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)

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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
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

Ubicaciones

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Experimental: CHF6001 3200 μg

Placebo Comparator: CHF6001 Placebo

Ubicaciones

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

Site 032027- Centro de Medicina Respiratoria

Site 032025 - Sala Mignaburu

Site 032004 - CARE - Centro de Alergia y Enfermedades Respiratorias

Site 032008 - Mautalen Salud e Investigacion

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

Site 032021 - Centro De Investigaciones Medicas Mar Del Plata

Site 032024 -CEMLO- Consultorio Medico CEMLO LOBOS

Site 032029 - Hospital de Alta Complejidad del Bicentenario de Esteban Echeverría

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

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

Site 032032 - Hospital Italiano de Buenos Aires (HIBA)

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

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

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

Site 032010 - Centro Platense en Investigaciones Respiratorias - CEPIR

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

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

Site 032002 -Consultorios Medicos Dr Isaac Scherbovsky - Fundacion Scherbovsky

Site 032009 - Centro Medico INSARES

Site 032023 - Respira Salud Clinica Integral

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

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

Site 032016 - Instituto Medico de la Fundacion Estudios Clinicos

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

Site 032001 - Instituto de Enfermedades Respiratorias e Investigacion Medica- IERIM

Site 032015 - Fundacion de Estudios Clinicos de Consultorio Integrados Rosario

Site 032018 - Instituto de Investigaciones en Patologias Respiratorias

Site 032022 - Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

Site 032012 - Instituto Del Buen Aire

Site 032028 - Instituto De Investigaciones Clnicas De Rosario

Site 032017 - Centro Medico de Enfermedades Respiratorias (CEMER)

Patrocinadores