- Ongoing, recruitingTherapeutic exploratory (Phase II)
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
This study looks at a new inhaler, CHF6001, for people with asthma that isn't fully controlled. Researchers want to see if adding this new inhaler to their usual medication helps reduce asthma attacks over 52 weeks and is safe.
For: AsthmaItaly · Spain · Czechia - Ongoing, recruitingTherapeutic confirmatory (Phase III)
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.
This study is looking at a new medicine called CHF6001. It's for people with COPD and chronic bronchitis who are already using a 3-in-1 inhaler. We want to see if adding CHF6001 helps reduce flare-ups and improve breathing and quality of life over a year.
For: Chronic obstructive pulmonary disease (COPD) and Chronic BronchitisHungary · Germany · Slovakia - Ongoing, recruitingTherapeutic confirmatory (Phase III)
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
This study looks at new inhaled medications for people with a type of lung disease called COPD. It aims to see if these new medicines can help reduce flare-ups, improve breathing, and make everyday life better.
For: Chronic Obstructive Pulmonary Disease (COPD)Spain · Estonia · Austria - Ongoing, recruitingTherapeutic exploratory (Phase II)
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
This study is testing a new asthma medicine, CHF 6001, in teenagers and adults with asthma. Researchers want to see how the body handles the medicine and how safe it is. It's an early-stage study to understand the medicine better.
For: AsthmaBulgaria