A Phase 2b, Multicenter, Randomized, Double-blind, Parallel group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis
This study is looking for adults aged 18 to 85 with a lung condition called non-cystic fibrosis bronchiectasis. The aim is to test a new inhaled medicine, CSL787, to see if it can help reduce the number of flare-ups (when your symptoms get worse) and improve your overall breathing and quality of life. Some participants will receive the new medicine, while others will get a placebo (a dummy treatment without any medicine) to allow for a fair comparison. Researchers will also carefully monitor any side effects to make sure the medicine is safe. By taking part, you could contribute to understanding new treatments for this condition. Your doctor can provide more details if you are interested.
At a glance
What is this study about?
This research study is focused on a lung condition called non-cystic fibrosis bronchiectasis. This condition means your airways are widened and scarred, making them more prone to infections and flare-ups, where your breathing symptoms get worse. Researchers are looking for a new way to help manage this condition and reduce how often these flare-ups happen.
The study is testing a new medicine, CSL787, which is given through a nebuliser. This means you would breathe it in as a fine mist directly into your lungs. The main goal is to find out if this new medicine can delay or prevent the first flare-up you might experience during the study. They also want to see if it reduces the total number of flare-ups over a year and if it helps improve your breathing and overall quality of life.
To make sure the study gives reliable results, some participants will receive the new medicine, and others will get a 'placebo'. A placebo looks exactly like the medicine but contains no active drug. This allows researchers to compare the effects of the actual medicine against no treatment. Safety is also a top priority, so any side effects will be carefully recorded.
Key takeaways
- This study is testing a new inhaled medicine for non-cystic fibrosis bronchiectasis.
- It aims to see if the medicine reduces lung flare-ups and improves breathing.
- Some participants will receive the medicine, others a dummy treatment (placebo).
- Safety and side effects are carefully monitored throughout the study.
- Participation involves regular clinic visits and using a special inhaler.
Who may be eligible?
This study is looking for adults with non-cystic fibrosis bronchiectasis. You would need to be between 18 and 85 years old to take part. Both men and women are welcome to participate.
There might be other health conditions or medications that would prevent you from joining, as the researchers need to ensure the study is safe for everyone involved and that the results are clear. For example, if you have other severe lung or heart conditions, you might not be eligible.
Your doctor will discuss all the specific requirements with you to see if this study could be a good fit for your situation.
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 between 18 and 85 years old?
- Have you been diagnosed with non-cystic fibrosis bronchiectasis?
- Are you willing to regularly attend clinic visits?
- Are you able to use an inhaled nebuliser medicine?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to check if you meet all the criteria. If you are eligible, you would then be randomly assigned to either receive the new inhaled medicine (CSL787) or a placebo (a dummy treatment). You, your doctor, and the study team wouldn't know which one you are receiving.
Throughout the study, you would regularly attend clinic visits where the team would monitor your health, perform breathing tests, collect sputum (phlegm) samples, and ask you about your symptoms and any side effects. You would also use a nebuliser to take your study medication as prescribed. The study team will explain how and when to use this. They will be particularly interested in monitoring any flare-ups you might experience. The total duration of your participation in the study, including follow-up, would be discussed clearly at your initial visit.
Potential risks and benefits
Locations (10)
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedDenmark
- —UnverifiedNetherlands
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What is a 'nebuliser'?
A nebuliser is a device that turns liquid medicine into a fine mist so you can breathe it directly into your lungs.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps researchers compare effects.
What does 'non-cystic fibrosis bronchiectasis' mean?
It's a long-term lung condition where your airways are wider than normal and easily get infected, but it's not caused by cystic fibrosis.
What is a 'flare-up'?
A flare-up is when your usual breathing symptoms, like coughing and breathlessness, get noticeably worse and might need extra treatment.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study, meaning neither you, your doctor, nor the study team will know until 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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