miguel de Tucumán

Site 032022 - Clinica Mayo de Urgencias Medicas Cruz Blanca SRL, San Miguel de Tucumán

Site 032012 - Instituto Del Buen Aire, Santa Fe

Site 032028 - Instituto De Investigaciones Clnicas De Rosario, Santa Fe

Site 032017 - Centro Medico de Enfermedades Respiratorias (CEMER), Vicente López

Site 100012 - Medical Center Asklepii OOD, Dupnitsa

Site 100005 _MHAT Dr. Tota Venkova AD, Gabrovo

Site 100011 - Medical Center Pulmo-2018 EOOD, Haskovo

Site 100022 - MHAT Dr. Atanas Dafovski AD, Kardzhali

Site 100021 - MC Zdrave 1, Kozloduy

"Site 100003 - DCC 1 - Pernik EOOD", Pernik

Site 100010 - Medical Center FAMA, Plovdiv

Site 100017 - MHAT Sveti Panteleymon EOOD, Plovdiv

Site 100025 - Dr. Filip Shterev - Individual ambulatory practice for specialized medical care, Plovdiv

Site 100024 - Medical center Respiro, Razgrad

Site 100006 _ Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd, Rousse

Site 100014 -SBALPFZ - Ruse EOOD, Rousse

Site 100029 - DCC 1 Sevlievo, Sevlievo

Site 100016 - MHAT Shumen AD, Shumen

Site 100004 - MHAT Dr. Ivan Seliminski AD, Sliven

Site 100028 - Smolyan Clinical Research Center, Smolyan

Site 100001- 5th MHAT - Sofia EAD, Sofia

Site 100002 _MHAT St. Ekaterina Dimitrovgrad, Sofia

Site 100008 _Diagnostic Consultative Center Convex Ltd, Sofia

Site 100013 - MHAT Lyulin EAD, Sofia

Site 100015 - Hospital for Pneumatic Physiatric Diseases - Sofia, Sofia

Site 100018 - Medical Center Excelsior Ltd, Sofia

Site 100019 - Aleksandrovska University Hospital, Sofia

Site 100020 -Medical Centre N. I. Pirogov EOOD, Sofia

Site 100023 - University First Multiprofile Hospital for Active treatment-Sofia EAD, Sofia

Site 100030 - Medical Center Hera EOOD, Sofia

Site 100009 - Medical Center Kissiovi, Varna

Site 100027 - Medical Center Research Expert, Varna

Site 100007 _SHATPPD Vratsa, Vratsa

Site 203001 -MUDr. I. Cierna Peterova s.r.o., Brandýs nad Labem

Site 203008 - Fakultni nemocnice Brno, Brno

Site 203002 - MediTrial s.r.o., Jindřichův Hradec

Site 203009 - Alergologie Nemcova s.r.o, Lískovec

203004 -Nemocnice Mesice, Měšice

Site 203006 - Nemocnice Znojmo, Ostrava

Site 203010 - DAWON Spol. s r.o. - Pneumologicka Ambulance, Prague

Site 203011 -Ordinace chorob plicnich s.r.o., Prague

Site 203003 - Plicni Stredisko Teplice, s.r.o., Teplice

Site 203005 - Ambulance Pneumologie a Ftizeologie, Varnsdorf

Site 268001 - Chapidze Emergency Cardiology Center, Tbilisi

Site 268002 - JSC German Hospital, Tbilisi

Site 268003 - French Joint Hepatology Clinic Hepa, Tbilisi

Site 268004 - LTD Helsicore, Tbilisi

Site 268005 - LLC Medi Club Georgia, Tbilisi

Site 268006 - The Firsts University Clinic of Tbilisi State Medical University, Tbilisi

Site 268007 - TSMU & Ingorokva High Medical Technologies University Clinic, Tbilisi

