A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe eosinophilic asthma (EXHALE-3)
This research study is testing a new medicine called dexpramipexole for people who have severe eosinophilic asthma. This is a type of asthma where a specific kind of white blood cell, called eosinophils, can cause a lot of inflammation in the airways. The study aims to find out if this new medicine can help reduce severe asthma attacks (also called exacerbations) over a year, and if it improves lung function and quality of life. Participants will take either the new medicine or a dummy medicine (placebo), and neither they nor their doctors will know which one they are getting. Safety and any side effects of the medicine will also be carefully checked. The goal is to see if dexpramipexole could be a helpful new treatment option.
At a glance
What is this study about?
This study is called EXHALE-3 and focuses on a new medicine, dexpramipexole, for a specific type of asthma known as severe eosinophilic asthma. In simple terms, this is asthma that's hard to control and often involves too many of certain immune cells (called eosinophils) that can make your airways very inflamed.
The main goal of the study is to see if taking dexpramipexole for 52 weeks can reduce the number of severe asthma flare-ups (when your asthma suddenly gets much worse and you might need emergency treatment). We also want to find out if it helps you breathe better and improves your overall quality of life.
To make sure the results are reliable, some participants will receive the new medicine, while others will receive a 'dummy' medicine (placebo) that looks exactly the same but contains no active drug. This is done so we can clearly see if any improvements are due to the new medicine itself. Both you and your study doctor won't know which one you're taking until the study is over, which helps keep the trial fair and unbiased.
Key takeaways
- Tests a new medicine (dexpramipexole) for severe eosinophilic asthma.
- Aims to reduce asthma flare-ups and improve breathing.
- Compares the new medicine to a dummy medicine (placebo).
- Study lasts for approximately 52 weeks.
- Open to adults aged 18 and over.
- Safety and side effects are carefully monitored.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old – there's no upper age limit. The study is open to both men and women.
Crucially, you must have severe eosinophilic asthma. This means your asthma is quite serious and is linked to high levels of specific cells called eosinophils. The study team will check your medical records and perform tests to confirm that your asthma fits this description.
There might be other health conditions or medications that would prevent you from joining, to ensure everyone's safety. The study team will discuss all of these with you in detail to see if this study is suitable 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 severe eosinophilic asthma?
- Are you able to attend regular clinic visits for about a year?
- Are you willing to potentially receive a dummy medicine?
- Are you comfortable with the possibility of developing side effects?
What does participation involve?
If you decide to take part, you'll be in the study for about a year (52 weeks). During this time, you would regularly attend clinic visits where doctors and nurses will monitor your health, check your asthma symptoms, and perform breathing tests. You would take the study medicine (either dexpramipexole or the placebo) as instructed.
You'll also be asked to keep track of your asthma symptoms and how well you're feeling. There will be questionnaires to fill out that help us understand how your asthma affects your daily life. Throughout the study, you'll continue to use your standard 'reliever' inhalers (like Ventolin) as needed, and other asthma medications if your study doctor agrees they are safe to use with the trial medicine. There will be regular follow-up appointments to ensure your safety and track any changes.
Potential risks and benefits
Locations (9)
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedLithuania
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedCroatia
Common questions
What is eosinophilic asthma?
It's a type of asthma where a specific kind of white blood cell, called eosinophils, are too high and cause a lot of irritation and swelling in your airways.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you are receiving the new medicine or a dummy medicine (placebo). This helps make the study fair.
Will I still use my regular asthma inhalers?
Yes, you will continue to use your regular reliever inhalers (like Ventolin) as needed, and other approved asthma medicines, alongside the study treatment.
How long will the study last?
The main treatment part of the study will last for 52 weeks, which is about one year. There might be some follow-up appointments after that.
What if my asthma gets worse during the study?
Your health will be closely monitored throughout the study. If your asthma or any other health issue worsens, the study team will provide care and discuss the best steps, which might include leaving the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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