CHF6001 DPI
Sponsors
Chiesi Farmaceutici S.p.A.
Conditions
AsthmaCOPDChronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease (COPD)Chronic obstructive pulmonary disease (COPD) and Chronic Bronchitis
Phase 1
Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)
CompletedNCT04739774
Start: 2021-02-22End: 2021-04-26Updated: 2021-05-05
Effect of Erythromycin on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers
CompletedNCT06395610
Start: 2024-03-28End: 2024-06-18Updated: 2024-07-03
Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study
CompletedNCT06892756
Start: 2025-03-18End: 2025-06-20Updated: 2025-09-09
Phase 2
Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients
CompletedNCT01730404
Start: 2012-10-31End: 2013-10-31Updated: 2017-03-29
A 52-week, randomised, double blind, multicentre, 2-arm parallel group trial assessing the efficacy and safety of CHF6001 (total daily dose 3200 μg) Dry Powder Inhaler (DPI) add-on to maintenance medium or high dose inhaled corticosteroid in combination with long-acting ß2-agonists in subjects with uncontrolled asthma
CompletedCTIS2022-502208-64-00
Start: 2023-11-25End: 2025-12-09Target: 377Updated: 2025-09-29
A single-centre, single-dose, open label, non-randomized, parallel group, clinical pharmacology study of CHF 6001 in asthmatic adolescent patients and in asthmatic adult patients as control group
CompletedCTIS2024-516483-29-00
Start: 2025-03-24End: 2025-08-11Target: 50Updated: 2025-07-24
Phase 3
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.
CompletedCTIS2023-510175-60-00
Start: 2021-06-16End: 2025-06-18Target: 1216Updated: 2025-06-25
A 52-week, randomized, double-blind, double-dummy, placebo- and active- controlled (Roflumilast, Daliresp® 500μg), 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
CompletedCTIS2023-510174-13-00
Start: 2021-06-17End: 2025-12-16Target: 1019Updated: 2025-11-25