Study Stopped
Strategic decision by Sponsor; not due to safety reasons
Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
TANGO
A 52-week, Randomised, Double Blind, Multicentre, 2-arm Parallel Group Trial Assessing Efficacy of CHF6001 (Total Daily Dose 3200μg) Dry Powder Inhaler (DPI) add-on to Maintenance Medium or High Dose of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists in Subjects With Uncontrolled Asthma
2 other identifiers
interventional
517
14 countries
187
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2023
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedStudy Start
First participant enrolled
November 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2025
CompletedDecember 18, 2025
March 1, 2025
2 years
August 31, 2023
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Asthma exacerbation over 52 weeks of treatment
Number of Asthma exacerbation over 52 weeks of treatment (Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization)
Over 52 weeks
Secondary Outcomes (11)
Time to first asthma exacerbation;
Up to 52 weeks
Number of asthma exacerbation and asthma worsening over 52 weeks of treatment
Up to 52 weeks
Time to first asthma exacerbation or asthma worsening
Up to 52 weeks
ACQ-7 responders
week 4, week 26 and week 52
Change from baseline in ACQ-7 and ACQ-6
week 4, week 26 and week 52
- +6 more secondary outcomes
Study Arms (2)
CHF6001 - CHF6001 total daily dose 3200 μg;
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
800 μg/actuation - 2 inhalations of CHF6001 800 μg twice daily (BID) total daily dose 3200 μg
Eligibility Criteria
You may qualify if:
- Subject's written informed consent
- Male or female subjects aged ≥18 and ≤75 years
- A documented history of physician-diagnosed asthma for at least 1 year and with diagnosis before the age of 50 years
- Stable asthma therapy: a stable maintenance treatment with medium to high dose of inhaled corticosteroids plus long acting β2 agonists for at least 3 months prior to screening
- A prebronchodilator FEV1 ≤80% of the predicted normal value
- Bronchodilator responsiveness after inhalation of salbutamol or equivalent
- Evidence of poorly controlled or uncontrolled asthma as based on an ACQ-7 score ≥1.5
- History of asthma exacerbations : at least 1 asthma exacerbation leading to hospitalisation or 2 or more asthma exacerbations within the last 12 months
- A cooperative attitude and ability to use inhalers and to comply with study procedures
You may not qualify if:
- e-Diary completion compliance \<75% during run-in
- History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit
- Recent exacerbation or respiratory tract infection within 4 weeks prior to screening visit or during the run-in period
- Subjects using systemic corticosteroids medication in the 4 weeks or slow-release corticosteroids in the 12 weeks prior to randomisation
- Asthma requiring use of biologics
- Respiratory disorders other than asthma: subjects with known respiratory disorders other than asthma
- Subjects with a history of lung volume resection
- Current smokers, ex-smokers with a smoking history of ≥10 pack-years or current use of inhaled or oral cannabis products.
- Subjects with cancer or history of cancer
- Subjects with cardiovascular diseases
- Subjects with any abnormal and clinically significant 12-lead ECG
- Subjects with previous medical history, evidence of an uncontrolled intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis
- Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour
- Patients mentally or legally incapacitated or patients accommodated in an establishment
- Subjects with liver diseases
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (187)
Site 032020 - Instituto Especialidades de la Salud Rosario - Clinica del Torax
Santa Fe, La, Argentina
Site 032027- Centro de Medicina Respiratoria
Argentina, Argentina
Site 032025 - Sala Mignaburu
Berazategui, Argentina
Site 032004 - CARE - Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, Argentina
Site 032008 - Mautalen Salud e Investigacion
Buenos Aires, Argentina
Site 032014 - Instituto de Investigaciones en Alergia y Enfermedades Respiratorias (INAER)
Buenos Aires, Argentina
Site 032021 - Centro De Investigaciones Medicas Mar Del Plata
Buenos Aires, Argentina
Site 032024 -CEMLO- Consultorio Medico CEMLO LOBOS
Buenos Aires, Argentina
Site 032029 - Hospital de Alta Complejidad del Bicentenario de Esteban Echeverría
Buenos Aires, Argentina
Site 032030 - Instituto de Diagnostico e Investigaciones Metabolicas (IDIM)
Buenos Aires, Argentina
Site 032031 - Centro de Investigaciones Metabolicas (CINME) S.A.