Site 276004 - RCMS, Berlin

Site 276012 - Institut fuer Allergie- und Asthmaforschung Berlin, Berlin

Site 276013 - MECS Research, Berlin

Site 276010 - Office of Dr. Thomas Ginko, MD, Bonn

Site 276014 - MECS Cottbus GmbH, Cottbus

Site 276019 - Praxis Dr. Eckhardt, Delitzsch

Site 276007 - IKF Institut fuer klinische Forschung Frankfurt, Frankfurt am Main

Site 276008 - Office of Dr. med. Claus Keller MD, Frankfurt am Main

Site 276003 - ME Clinical Respiratory Research Hamburg, Hamburg

Site 276015 - Velocity Clinical Research Hamburg GmbH, Hamburg

Site 276002 - Pneumologicum im Suedstadtforum - Hannover, Hanover

Site 276009 - Velocity Clinical Research Leipzig GmbH, Leipzig

Site 276011 - POIS Sachsen GmbH, Leipzig

Site 276020 - BAG Prof. Gerhard Hoheisel/Dr. Andreas Bonitz Praxis für Pneumologie und Allergologie-Studienzentrum, Leipzig

Site 276006 - IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz, Mainz

Site 276001 - Studienzentrum Muenchen-West; Gemeinschaftspraxis fuer Lungen- und Bronchialheilkunde Prof. Dr. med. Rainald Fischer und Dr. med. Michael Baborka, München

Site 276021 - Pneumologische Gemeinschaftspraxis Rheine, Rheine

Site 276022 - Universitaetsmedizin Rostock, Rostock

Site 276016 - Praxisgemeinschaft in Saalfeld - HNO, Saalfeld

Site 276018 - Siteworks Prufzentrum Schleswig-RespiRatio, Schleswig

Site 276005 - Lungenzentrum Ruhr - Praxis fuer Lungenheilkunde, Witten

Site 348006 - Bajcsy-Zsilinszky Hospital, Budapest

Site 348003 - ClinTrial-Kenezy Hospital Institute of Clinical Pharmacology Infectology and Allergology, Debrecen

Site 348001 - Koch Robert Korhaz es Rendelointezet, Edelény

Site 348005 - Szalay Janos Rendelointezet, Hajdúnánás

Site 348004 - INFER-MED Kft. Da Vinci Maganklinika, Pécs

Site 380002 - AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna, Bologna

Site 380003 - Azienda Ospedaliero Universitaria OO RR di Foggia, Foggia

Site 380001 - SC Pneumologia -Fondazione IRCCS Policlinico San Matteo, Pavia

Site 380006 - Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara, Pisa

Site 380005 - Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola, Roma

Site 380004 - Fondazione Salvatore Maugeri I.R.C.C.S. - Istituto Scientifico di Tradate, Tradate

Site 428005 - Balvi and Gulbene hospital union, Balvi

Site 428008 - Dubultu Poliklinika, Jūrmala

Site 428001 - Pauls Stradins Clinical University Hospital, Riga

Site 428002 - Consilium Medicum SIA, Riga

Site 428003 - Latvian University Medical Postgraduate Institute, Riga

Site 428006 - RiGa 1st Hospital, Riga

Site 428007 - SIA RAKUS, Riga

Site 440002 - Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas

Site 440003 - LSMU Kauno ligoninė (Kaunas Hospital of the Lithuanian University of Health Sciences), Kaunas

Site 440006 - CD8 Klinika, Kaunas

Site 440001 - Viesoji Istaiga Antakalnio poliklinika, Vilnius

Site 616011 - Centrum Medycyny Oddechowej, Mroz Spolka Jawna, Bialystok

Site 616017 - NZOZ Przychodnia Vitamed, Bydgoszcz

Site 616024- Mital Site, Elblag

Site 616015 - Centrum Medyczne CLW-MED Aneta Cichomska i Joanna Luka-Wendrowska, Grudziądz

Site 616020 - Pro Familia Altera Sp. z o.o., Katowice

Site 616001 - Malopolskie Centrum Alergologii Sp z o.o, Krakow

Site 616018 - Prywatna Praktyka Lekarska Adam Śmiałowski - Intermed Ksawerów, Ksawerów

Site 616007 - ETG Lodz, Lodz

Site 616009 - Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Lodz

Site 616021 -IP Clinic Sp. z o.o., Lodz

Site 616008 - Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna, Lublin

Site 616025 - MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spolka Jawna, Lublin

Site 616022 - Makowskie Centrum Medyczne Hamernia Sp. z o.o., Maków Podhalański

Site 616013 - Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik, Ostrowiec Świętokrzyski

