AzTrials
AzTrials

Uncontrolled AsthmaPhase 2TANGONCT06029595

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

A Phase 2 study testing Experimental: CHF6001 3200 μg in people with Uncontrolled Asthma, run by Chiesi Farmaceutici S.p.A. at 187 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Uncontrolled Asthma
What is being tested?
Experimental: CHF6001 3200 μg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
517 participants
Where
187 sitesin 14 countries
Study dates
26 Nov 2023to 9 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • Drugs with hepatoxicity potential
  • Subjects with contra-indications to IMPs:
  • Subjects with history alcohol/drug abuse
  • Subjects with major surgery in the 3 months prior to screening visit or planned during the trial
  • Subjects treated with non-potassium sparing diuretics, nonselective β-blocking drugs, quinidine, quinidine like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation
  • Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic anti-depressants
  • Subjects receiving any therapy that could interfere with the study drugs
  • Participation in another investigational trial
  • Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks
  • Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
  • For females only: pregnant or lactating women

Trial locations and contacts

187 sites in 14 countries.

187 sites in 14 countries

Argentina32 sites

  • 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 032005 - National University of Cordoba - Rusculleda Foundation - Instituto DAMIC

    Córdoba

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

    Corrientes

  • Site 032010 - Centro Platense en Investigaciones Respiratorias - CEPIR

    La Plata

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

    Lanus

  • 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 032020 - Instituto Especialidades de la Salud Rosario - Clinica del Torax

    Santa Fe, La

  • 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

Other trials in Argentina

Bulgaria29 sites

  • 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

Other trials in Bulgaria

Poland23 sites

  • 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 616005 - Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poradnia Chorob Pluc

    Słupsk

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

    Strzelce Opolskie

  • 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

Other trials in Poland

Germany21 sites

  • 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

Other trials in Germany

South Africa16 sites

  • 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

Other trials in South Africa

Czechia10 sites

  • 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

Other trials in Czechia

South Korea10 sites

  • 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

Other trials in South Korea

Romania9 sites

  • 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

Other trials in Romania

Spain8 sites

  • 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

Other trials in Spain

Georgia7 sites

  • 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

Other trials in Georgia

Latvia7 sites

  • 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

Other trials in Latvia

Italy6 sites

  • 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

Other trials in Italy

Hungary5 sites

  • 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

Other trials in Hungary

Lithuania4 sites

  • 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

Other trials in Lithuania

About this study

Official title: 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

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)

Being tested
Experimental: CHF6001 3200 μg, Placebo Comparator: CHF6001 Placebo
Keywords
Asthma, PDE4 inhibitor, anti-inflammatory respiratory drug, Tanimilast
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: CHF6001 3200 μgDrug

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

  • Placebo Comparator: CHF6001 PlaceboDrug

    2 inhalations of CHF6001 matching placebo BID

Study groups in NCT06029595
Study groupRoleWhat they receive
CHF6001 - CHF6001 total daily dose 3200 μg;ExperimentalNot described
Receives: Drug: Experimental: CHF6001 3200 μg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo Comparator: CHF6001 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Over 52 weeks

Secondary outcomes (11)

  1. Time to first asthma exacerbation;

    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

    Measured: Up to 52 weeks

  2. Number of asthma exacerbation and asthma worsening 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; Asthma worsening defined as moderate asthma exacerbation.

    Measured: Up to 52 weeks

  3. Time to first asthma exacerbation or asthma worsening

    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; Asthma worsening defined as moderate asthma exacerbation.

    Measured: Up to 52 weeks

  4. ACQ-7 responders

    ACQ-7 responders at Week 4, Week 26 and Week 52 (i.e., subjects showing improvement from baseline in ACQ-7 score of ≥0.5 units);

    Measured: week 4, week 26 and week 52

  5. Change from baseline in ACQ-7 and ACQ-6

    Change from baseline in ACQ-7 and ACQ-6 at Week 4, Week 26 and Week 52

    Measured: week 4, week 26 and week 52

  6. Change from baseline in Mini-AQLQ

    Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52

    Measured: week 4, week 26 and week 52

  7. Change from baseline in pre-dose FEV1

    Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52;

    Measured: week 4, week 26 and week 52

  8. Change from baseline in pre-dose FVC

    Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26;

    Measured: Week4, Week 52 and Week 26

  9. Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF;

    Measured: Up to 52 weeks

  10. Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score

    Measured: Up to 52 weeks

  11. Change from baseline to each inter-visit period and to the entire treatment period in the percentage of rescue medication-free days, asthma symptoms-free days and asthma control days.

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start26 Nov 2023
  3. Primary completion9 Dec 2025
  4. Study completion9 Dec 2025

Why it stopped: Strategic decision by Sponsor; not due to safety reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, double-blind, placebo-controlled, 2-arm parallel group study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029595
Sponsor's protocol ID
CLI-06001AA2-01
Other IDs
EUCT: 2022-502208-64-00
Acronym
TANGO
Status last verified
Mar 2025
First submitted
31 Aug 2023
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Experimental: CHF6001 3200 μg in people with Uncontrolled Asthma, run by Chiesi Farmaceutici S.p.A. at 187 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in Argentina, Bulgaria, Poland, Germany, South Africa and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic decision by Sponsor; not due to safety reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Asthma exacerbation over 52 weeks of treatment (time frame: Over 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06029595.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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