Buenos Aires, Argentina
Site 032032 - Hospital Italiano de Buenos Aires (HIBA)
Buenos Aires, Argentina
Site 032003 -Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L
Ciudad de Buenos Aires, Argentina
Site 032026 - IAAER-Instituto de Asma, Alergia y Enfermedades Respiratorias
Corrientes, Argentina
Site 032005 - National University of Cordoba - Rusculleda Foundation - Instituto DAMIC
Córdoba, Argentina
Site 032010 - Centro Platense en Investigaciones Respiratorias - CEPIR
La Plata, Argentina
Site 032013 - Centro de Investigacion Medico Lanus-CIMEL CHAHIN CHAHIN S.A
Lanús, Argentina
Site 032006 -Institute Fundacion Enfisema - Instituto Ave Pulmo; Hospital Privado de Comunidad (HPC)
Mar del Plata, Argentina
Site 032002 -Consultorios Medicos Dr Isaac Scherbovsky - Fundacion Scherbovsky
Mendoza, Argentina
Site 032009 - Centro Medico INSARES
Mendoza, Argentina
Site 032023 - Respira Salud Clinica Integral
Mendoza, Argentina
Site 032011 - Centro Privado de Medicina Respiratoria de Parana - CPMR
Paraná, Argentina
Site 032007 - Instituto Especialidades de la Salud Rosario - Clinica del Torax
Rosario, Argentina
Site 032016 - Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Argentina
Site 032019 - Servicio de Investigacion de Patologias Alergicas del Instituto ABC - Rosario
Rosario, Argentina
Site 032001 - Instituto de Enfermedades Respiratorias e Investigacion Medica- IERIM
San Juan Bautista, Argentina
Site 032015 - Fundacion de Estudios Clinicos de Consultorio Integrados Rosario
San Miguel de Tucumán, Argentina
Site 032018 - Instituto de Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, Argentina
Site 032022 - Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Argentina
Site 032012 - Instituto Del Buen Aire
Santa Fe, Argentina
Site 032028 - Instituto De Investigaciones Clnicas De Rosario
Santa Fe, Argentina
Site 032017 - Centro Medico de Enfermedades Respiratorias (CEMER)
Vicente López, Argentina
Site 100012 - Medical Center Asklepii OOD
Dupnitsa, Bulgaria
Site 100005 _MHAT Dr. Tota Venkova AD
Gabrovo, Bulgaria
Site 100011 - Medical Center Pulmo-2018 EOOD
Haskovo, Bulgaria
Site 100022 - MHAT Dr. Atanas Dafovski AD
Kardzhali, Bulgaria
Site 100021 - MC Zdrave 1
Kozloduy, Bulgaria
Site 100003 - """DCC 1 - Pernik"" EOOD"
Pernik, Bulgaria
Site 100010 - Medical Center FAMA
Plovdiv, Bulgaria
Site 100017 - MHAT Sveti Panteleymon EOOD
Plovdiv, Bulgaria
Site 100025 - Dr. Filip Shterev - Individual ambulatory practice for specialized medical care
Plovdiv, Bulgaria
Site 100024 - Medical center Respiro
Razgrad, Bulgaria
Site 100006 _ Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd
Rousse, Bulgaria
Site 100014 -SBALPFZ - Ruse EOOD
Rousse, Bulgaria
Site 100029 - DCC 1 Sevlievo
Sevlievo, Bulgaria
Site 100016 - MHAT Shumen AD
Shumen, Bulgaria
Site 100004 - MHAT Dr. Ivan Seliminski AD
Sliven, Bulgaria
Site 100028 - Smolyan Clinical Research Center
Smolyan, Bulgaria
Site 100001- 5th MHAT - Sofia EAD
Sofia, Bulgaria
Site 100002 _MHAT St. Ekaterina Dimitrovgrad
Sofia, Bulgaria
Site 100008 _Diagnostic Consultative Center Convex Ltd
Sofia, Bulgaria
Site 100013 - MHAT Lyulin EAD
Sofia, Bulgaria
Site 100015 - Hospital for Pneumatic Physiatric Diseases - Sofia
Sofia, Bulgaria
Site 100018 - Medical Center Excelsior Ltd
Sofia, Bulgaria
Site 100019 - Aleksandrovska University Hospital
Sofia, Bulgaria
Site 100020 -Medical Centre N. I. Pirogov EOOD
Sofia, Bulgaria
Site 100023 - University First Multiprofile Hospital for Active treatment-Sofia EAD
Sofia, Bulgaria
Site 100030 - Medical Center Hera EOOD
Sofia, Bulgaria
Site 100009 - Medical Center Kissiovi
Varna, Bulgaria
Site 100027 - Medical Center Research Expert
Varna, Bulgaria
Site 100007 _SHATPPD Vratsa
Vratsa, Bulgaria
Site 203001 -MUDr. I. Cierna Peterova s.r.o.
