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RecruitingPHASE4INTERVENTIONAL

Identifying Predictors Of Response To Mepolizumab In CRSwNP

This research wants to understand why some patients with long-lasting nose polyps (CRSwNP) continue to feel much better for a long time after stopping treatment with a medicine called mepolizumab. Mepolizumab is an injection that helps reduce polyps and improve symptoms. While it's known to help, a small number of people experience lasting relief for years. This study aims to discover the biological reasons behind these long-term improvements and identify signs that could tell us in advance which patients are most likely to get this ongoing benefit. This could help doctors choose the best treatments for individual patients in the future.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrolment target
36
Start
03 Oct 2023
Estimated completion
31 Dec 2026

What is this study about?

This study is about a condition called Chronic Rhinosinusitis with Nasal Polyps, or CRSwNP. This is a long-term problem where soft, non-cancerous growths (nasal polyps) develop inside your nose and sinuses. This can cause various symptoms like a blocked nose, difficulty breathing, reduced sense of smell, and facial pain. Sometimes, these polyps need surgery, but they can often come back.

We are looking at a treatment called mepolizumab, which is a medicine given by injection. It's already approved for treating CRSwNP in some people. In previous studies, mepolizumab greatly improved symptoms and reduced the need for surgery. What's particularly interesting is that some patients have continued to feel much better for a very long time, even years, after they stopped taking the medicine. We don't fully understand why this happens or how to tell who will experience these long-lasting effects. Our study aims to uncover these answers, looking at how the medicine affects the body at a very detailed level.

By understanding why mepolizumab has such a lasting effect in some people, we hope to find ways to predict which patients are most likely to benefit the most. This could eventually help doctors make better decisions about who should receive this treatment and how long they might need it, potentially leading to more effective and personalised care for people living with CRSwNP. We will be studying patients closely to see how their bodies respond to the treatment and what might be different in people who experience longer-lasting improvements.

Key takeaways

  • Targets adults with severe, long-term nasal polyps.
  • Investigates why mepolizumab provides lasting relief for some patients.
  • Aims to find ways to predict who will benefit most from treatment.
  • Involves 12 months of mepolizumab injections and follow-up.
  • May offer significant symptom improvement.
  • Participation is voluntary; you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have ongoing, severe nasal polyps (CRSwNP). To join, you must have had nasal polyp surgery at least once in the last 10 years and your symptoms must be severe enough that you’d normally consider another surgery. You should also be using a steroid nasal spray or wash regularly.

There are also some reasons you wouldn't be able to join. For example, if you have certain other medical conditions like cystic fibrosis, or if you've recently had nasal surgery (within the last 6 months). Also, if you have an active infection or if the study doctor thinks it wouldn't be safe for you to participate, you wouldn't be eligible. If you've recently taken part in another clinical trial or received investigational treatments, this might also exclude 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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with bilateral nasal polyps?
  3. Have you had nasal polyp surgery within the last 10 years?
  4. Do you have severe nasal polyp symptoms that might need surgery?
  5. Are you currently using a steroid nasal spray or wash?
  6. Do you have ongoing symptoms like blocked nose, discharge, or reduced smell?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive mepolizumab injections for twelve months. This is an 'open-label' study, meaning both you and the study team will know you are receiving the active treatment. You will have regular appointments where the team will check your symptoms and the condition of your nose using a small camera (endoscopy). Before you start treatment and again after six months, more detailed tests will be done to understand how the treatment is working. The study lasts for twelve months of treatment, with further long-term check-ups to see if the benefits continue. The total duration of follow-up will be decided by the study team, but they will primarily assess the long-term effects through clinical check-ups.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a treatment that could significantly improve your nasal polyp symptoms and potentially lead to long-lasting relief, even after treatment stops. However, as with any medication, there are potential risks and side effects associated with mepolizumab, which your doctor will discuss with you. These could include reactions at the injection site or other effects on your body. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Centre Hospitalier de l'Université de Montréal (CHUM)
    Verified postcode
    Montreal, Canada· Recruiting

Common questions

What are nasal polyps?

Nasal polyps are soft, non-cancerous growths inside your nose and sinuses that can cause blockages and other symptoms.

What is mepolizumab?

Mepolizumab is a medicine given by injection, used to treat conditions like severe nasal polyps by targeting specific immune cells.

What does 'long-lasting response' mean in this study?

It means some patients continue to feel much better from their nasal polyps for a long time, possibly years, even after they stop taking mepolizumab.

Will I know if I'm getting the actual study drug?

Yes, this is an 'open-label' study, so you and the study team will know you are receiving mepolizumab.

What happens if I decide to leave the study early?

You are free to withdraw at any time for any reason, and your regular medical care will not be affected.

How to find out more

Martin Yvon Desrosiers, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Identifying Predictors Of Response To Mepolizumab In CRSwNP…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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