Este estudio evaluará la eficacia y seguridad de astegolimab en comparación con placebo en participantes con enfermedad pulmonar obstructiva crónica (EPOC) que son fumadores actuales o ex fumadores y tienen antecedentes de exacerbaciones frecuentes.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Documented COPD diagnosis for ≥ 12 months
History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
Post-bronchodilator FEV1 ≥ 20% and \< 80% of predicted at screening
Post-bronchodilator FEV1/FVC \< 0.70 at screening
Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD

Criterios de exclusión

Current documented diagnosis of asthma
History of clinically significant pulmonary disease other than COPD
Diagnosis of 1-antitrypsin deficiency
History of long-term treatment with oxygen at \> 4.0 liters/minute
Lung volume reduction surgery or procedure within 12 months prior to screening
Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
History of lung transplant
Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
Upper or lower respiratory tract infection within 4 weeks prior to or during screening
Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Ubicaciones

Consultorios Medicos Organizacion de Buen Ayre SRL

Buenos Aires, Argentina

COMPLETED

Nexo Salud Investigacion Clinica - Riobamba 429

Buenos Aires, Argentina

COMPLETED

CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC

Buenos Aires, Argentina

COMPLETED

Fundacion Faicep

Buenos Aires, Argentina

COMPLETED

Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias

Buenos Aires, Argentina

COMPLETED

AES - AS - Glenny Corp. S.A. Buenos Aires

Buenos Aires, Argentina

COMPLETED

Centro de Medicina Respiratoria

Concepción del Uruguay, Argentina

COMPLETED

Sanatorio de la Canada

Córdoba, Argentina

COMPLETED

Framingham Centro Medico

La Plata, Argentina

COMPLETED

Centro Medico Capital

La Plata, Argentina

COMPLETED

Centro Platense en Investigaciones Respiratorias

La Plata, Argentina

COMPLETED

Centro Medico Dharma

Mendoza, Argentina

COMPLETED

Centro Privado de Medicina Respiratoria

Paraná, Argentina

COMPLETED

Sala de primeros auxilios Alberto Mignaburu

Ranelagh, Berazategui, Argentina

COMPLETED

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

COMPLETED

Servicio de Investigacion de Patologias Alergicas-Instituto ABC

Rosario, Argentina

COMPLETED

Sanatorio Parque de Rosario

Rosario, Argentina

COMPLETED

Centro Modelo de Cardiologia

San Miguel de Tucumán, Argentina

COMPLETED

Centro Medico San Nicolas Grupo Orono

San Nicolás de los Arroyos, Argentina

COMPLETED

CEPROSS- Centro Profesional San Salvador

San Salvador, Argentina

COMPLETED

Instituto Del Buen Aire

Santa Fe, Argentina

COMPLETED

Centro de Diagnostico Y Rehabilitacion

Santa Fe, Argentina

COMPLETED

Un Estudio Multicéntrico de Fase III, Aleatorizado, Doble Ciego, Controlado con Placebo, para Evaluar la Eficacia y Seguridad de Astegolimab en Pacientes con Enfermedad Pulmonar Obstructiva Crónica

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Astegolimab

Placebo

Ubicaciones

Consultorios Medicos Organizacion de Buen Ayre SRL

Nexo Salud Investigacion Clinica - Riobamba 429

CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC

Fundacion Faicep

Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias

AES - AS - Glenny Corp. S.A. Buenos Aires

Centro de Medicina Respiratoria

Sanatorio de la Canada

Framingham Centro Medico

Centro Medico Capital

Centro Platense en Investigaciones Respiratorias

Centro Medico Dharma

Centro Privado de Medicina Respiratoria

Sala de primeros auxilios Alberto Mignaburu

Instituto Medico de la Fundacion Estudios Clinicos

Servicio de Investigacion de Patologias Alergicas-Instituto ABC

Sanatorio Parque de Rosario

Centro Modelo de Cardiologia

Centro Medico San Nicolas Grupo Orono

CEPROSS- Centro Profesional San Salvador

Instituto Del Buen Aire

Centro de Diagnostico Y Rehabilitacion

Patrocinadores

Contactos

Reference Study ID Number: GB44332 https://forpatients.roche.com/