Effect of Dupilumab on nasal epithelial barrier function in patients with Chronic Rhinosinusitis with nasal polyps (CRSwNP) – an exploratory pilot study
This research is an early-stage study (Phase IV) looking at how a treatment called Dupixent (which is already approved for use) affects the inside lining of the nose. It's for people who have chronic rhinosinusitis, especially those with nasal polyps. The main goal is to understand if Dupixent can improve the 'barrier function' of the nose lining. This barrier is like the skin inside your nose that protects it. Researchers will compare how this barrier changes in people with sinus problems before and after 6 months of Dupixent treatment, and also compare them to healthy people.
At a glance
What is this study about?
This study is called an 'exploratory pilot study,' which means it's one of the first studies to look into a particular idea. It's investigating how a medicine named Dupixent affects the lining inside your nose, specifically for people who suffer from a long-term condition called chronic rhinosinusitis. Some people with this condition also develop 'nasal polyps,' which are small, non-cancerous growths inside the nose.
The main aim of the study is to see if Dupixent can improve the 'barrier function' of the nasal lining. Think of your nose lining like a protective wall. In people with chronic rhinosinusitis, this wall might not be as strong as it should be, allowing irritants or infections to get through more easily. Researchers want to measure how strong this barrier is before treatment and again after six months of taking Dupixent. They will compare these measurements to see if the medicine helps make the barrier stronger.
This is a Phase IV study, which means Dupixent is already available and used for other conditions. This research helps us understand more about how it works specifically for chronic rhinosinusitis with nasal polyps, and whether it could be a good treatment option by strengthening the nose's natural defences. Understanding these changes at a very detailed level could lead to better treatments in the future.
Key takeaways
- This study investigates Dupixent for long-term sinus problems and polyps.
- It aims to understand if Dupixent strengthens the nose's protective lining.
- The study involves about 6 months of Dupixent treatment and clinic visits.
- It's for adults (18+) with chronic rhinosinusitis, with or without polyps.
- Participants will receive Dupixent and have detailed nasal assessments.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. Both men and women can take part.
You must have been diagnosed with chronic rhinosinusitis, which is a long-term inflammation of your sinuses. This includes people who have nasal polyps (small growths in the nose) and those who don't have polyps.
There might be other health requirements or reasons why you couldn't join, which the study team would discuss with you. They will check your medical history to make sure the study is safe and suitable for you.
- Are you 18 years old or older?
- Do you have a diagnosis of chronic rhinosinusitis (long-term sinus inflammation)?
- Have you been told you have nasal polyps, or do you have chronic rhinosinusitis without polyps?
- Are you prepared to attend regular clinic visits over approximately 6 months?
- Are you able to have injections and potentially small nasal biopsies?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would have a few visits to the study clinic over a period of about six months. Initially, there will be a baseline visit (Visit 1) where various assessments will be done before any treatment starts. You would then receive Dupixent, which is given as an injection, either from a pre-filled syringe or a pen. The study involves taking this medication over the six-month period.
Throughout the study, samples might be taken, such as small biopsies (tiny tissue samples) from your nasal lining, or fluids from your nose. These samples help researchers understand how your body is responding to the treatment at a very detailed level. You might also be asked to fill out questionnaires about your symptoms and how you feel, like the SNOT-22, which is a common way to track sinus-related quality of life. At the end of the six months (Visit 3), the same measurements will be repeated to see what changes have occurred.
Potential risks and benefits
Locations (1)
- —Austria
Common questions
What is chronic rhinosinusitis with nasal polyps?
It's a long-term condition where the lining of your nose and sinuses gets inflamed, often leading to growths called nasal polyps, stuffiness, and other symptoms.
What is Dupixent?
Dupixent is a medicine that helps reduce inflammation in the body. It's already used for conditions like severe asthma and eczema, and this study explores its use for chronic sinus problems.
Will I definitely get Dupixent in this study?
Yes, if you join this study, everyone will receive Dupixent. There is no placebo group in this particular study design.
What does 'barrier function' mean for my nose?
It refers to how well the inner lining of your nose acts as a protective shield against things like allergens, irritants, and germs.
How long will I be in the study?
The main treatment and assessment period for the study is about six months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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