Brandýs nad Labem, Czechia
Site 203008 - Fakultni nemocnice Brno
Brno, Czechia
Site 203002 - MediTrial s.r.o.
Jindřichův Hradec, Czechia
Site 203009 - Alergologie Nemcova s.r.o
Lískovec, Czechia
203004 -Nemocnice Mesice
Měšice, Czechia
Site 203006 - Nemocnice Znojmo
Ostrava, Czechia
Site 203010 - DAWON Spol. s r.o. - Pneumologicka Ambulance
Prague, Czechia
Site 203011 -Ordinace chorob plicnich s.r.o.
Prague, Czechia
Site 203003 - Plicni Stredisko Teplice, s.r.o.
Teplice, Czechia
Site 203005 - Ambulance Pneumologie a Ftizeologie
Varnsdorf, Czechia
Site 268001 - Chapidze Emergency Cardiology Center
Tbilisi, Georgia
Site 268002 - JSC German Hospital
Tbilisi, Georgia
Site 268003 - French Joint Hepatology Clinic Hepa
Tbilisi, Georgia
Site 268004 - LTD Helsicore
Tbilisi, Georgia
Site 268005 - LLC Medi Club Georgia
Tbilisi, Georgia
Site 268006 - The Firsts University Clinic of Tbilisi State Medical University
Tbilisi, Georgia
Site 268007 - TSMU & Ingorokva High Medical Technologies University Clinic
Tbilisi, Georgia
Site 276004 - RCMS
Berlin, Germany
Site 276012 - Institut fuer Allergie- und Asthmaforschung Berlin
Berlin, Germany
Site 276013 - MECS Research
Berlin, Germany
Site 276010 - Office of Dr. Thomas Ginko, MD
Bonn, Germany
Site 276014 - MECS Cottbus GmbH
Cottbus, Germany
Site 276019 - Praxis Dr. Eckhardt
Delitzsch, Germany
Site 276007 - IKF Institut fuer klinische Forschung Frankfurt
Frankfurt am Main, Germany
Site 276008 - Office of Dr. med. Claus Keller MD
Frankfurt am Main, Germany
Site 276003 - ME Clinical Respiratory Research Hamburg
Hamburg, Germany
Site 276015 - Velocity Clinical Research Hamburg GmbH
Hamburg, Germany
Site 276002 - Pneumologicum im Suedstadtforum - Hannover
Hanover, Germany
Site 276009 - Velocity Clinical Research Leipzig GmbH
Leipzig, Germany
Site 276011 - POIS Sachsen GmbH
Leipzig, Germany
Site 276020 - BAG Prof. Gerhard Hoheisel/Dr. Andreas Bonitz Praxis für Pneumologie und Allergologie-Studienzentrum
Leipzig, Germany
Site 276006 - IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz
Mainz, Germany
Site 276001 - Studienzentrum Muenchen-West; Gemeinschaftspraxis fuer Lungen- und Bronchialheilkunde Prof. Dr. med. Rainald Fischer und Dr. med. Michael Baborka
München, Germany
Site 276021 - Pneumologische Gemeinschaftspraxis Rheine
Rheine, Germany
Site 276022 - Universitaetsmedizin Rostock
Rostock, Germany
Site 276016 - Praxisgemeinschaft in Saalfeld - HNO
Saalfeld, Germany
Site 276018 - Siteworks Prufzentrum Schleswig-RespiRatio
Schleswig, Germany
