A 52-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis

TerminadoFase 3ClinicalTrials.gov

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

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

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