Site 616006 - Centrum Alergologii Teresa Hofman Sp.z.o.o, Poznan

Site 616019 - Alergologia Plus, Poznan

Site 616023 - Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o, Poznan

Site 616014 - Pawlukiewicz Malgorzata Prywatny Gabinet Lekarski, Rzeszów

Site 616004 - Centrum Medyczne Lucyna Andrazej Dymek - Strzelce Opolskie, Strzelce Opolskie

Site 616005 - Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poradnia Chorob Pluc, Słupsk

Site 616003 - Lekarze Specjalisci - J. Malolepszy i Partnerzy, Wroclaw

Site 616012 - Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy, Wroclaw

Site 616016 - Michal Bogacki Dobrostan, Wroclaw

Site 642005 - Angisan grup srl, Bragadiru

Site 642001 - Centrul Medical de Diagnostic si Tratament Neomed, Brasov

Site 642002 - Institute of Pneumology 'Marius Nasta', Bucharest

Site 642004 - Clinical Hospital Of Pneumology Leon Daniello, Cluj-Napoca

Site 642007 - ICRH Prof DR Octavian Fodor, Sectia Medicina Interna si Ambulator Alergologie, Cluj-Napoca

Site 642003 - Spitalul De Boli Infectioase Victor Babes, Craiova, Craiova

Site 642008 - SPITALUL CLINIC DE PNEUMOFTIZIOLOGIE IASI, Sectia Clinica I de Pneumologie, Iași

Site 642006 - Fundatia Cardioprevent, Timișoara

Site 642009 - Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes, Timișoara

Site 710005 - Worthwhile Clinical Trials, Benoni

Site 710013 - Office of Dr. Agatha Cathrine Wilhase, MD, Boksburg

Site 710016 - Tsitsikamma Clinical Research Initiative, Cape Town

Site 710003 - Office of Dr. ZFA Vawda MD, Durban

Site 710004 - Synapta Clinical Research Center, Durban

Site 710012 - CRISMO Research Centre, Germiston

Site 710015 - University Of The Witwatersrand, Johannesburg

Site 710006 - Langeberg Medicross Medical Centre, Kraaifontein

Site 710002 - Lenmed- Ahmed Kathrada Private Hospital, Lenasia

Site 710007 - Ubuntu Clinical Research, Lenasia

Site 710001 - Emmed Research- Jakaranda Hospital, Pretoria

Site 710009 - Global Clinical Trials, Pretoria

Site 710011 - Busamed Paardevlei Hospital, Somerset West

Site 710014 - University Of Stellenbosch, Stellenbosch

Site 710010 - Limpopo Clinical Research Initiative, Thabazimbi

Site 710008 - Welkom Clinical Trial Centre, Welkom

Site 410003 - Hallym University Sacred Heart Hospital, Anyang-si

Site 410012 - Chungbuk National University Hospital (CBNUH), Cheongju-si

Site 410004 - Jeonbuk National University Hospital, Jeonju

Site 410001 - Konkuk University Medical Center, Seoul

Site 410002 - The Catholic University of Korea, Seoul St. Marys Hospital, Seoul

Site 410005 - Korea University Guro Hospital, Seoul

Site 410006 - Asan Medical Center (AMC), Seoul

Site 410007 - Kangbuk Samsung Hospital, Seoul

Site 410008 - Severance Hospital, Yonsei University Health System, Seoul

Site 410009 - Ajou University Hospital, Suwon

Site 724005 - Clinica Mi Tres Torres Barcelona, Barcelona

Site 724008 - Hospital del SAS de Jerez de la Frontera, Jerez de la Frontera

Site 724007 - Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM), Madrid

Site 724002 - Servicio Andaluz de Salud Consejeria de Salud - Hospital Universitario Virgen de la Victoria, Málaga

Site 724004 - Hospital Universitario Marqués de Valdecilla, Santander

Site 724006 - Complejo Hospitalario Universitario De Santiago, Santiago de Compostela

Site 724003 - Hospital La Plana, Vila-real

Site 724001 - Hospital Universitario Miguel Servet, Zaragoza

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT06029595 - Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy | Biotech Hunter | Biotech Hunter