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 research trial is for adults with asthma that's not well-controlled, even when they're using their regular inhalers (which contain steroids and long-acting bronchodilators). The main goal is to find out if adding a new inhaler called CHF6001 can help prevent asthma attacks over 52 weeks (about a year). Researchers also want to check how safe this new inhaler is. Participants will receive either the new inhaler or a dummy inhaler (placebo), alongside their current treatment. They will be monitored closely throughout the study to see how their asthma symptoms, lung function, and overall quality of life change.
At a glance
What is this study about?
This study is looking into a new inhaler treatment called CHF6001 for people who have asthma. If your asthma isn't fully under control, even though you're using your regular steroid and long-acting bronchodilator inhalers, then this study might be relevant to you. The main purpose is to see if adding CHF6001 to your current treatment can help reduce the number of asthma attacks you have over a 52-week period, which is about one year.
Researchers will also be carefully checking to make sure the new inhaler is safe to use and doesn't cause too many side effects. They will also look at other important things, like how well you can breathe, how much you need to use your reliever inhaler, and how your asthma symptoms affect your daily life. This type of study, called a Phase II trial, helps us learn more about how a new medication works and if it's promising enough for further testing.
By taking part, you would be helping doctors understand if CHF6001 could be a new option for managing asthma more effectively for people whose asthma is hard to control. The information gathered from this study will be used to decide if this new treatment should be tested in larger studies with more people.
Key takeaways
- Tests a new inhaler (CHF6001) for uncontrolled asthma.
- Compares CHF6001 to a dummy inhaler (placebo) for 52 weeks.
- Aims to reduce asthma attacks and assess safety.
- Open to adults aged 18 and over with uncontrolled asthma.
- Close medical monitoring throughout the study.
Who may be eligible?
This study is open to adults aged 18 and over. Both men and women can take part. The key requirement is that you must have asthma that isn't fully controlled by your current regular inhalers, which typically contain a steroid and a long-acting bronchodilator.
There might be other specific health conditions or medications that would prevent someone from joining, as is common in clinical trials. These detailed rules help make sure the study is as safe as possible for participants and that the results are clear.
If you're interested, you'd need to talk to a study doctor or nurse who can review your full medical history to see if you meet all the necessary criteria. They will be able to tell you if the study is a good fit for you.
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?
- Do you have asthma?
- Is your asthma not fully controlled by your current regular inhalers (steroid + long-acting bronchodilator)?
- Are you able to attend regular clinic appointments for about a year?
What does participation involve?
If you decide to take part in this study, it would last for about 52 weeks (one year). During this time, you would continue using your regular asthma medication, and also use either the new study inhaler (CHF6001) or a dummy inhaler (placebo) every day. You wouldn't know which one you are receiving – this is decided randomly, like flipping a coin.
You would have several visits to the study clinic over the year. During these visits, the study team would check your breathing using lung function tests, ask you about your asthma symptoms, how often you use your reliever inhaler, and how your asthma affects your daily life. They would also monitor you for any side effects and ensure you are taking your medication correctly.
Throughout the study, you would be provided with the study inhaler. It's important to attend all your scheduled appointments and keep track of your symptoms and reliever inhaler use as requested by the study team. You'll always have direct access to the study staff if you have any questions or concerns.
Potential risks and benefits
Locations (10)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedLatvia
- —UnverifiedHungary
- —UnverifiedBulgaria
- —UnverifiedLithuania
- —UnverifiedRomania
Common questions
What is CHF6001?
CHF6001 is a new inhaler treatment being tested to see if it can help people with asthma that is not fully controlled by their current medications.
How long does the study last?
The study lasts for 52 weeks, which is about one year.
Will I know if I'm getting the new inhaler or a dummy inhaler?
No, neither you nor the study team will know. This is to make sure the results are fair and unbiased.
What kind of asthma do I need to have to join?
You need to have asthma that isn't fully controlled, even with your regular inhalers that contain steroids and long-acting bronchodilators.
What would I have to do if I join?
You would take the study inhaler daily, attend regular clinic visits for checks, and report your symptoms and medication use to the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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