Predictive factors and magnitude of response to omalizumab and mepolizumab in allergic and eosinophilic severe asthma: PREDICTUMAB, an open-label, controlled, randomized multinational pragmatic trial.
This study, called PREDICTUMAB, is looking at two long-standing medications for severe asthma: omalizumab and mepolizumab. These drugs are used for people whose asthma is caused by allergies or by a type of white blood cell called eosinophils. The main goal is to compare how well omalizumab and mepolizumab prevent severe asthma attacks over one year. Researchers also want to understand who responds best to each treatment and if certain features, like age or other conditions, can predict this. It's a pragmatic study, meaning it aims to reflect real-world treatment experiences to help doctors and patients make better choices.
At a glance
What is this study about?
This study is designed to help people with severe asthma and their doctors understand which treatment might work best for them. If you have severe asthma, your doctor might have talked to you about medications like omalizumab or mepolizumab. These treatments are often used when standard inhalers aren't enough to control asthma symptoms.
The main purpose of this study is to compare these two important medicines. Researchers want to see if one is significantly better than the other at stopping severe asthma attacks, which can be very serious and sometimes need hospital care. They also want to identify what makes someone respond well to one drug but not the other. This could include looking at things like your age when your asthma started, if you have nasal polyps, or certain levels in your blood.
By gathering this information, the study hopes to provide clearer guidelines for doctors on how to choose the right treatment for each patient with severe allergic or eosinophilic asthma. This means that in the future, doctors might be able to predict more accurately which medication will give you the best results, leading to better asthma control and a better quality of life.
Key takeaways
- Compares two existing severe asthma medications: omalizumab and mepolizumab.
- Focuses on preventing severe asthma attacks over one year.
- Aims to understand which patients respond best to each drug.
- For adults (18+) with severe allergic or eosinophilic asthma.
- Participation lasts for one year with regular check-ups.
- Results could help doctors choose better treatments in the future.
Who may be eligible?
This study is looking for adults aged 18 and over who have been diagnosed with an advanced or severe form of asthma. This type of asthma can be either caused by allergies or by higher levels of a specific type of white blood cell called eosinophils (eosinophilic asthma).
Both men and women are welcome to take part in this study, as long as they meet the age and asthma criteria. The aim is to include a broad range of people to make the study results as helpful as possible for future patients.
To find out if you qualify, doctors will review your medical history and current asthma treatment. There will be specific medical checks to confirm if your asthma fits the study's requirements. It's important to discuss all your health conditions with the study team.
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 severe asthma?
- Is your severe asthma described as 'allergic' or 'eosinophilic'?
- Are you currently considering or receiving treatment with omalizumab or mepolizumab for your asthma?
What does participation involve?
If you join this study, you would be assigned to receive either omalizumab or mepolizumab, as decided by a process similar to chance. You would receive one of these medications and be carefully monitored by the study team over one year. This isn't a new drug trial; both medications are already approved and used for severe asthma.
During the study, you would have regular appointments to check how your asthma is doing. These appointments might involve questionnaires about your asthma symptoms and how it affects your daily life, breathing tests, and possibly blood or urine samples. For those with nasal polyps, there might be checks of your nasal passages.
The main goal during your participation is to track how often you experience severe asthma attacks and to measure how well your asthma is controlled. The total duration of your participation in the study would be one year.
Potential risks and benefits
Locations (2)
- —UnverifiedBelgium
- —UnverifiedFrance
Common questions
What kind of asthma is this study for?
This study is for people with severe asthma that is either caused by allergies or by high levels of 'eosinophils' (a type of blood cell).
Are the medications new?
No, omalizumab and mepolizumab are existing, approved medications for severe asthma that are already used by patients.
What will the study mainly measure?
The study will mainly look at how well each medication prevents severe asthma attacks over one year.
How long does the study last?
If you join, your participation, including receiving medication and follow-up, will last for one year.
Do I get to choose which medication I receive?
No, the medication you receive (omalizumab or mepolizumab) would be assigned in a way that helps researchers compare them fairly.
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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