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 is for people with a long-term lung condition called Chronic Obstructive Pulmonary Disease (COPD), specifically those with chronic bronchitis. Researchers want to test new inhaled medicines (called CHF6001 DPI) alongside their usual triple therapy. They will compare these new medicines to a known treatment (Roflumilast) and a dummy medicine (placebo). The main goal is to find out if the new medicines can reduce the number of times people have bad flare-ups of their COPD over 52 weeks. They will also check if the new medicines improve breathing, symptoms like breathlessness and cough, and how participants feel overall.
At a glance
What is this study about?
This study is for individuals living with Chronic Obstructive Pulmonary Disease (COPD), especially if you also have chronic bronchitis. COPD makes it difficult to breathe, and chronic bronchitis means you often have a cough and mucus production. This research focuses on finding better ways to manage your condition.
The main aim of this study is to test a new inhaled medication, called CHF6001 DPI. Researchers want to see if this new medicine, when added to your current 'triple therapy' (which is a common combination of inhaled medications for COPD), can help reduce flare-ups of your COPD. Flare-ups are times when your symptoms suddenly get much worse, and they can be very worrying and sometimes require hospital visits.
Over 52 weeks (about one year), the study will compare two different doses of the new CHF6001 DPI with a well-known COPD medicine called Roflumilast (brand name Daliresp®) and also with a 'placebo' (a dummy medicine that looks like the real thing but has no active drug). By comparing these different options, the researchers hope to understand if the new CHF6001 DPI is safe and effective in lessening COPD flare-ups, improving your breathing, and generally making you feel better in your day-to-day life. All participants will be carefully monitored throughout the study.
Key takeaways
- Tests new inhaled medications for COPD with chronic bronchitis.
- Aims to reduce COPD flare-ups and improve breathing.
- Compares new drugs to existing treatment and a dummy medicine (placebo).
- Study lasts 52 weeks (about one year).
- Both men and women aged 18+ can take part.
- Careful monitoring of participants' health throughout.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older, and have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis.
There will be other, more detailed health requirements that a doctor will discuss with you. These are in place to make sure the study is right for your health condition and that it is safe for you to take part. For example, they might look at other medical conditions you have, or medicines you are currently taking, as these could affect your ability to participate.
Both men and women are welcome to take part in this research. Your study doctor will confirm if you meet all the necessary criteria after a thorough health check-up.
- Are you 18 years old or older?
- Have you been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)?
- Do you also have chronic bronchitis (a long-lasting cough with mucus)?
- Are you able to attend regular clinic appointments for about a year?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve regular visits to the clinic over a period of 52 weeks (about one year). During these visits, you’ll have various health checks, such as breathing tests to measure your lung function and assessments of your symptoms and how you're feeling. You would be given study medication to take, which will be either one of the new test medications, the existing Roflumilast medication, or a placebo (dummy medicine). You won't know which one you are taking. You might also be asked to keep a diary of your symptoms or how often you use your 'rescue' inhaler. After the 52 weeks, there will likely be a final follow-up appointment.
Potential risks and benefits
Locations (14)
- —Spain
- —Estonia
- —Austria
- —Slovakia
- —Croatia
- —Germany
- —Czechia
- —Poland
- —Bulgaria
- —Latvia
- —Netherlands
- —Hungary
+2 more sites — see the official record for the full list.
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease, a common lung condition that makes it hard for you to breathe.
What does 'chronic bronchitis' mean?
Chronic bronchitis means you have a persistent cough with a lot of mucus, often for many months in a year.
What is a 'placebo'?
A placebo is a dummy medicine that looks like the real treatment but contains no active drug. It helps researchers understand how much of the effect is due to the medicine itself.
How long will the study last?
The main part of the study where you take medication and have visits will last for 52 weeks, which is about one year.
Will I know which treatment I am receiving?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is over.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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