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 important study is testing a new inhaler medicine called CHF6001 for people living with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis. All participants are already using a standard 3-in-1 inhaler. The aim is to see if adding CHF6001 helps to reduce the number and severity of breathing flare-ups (exacerbations) over a year. Researchers will also be checking if the new medicine improves breathing and overall quality of life. Some people will receive CHF6001, while others will receive a dummy inhaler (placebo), so we can fairly compare its effects. This is a common and necessary way to truly understand if a new medicine works and is safe.
At a glance
What is this study about?
Imagine living with a lung condition like COPD and chronic bronchitis, where your everyday breathing can be a struggle and sudden flare-ups make things even harder. This study, called a Phase 3 trial, is a big step in trying to find better ways to help people like you. We're investigating a new potential medicine, an inhaler called CHF6001. This medicine is designed to be added to the treatment you might already be using – a 'triple therapy' inhaler that combines three different medications.
The main goal of this study is to see if adding CHF6001 to your current treatment can reduce the number of times you experience a moderate or severe flare-up of your breathing difficulties over a 52-week period (about a year). Flare-ups can be very disruptive and sometimes require hospital visits, so finding a way to lessen them is really important. We also want to understand if CHF6001 can improve your breathing more generally, make you feel better day-to-day, and if it's safe to use.
To make sure we get clear results, some participants will receive the new CHF6001 inhaler, while others will receive a 'placebo' inhaler. This placebo looks exactly like the real medicine but doesn't contain any active drug. Neither you nor your study doctor will know which one you are getting, and this is standard practice in medical research to get the most accurate picture of the medicine's effects. We will carefully compare how both groups fare over the year to see if CHF6001 truly makes a difference.
Key takeaways
- This study is testing a new inhaler (CHF6001) for people with COPD and chronic bronchitis.
- It aims to reduce flare-ups and improve breathing when added to existing 3-in-1 inhaler treatment.
- The study lasts for about one year and involves regular clinic visits.
- Some participants will get the new medicine, others a dummy inhaler (placebo).
- Participation includes close medical monitoring and potential access to a new treatment.
Who may be eligible?
This study is looking for volunteers who are adults, aged 18 or older. There is no upper age limit, meaning older adults are also welcome to participate if they meet all other criteria. Both men and women can join.
To be considered for this study, you must have a diagnosis of both Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis. You will also need to be currently using a 'triple therapy' inhaler, which is an inhaler that contains three different active medicines to help manage your lung condition.
Beyond these main points, there will be other specific health checks and requirements that your study doctor will discuss with you. These are in place to ensure your safety and that the study results are as clear and reliable as possible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with both COPD and chronic bronchitis?
- Are you currently using a 'triple therapy' (3-in-1) inhaler for your lung condition?
- Are you willing and able to attend regular clinic visits for about a year?
What does participation involve?
If you decide to take part in this study, it will last for about a year (52 weeks). During this time, you will continue to use your regular 3-in-1 inhaler. You will also be given an additional study inhaler to use, which will either be the new medicine (CHF6001) or a placebo (a dummy inhaler).
You'll have regular visits to the study clinic where the team will monitor your health, check your breathing and other vital signs, and ask you questions about how you're feeling and how your symptoms are progressing. These checks might include breathing tests (like FEV1), questionnaires about your quality of life, and keeping a diary of your symptoms and any medications you use. These assessments help us understand how the treatment is affecting you and if it's making a difference to your condition.
Potential risks and benefits
Locations (12)
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedSlovakia
- —UnverifiedBulgaria
- —UnverifiedPoland
- —UnverifiedRomania
- —UnverifiedItaly
- —UnverifiedGreece
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedAustria
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung disease that makes it hard to breathe, often causing coughing, wheezing, and shortness of breath.
What is chronic bronchitis?
Chronic bronchitis is a type of COPD where the airways in your lungs are inflamed and produce a lot of mucus, leading to a long-lasting cough.
What does 'triple therapy' mean?
Triple therapy refers to an inhaler that contains three different medicines designed to help open up your airways and reduce inflammation in your lungs.
What is a 'placebo' in a study?
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine fairly.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you are receiving the active medicine or the placebo. This helps ensure fair and unbiased results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.