Site 276005 - Lungenzentrum Ruhr - Praxis fuer Lungenheilkunde
Witten, Germany
Site 348006 - Bajcsy-Zsilinszky Hospital
Budapest, Hungary
Site 348003 - ClinTrial-Kenezy Hospital Institute of Clinical Pharmacology Infectology and Allergology
Debrecen, Hungary
Site 348001 - Koch Robert Korhaz es Rendelointezet
Edelény, Hungary
Site 348005 - Szalay Janos Rendelointezet
Hajdúnánás, Hungary
Site 348004 - INFER-MED Kft. Da Vinci Maganklinika
Pécs, Hungary
Site 380002 - AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna
Bologna, Italy
Site 380003 - Azienda Ospedaliero Universitaria OO RR di Foggia
Foggia, Italy
Site 380001 - SC Pneumologia -Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Site 380006 - Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara
Pisa, Italy
Site 380005 - Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola
Roma, Italy
Site 380004 - Fondazione Salvatore Maugeri I.R.C.C.S. - Istituto Scientifico di Tradate
Tradate, Italy
Site 428005 - Balvi and Gulbene hospital union
Balvi, Latvia
Site 428008 - Dubultu Poliklinika
Jūrmala, Latvia
Site 428001 - Pauls Stradins Clinical University Hospital
Riga, Latvia
Site 428002 - Consilium Medicum SIA
Riga, Latvia
Site 428003 - Latvian University Medical Postgraduate Institute
Riga, Latvia
Site 428006 - RiGa 1st Hospital
Riga, Latvia
Site 428007 - SIA RAKUS
Riga, Latvia
Site 440002 - Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania
Site 440003 - LSMU Kauno ligoninė (Kaunas Hospital of the Lithuanian University of Health Sciences)
Kaunas, Lithuania
Site 440006 - CD8 Klinika
Kaunas, Lithuania
Site 440001 - Viesoji Istaiga Antakalnio poliklinika
Vilnius, Lithuania
Site 616011 - Centrum Medycyny Oddechowej, Mroz Spolka Jawna
Bialystok, Poland
Site 616017 - NZOZ Przychodnia Vitamed
Bydgoszcz, Poland
Site 616024- Mital Site
Elblag, Poland
Site 616015 - Centrum Medyczne CLW-MED Aneta Cichomska i Joanna Luka-Wendrowska
Grudziądz, Poland
Site 616020 - Pro Familia Altera Sp. z o.o.
Katowice, Poland
Site 616001 - Malopolskie Centrum Alergologii Sp z o.o
Krakow, Poland
Site 616018 - Prywatna Praktyka Lekarska Adam Śmiałowski - Intermed Ksawerów
Ksawerów, Poland
Site 616007 - ETG Lodz
Lodz, Poland
Site 616009 - Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Poland
Site 616021 -IP Clinic Sp. z o.o.
Lodz, Poland
Site 616008 - Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
Lublin, Poland
Site 616025 - MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spolka Jawna
Lublin, Poland
Site 616022 - Makowskie Centrum Medyczne Hamernia Sp. z o.o.
