A 12-week double-blind, multicentre, randomised, active-controlled, 2-arm, parallel-group clinical trial to evaluate the safety of CHF5993 pMDI 200/6/12.5 µg HFA-152a, compared to CHF5993 pMDI 200/6/12.5 µg HFA-134a, in subjects with asthma
This 12-week study is looking at a new version of an asthma inhaler called CHF5993. It's for adults aged 18 and older who have moderate to severe asthma that is already being managed. The main goal is to check the safety of the new inhaler and compare it with the current version. Researchers will also look at how well the new inhaler helps people breathe, how often they need their reliever inhaler, and any changes in their asthma symptoms. This type of study (Phase III) is important for confirming that new medicines are safe and effective before they can be widely used.
At a glance
What is this study about?
This clinical trial is designed to investigate a new version of an asthma inhaler medication, known as CHF5993. If you have moderate to severe asthma, you might be interested in how new treatments are developed. The study aims to make sure this updated inhaler is safe for people to use. It's a 'Phase III' study, which means it's one of the final steps before a new medicine can be considered for general use. These studies are crucial for confirming that the new version works as expected and is as safe as, or even safer than, what's currently available.
The study will last for 12 weeks and involves comparing the new version of the inhaler with an existing one. For asthma sufferers, good control of symptoms is vital. Researchers will be monitoring several aspects to see how well the new inhaler performs. This includes measuring lung function (how easily you can breathe out air), tracking if you need rescue medication, and noting any changes in your daily asthma symptoms. They're also keeping a close eye on any side effects.
The overall purpose is to gather enough evidence to show that the new CHF5993 inhaler is a safe and effective treatment option for adults with moderate to severe asthma. This helps ensure that patients have access to the best possible care for their condition.
Key takeaways
- The study tests a new version of an asthma inhaler (CHF5993) for safety.
- It involves adults (18+) with moderate to severe asthma.
- It compares the new inhaler to an existing one over 12 weeks.
- Researchers will monitor breathing, symptoms, rescue inhaler use, and side effects.
- Participation involves regular clinic visits and health checks.
- You have the right to leave the study at any time.
Who may be eligible?
This study is looking for volunteers who are 18 years old or older. You can be male or female.
To join, you must have moderate to severe asthma. This means your asthma symptoms are significant, even with your current treatment. Your doctor will use specific guidelines (GINA 2022) to confirm if your asthma fits this description.
Basically, if you're an adult with asthma that needs regular management and you wish to explore new treatment options under close medical supervision, you might be suitable for this study.
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 moderate to severe asthma?
- Is your asthma currently managed with regular medication?
- Are you willing to attend regular clinic visits for 12 weeks?
- Are you able to use an inhaler correctly as instructed?
What does participation involve?
If you decide to take part in this study, you would use one of the two inhalers (either the new version or the existing one) for 12 weeks. Neither you nor your study doctor would know which one you are using – this is called 'double-blind' and helps ensure unbiased results.
You would have several visits to the clinic over the 12-week period. At these visits, you would have your breathing tested (specifically, how much air you can force out in one second, called FEV1), and researchers would ask about your asthma symptoms, how often you use your rescue inhaler, and any side effects you might be experiencing. We would also check your overall health through things like blood pressure, heart rate, and possibly blood tests or heart tracings (ECGs). You would be given instructions on how to properly use your inhaler and what to look out for. The total duration of your active involvement in the treatment part of the study would be 12 weeks.
Potential risks and benefits
Locations (11)
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedCzechia
- —UnverifiedGreece
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedRomania
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedSlovakia
Common questions
What is FEV1?
FEV1 stands for 'Forced Expiratory Volume in 1 second'. It's a common breathing test that measures how much air you can forcefully blow out of your lungs in one second.
What does 'double-blind' mean?
Double-blind means that neither you nor your study doctor will know whether you are receiving the new inhaler or the existing one. This helps ensure the results are fair and objective.
What is 'moderate to severe controlled asthma'?
This means your asthma is significant enough to require ongoing treatment, and even with your current management, you may still experience symptoms that impact your daily life, fitting specific medical guidelines.
Will I have to pay to participate?
No, you should never have to pay to participate in a clinical trial. All study medications and clinic visits related to the trial will be covered.
Can I leave the study if I change my mind?
Yes, your participation is completely voluntary, and you can withdraw from the study at any time without giving a reason, and without it affecting your regular medical care.
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.