Estudio de 52 Semanas, Aleatorizado, Doble Ciego, Controlado con Placebo, de Grupos Paralelos para Evaluar la Eficacia y Seguridad de Dos Dosis de CHF6001 DPI como Terapia Complementaria al Tratamiento de Mantenimiento Triple en Sujetos con Enfermedad Pulmonar Obstructiva Crónica (EPOC) y Bronquitis Crónica

TerminadoFase 3ClinicalTrials.gov

ID: NCT04636801Tipo: INTERVENTIONALInicio: 14 de jul de 2021Fin estimado: 31 de oct de 2025

Resumen

El propósito del estudio es evaluar la eficacia y seguridad de dos dosis de CHF6001 (Tanimilast) como terapia complementaria al tratamiento de mantenimiento triple en la población de pacientes objetivo.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Adults aged ≥ 40 years with COPD and chronic bronchitis
Current or ex-smokers (history ≥ 10 pack years).
Post-bronchodilator FEV1 \<60% of the subject predicted normal value and FEV1/FVC ratio \< 0.7.
At least, one moderate or severe COPD exacerbation in previous year.
CAT score ≥ 10
Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit

Criterios de exclusión

Subjects with current asthma.
Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.
Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
Subjects with COPD emphysema or mixed phenotypes.
Subjects with known respiratory disorders other than COPD.
Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy.
Subjects under Roflumilast treatment within 6 months before study entry.
Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
Subjects with clinically significant cardiovascular.
Subjects with a significant neurological disease.
Subjects with clinically significant laboratory abnormalities.
Subjects with moderate or severe hepatic impairment

Intervenciones

drug

Experimental: CHF6001 1600µg

CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).

drug

Experimental: CHF6001 3200µg

CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).

drug

Placebo

CHF6001 matching placebo, 2 inhalations bid.

Ubicaciones

Chiesi Clinical Trial - Site 32415

Buenos Aires, Argentina

Chiesi Clinical Trial - Site 32407

Buenos Aires, Argentina

Chiesi Clinical Trial - Site 32410

Buenos Aires, Argentina

Chiesi Clinical Trial - Site 32454

Buenos Aires, Argentina

Chiesi Clinical Trial - Site 32457

Caba, Argentina

Chiesi Clinical Trial - Site 32459

CABA, Argentina

Chiesi Clinical Trial - Site 32414

Ciudad Autonoma de Buenos Aire, Argentina

Chiesi Clinical Trial - Site 32403

Córdoba, Argentina

Chiesi Clinical Trial - Site 32409

Córdoba, Argentina

Chiesi Clinical Trial - Site 32401

Florida, Argentina

Centro de Medicina Respiratoria - Concepcion del Uruguay - site 32463

Forestal Entre Ríos, Argentina

Chiesi Clinical Trial - Site 32455

La Plata, Argentina

Chiesi Clinical Trial - Site 32458

Mar del Plata, Argentina

Chiesi Clinical Trial - Site 32462

Mar del Plata, Argentina

Chiesi Clinical Trial - Site 32405

Mendoza, Argentina

Chiesi Clinical Trial - Site 32411

Mendoza, Argentina

Chiesi Clinical Trial - Site 32413

Mendoza, Argentina

Chiesi Clinical Trial - Site 32402

Monte Grande, Argentina

Chiesi Clinical Trial - Site 32406

Quilmes, Argentina

Chiesi Clinical Trial - Site 32453

Rosario, Argentina

Chiesi Clinical Trial - Site 32460

San Fernando, Argentina