Maków Podhalański, Poland
Site 616013 - Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Poland
Site 616006 - Centrum Alergologii Teresa Hofman Sp.z.o.o
Poznan, Poland
Site 616019 - Alergologia Plus
Poznan, Poland
Site 616023 - Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
Poznan, Poland
Site 616014 - Pawlukiewicz Malgorzata Prywatny Gabinet Lekarski
Rzeszów, Poland
Site 616004 - Centrum Medyczne Lucyna Andrazej Dymek - Strzelce Opolskie
Strzelce Opolskie, Poland
Site 616005 - Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poradnia Chorob Pluc
Słupsk, Poland
Site 616003 - Lekarze Specjalisci - J. Malolepszy i Partnerzy
Wroclaw, Poland
Site 616012 - Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy
Wroclaw, Poland
Site 616016 - Michal Bogacki Dobrostan
Wroclaw, Poland
Site 642005 - Angisan grup srl
Bragadiru, Romania
Site 642001 - Centrul Medical de Diagnostic si Tratament Neomed
Brasov, Romania
Site 642002 - Institute of Pneumology 'Marius Nasta'
Bucharest, Romania
Site 642004 - Clinical Hospital Of Pneumology Leon Daniello
Cluj-Napoca, Romania
Site 642007 - ICRH Prof DR Octavian Fodor, Sectia Medicina Interna si Ambulator Alergologie
Cluj-Napoca, Romania
Site 642003 - Spitalul De Boli Infectioase Victor Babes, Craiova
Craiova, Romania
Site 642008 - SPITALUL CLINIC DE PNEUMOFTIZIOLOGIE IASI, Sectia Clinica I de Pneumologie
Iași, Romania
Site 642006 - Fundatia Cardioprevent
Timișoara, Romania
Site 642009 - Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
Timișoara, Romania
Site 710005 - Worthwhile Clinical Trials
Benoni, South Africa
Site 710013 - Office of Dr. Agatha Cathrine Wilhase, MD
Boksburg, South Africa
Site 710016 - Tsitsikamma Clinical Research Initiative
Cape Town, South Africa
Site 710003 - Office of Dr. ZFA Vawda MD
Durban, South Africa
Site 710004 - Synapta Clinical Research Center
Durban, South Africa
Site 710012 - CRISMO Research Centre
Germiston, South Africa
Site 710015 - University Of The Witwatersrand
Johannesburg, South Africa
Site 710006 - Langeberg Medicross Medical Centre
Kraaifontein, South Africa
Site 710002 - Lenmed- Ahmed Kathrada Private Hospital
Lenasia, South Africa
Site 710007 - Ubuntu Clinical Research
Lenasia, South Africa
Site 710001 - Emmed Research- Jakaranda Hospital
Pretoria, South Africa
Site 710009 - Global Clinical Trials
Pretoria, South Africa
Site 710011 - Busamed Paardevlei Hospital
Somerset West, South Africa
Site 710014 - University Of Stellenbosch
Stellenbosch, South Africa
Site 710010 - Limpopo Clinical Research Initiative
Thabazimbi, South Africa
Site 710008 - Welkom Clinical Trial Centre
Welkom, South Africa
Site 410003 - Hallym University Sacred Heart Hospital
Anyang-si, South Korea
Site 410012 - Chungbuk National University Hospital (CBNUH)
Cheongju-si, South Korea
Site 410004 - Jeonbuk National University Hospital
Jeonju, South Korea
Site 410001 - Konkuk University Medical Center
Seoul, South Korea
Site 410002 - The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, South Korea
Site 410005 - Korea University Guro Hospital
Seoul, South Korea
Site 410006 - Asan Medical Center (AMC)
Seoul, South Korea
Site 410007 - Kangbuk Samsung Hospital
Seoul, South Korea
Site 410008 - Severance Hospital, Yonsei University Health System
Seoul, South Korea
Site 410009 - Ajou University Hospital
Suwon, South Korea
Site 724005 - Clinica Mi Tres Torres Barcelona
Barcelona, Spain
Site 724008 - Hospital del SAS de Jerez de la Frontera
Jerez de la Frontera, Spain
Site 724007 - Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)
Madrid, Spain
Site 724002 - Servicio Andaluz de Salud Consejeria de Salud - Hospital Universitario Virgen de la Victoria
Málaga, Spain
Site 724004 - Hospital Universitario Marqués de Valdecilla
Santander, Spain
Site 724006 - Complejo Hospitalario Universitario De Santiago
Santiago de Compostela, Spain
Site 724003 - Hospital La Plana
Vila-real, Spain
Site 724001 - Hospital Universitario Miguel Servet
Zaragoza, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johann Christian VIRCHOW, Prof
Universitätsmedizin Rostock
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double (Participant, Investigator)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 8, 2023
Study Start
November 26, 2023
Primary Completion
December 9, 2025
Study Completion
December 9, 2025
Last Updated
December 18, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share