A randomised, double-blind, placebo-controlled, parallel group trial evaluating safety, tolerability, pharmacodynamics and pharmacokinetics of BI 1291583 one tablet once daily over 12 weeks versus placebo in adult patients with cystic fibrosis bronchiectasis (ClairaflyTM)
This research study is testing a new medication, a tablet known as BI 1291583, for adults living with cystic fibrosis bronchiectasis. The main goal is to understand if this new tablet is safe and well-tolerated by patients, meaning if it causes any unwanted side effects and how people feel taking it. We are also looking at how the medicine works in the body and how much of it gets absorbed. Participants will take the study medicine or a placebo (a dummy pill with no active ingredient) once a day for 12 weeks. We will then check for any side effects for up to 16 weeks after they start the treatment.
At a glance
What is this study about?
This study is exploring a new tablet called BI 1291583 for people who have both cystic fibrosis and bronchiectasis. Cystic fibrosis is a genetic condition that mainly affects the lungs and digestive system, leading to thick mucus. Bronchiectasis is a long-term condition where the airways of the lungs become abnormally wide, which can make them more vulnerable to infection and inflammation.
The main purpose of this study is to see if this new medication is safe and well-tolerated when taken once a day for 12 weeks. This means we'll be carefully monitoring for any side effects and how participants feel throughout the study. We also want to understand how the medicine behaves in the body – for example, how much of it gets absorbed and how long it stays in your system. This early stage of research, called Phase II, is crucial for gathering important information before potentially moving on to larger studies.
Participants will be randomly assigned to receive either the new BI 1291583 tablet or a placebo tablet (which looks exactly the same but contains no active medicine). This 'double-blind' approach means neither you nor your doctor will know which treatment you are receiving, which helps ensure the study results are as fair and accurate as possible. We will closely follow up with participants for up to 16 weeks after they start the medication to record any side effects.
Key takeaways
- Tests a new daily tablet (BI 1291583) for cystic fibrosis bronchiectasis.
- Compares the new medicine against a placebo (dummy pill).
- Focuses on safety and how well people tolerate the medicine over 12 weeks.
- Participants are adults, 18 years or older, with cystic fibrosis bronchiectasis.
- Involves regular clinic visits and follow-up for a total of 16 weeks.
- Your medical care won't be affected if you decide not to join, or withdraw later.
Who may be eligible?
This study is looking for adults who are 18 years old or older. Both men and women can take part. You must have a diagnosis of cystic fibrosis bronchiectasis.
There might be other health conditions or medications that would prevent someone from joining, as the researchers need to make sure the study is as safe as possible for everyone involved. For example, if you have certain other illnesses or are taking specific drugs, it might affect how the study medication works or increase potential risks.
It's very important to discuss your complete health history, all current medications (including over-the-counter and supplements), and any other medical conditions you have with the study team. They will be able to tell you if this trial is right for you.
- Are you 18 years old or older?
- Have you been diagnosed with cystic fibrosis bronchiectasis?
- Are you able to take a tablet once daily?
- Are you willing to attend regular clinic visits for up to 16 weeks?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two groups: one will receive the new medicine, BI 1291583, and the other will receive a dummy pill (placebo). Neither you nor your study doctor will know which one you are taking. You will take one tablet every day for 12 weeks.
Throughout the 12 weeks of treatment, you will have several clinic visits. These visits will involve various checks, such as physical examinations, blood tests, and possibly tests to see how your lungs are working. We will also monitor for any side effects you might experience. These assessments help the doctors understand how the medicine is affecting your body.
After you finish taking the study tablets, there will be follow-up visits or contact for another four weeks, bringing the total study duration to 16 weeks from when you first start the medication. These follow-up checks are important to make sure any late side effects are recorded. All travel to visits and the study medication will be provided.
Potential risks and benefits
Locations (6)
- —Belgium
- —Spain
- —France
- —Italy
- —Germany
- —Netherlands
Common questions
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but contains no active ingredients. It helps researchers compare the real medicine's effects.
What does 'double-blind' mean?
Double-blind means that neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps make the study fair and unbiased.
How long will I be taking the study medicine?
You will be taking the study medication or placebo once a day for 12 weeks.
What happens if I feel unwell during the study?
You should tell the study team immediately if you feel unwell or experience any new symptoms. They are there to support you throughout the trial.
Will I have to pay for anything if I join?
No, all study-related visits, tests, and the study medication will be provided at no cost to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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