A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 24 weeks in participants with eosinophilic asthma (EXHALE-4)
This study, named EXHALE-4, is looking into a new medicine called dexpramipexole for a specific type of asthma known as eosinophilic asthma. It's a key stage 3 trial, meaning we're confirming if the medicine works well and is safe before it can be widely used. For 24 weeks, adult participants will take either the new medicine or a dummy pill (placebo) every day. We'll be carefully checking their breathing, how well their asthma is controlled, and their overall quality of life. The main goal is to see if the medicine helps improve lung function, specifically how much air they can breathe out in one second. We'll also be monitoring for any side effects to make sure it's well-tolerated.
At a glance
What is this study about?
This research study, called EXHALE-4, is about a new medicine named dexpramipexole. It's specifically for people who have a type of asthma called eosinophilic asthma. In this type of asthma, there's a higher level of certain white blood cells called eosinophils in the airways, which can make asthma symptoms worse and harder to control. We want to find out if this new medicine can help improve breathing and make living with eosinophilic asthma easier.
This is a 'Phase 3' study, which is an important step in testing new medicines. It means we're trying to confirm that the medicine is both effective (it works) and safe for people to use, especially compared to a dummy pill (placebo). Half of the participants will receive the new medicine, and the other half will receive a placebo, but no one will know which they are taking until the study ends. This helps us ensure the results are accurate and unbiased.
The main thing we'll be looking at is how much a person's breathing improves. We'll measure how much air you can blow out in one second (this is called FEV1) at the start and then again towards the end of the study. We'll also check how well your asthma is controlled, using questionnaires about your symptoms, and how your asthma impacts your daily life.
Key takeaways
- This study is testing a new medicine for eosinophilic asthma.
- It's a Phase 3 study, confirming if the medicine works and is safe.
- Participants will take either the new medicine or a dummy pill for 24 weeks.
- The main goal is to see if the medicine improves breathing (FEV1) and asthma control.
- All adults aged 18 and over with eosinophilic asthma may be eligible.
- Regular clinic visits and health checks are part of taking part.
Who may be eligible?
This study is open to adults aged 18 years and older. There is no upper age limit, so older adults can also take part. Both men and women are welcome to join.
To be considered for the study, you must have been diagnosed with eosinophilic asthma. The study team will check your medical history and run some tests to make sure that you meet all the specific requirements for this particular type of asthma.
It's important to remember that even if you meet these general criteria, there might be other specific health conditions or medications that could prevent you from participating safely. The study team will discuss all the detailed requirements with you before you make any decisions.
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 eosinophilic asthma?
- Are you able to take medicine by mouth every day?
- Are you able to attend regular clinic appointments for about 6 months?
What does participation involve?
If you decide to take part in this study, it will last for a total of 24 weeks, which is about six months. You'll be asked to take the study medicine (or a dummy pill) by mouth every day. You won't know if you're getting the active medicine or the dummy pill, and neither will the study staff; this is to make sure the results are as fair as possible.
During these 24 weeks, you'll have several visits to the clinic. These visits will involve various assessments, such as breathing tests (like the FEV1 test), answering questionnaires about your asthma symptoms and how they affect your life, and having blood samples taken. These tests help us understand if the medicine is working and how you're feeling.
The study team will monitor your health closely throughout the 24 weeks to ensure your safety and check for any side effects. After the 24 weeks, there might be a final follow-up visit or call to make sure everything is okay.
Potential risks and benefits
Locations (2)
- —UnverifiedRomania
- —UnverifiedPoland
Common questions
What is eosinophilic asthma?
It's a type of asthma where a particular white blood cell, called an eosinophil, is present in higher numbers in your airways. This can make asthma symptoms more severe.
What is a 'dummy pill' or placebo?
A dummy pill looks exactly like the study medicine but contains no active drug. It helps researchers understand if the new medicine is truly effective or if improvements are due to other factors.
Will I know if I'm getting the real medicine or the dummy pill?
No, during the study, neither you nor the study team will know. This is called 'double-blind' and is done to keep the results fair and unbiased.
How long will I be in the study?
If you join, your participation will last for 24 weeks, which is about six months.
What does FEV1 mean?
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 and helps assess your lung function.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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