Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A phase IV, randomized double blinded placebo-controlled study on the barrier restoring capacity of Dupilumab in type 2 airway disease: CRSwNP

This important study is investigating a medicine called Dupixent (Dupilumab) for people who suffer from chronic rhinosinusitis with nasal polyps. This is a condition that causes ongoing stuffiness, discharge, and often small growths in the nose. We're specifically looking at whether Dupixent can help to strengthen the natural protective lining inside the nose. Think of this lining as a wall that protects against irritants; we want to see if Dupixent helps repair it. Participants will receive either Dupixent or a look-alike dummy medicine (placebo) for 24 weeks. Researchers will collect information over this time to understand how the treatment affects the nose and other health markers, and how patients feel about their symptoms.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

UZ Leuven

Enrolment target

Start

23 Jun 2023

chronic rhinosinusitis with nasal polyps

What is this study about?

This study is all about understanding how a medicine called Dupixent (which is also known as Dupilumab) works for people who have a condition called chronic rhinosinusitis with nasal polyps (CRSwNP). This is a fancy name for a long-lasting inflammation in the nose and sinuses, often with non-cancerous growths called nasal polyps. These polyps can cause symptoms like a blocked or runny nose, loss of smell, and facial pain or pressure.

Dupixent is already a licensed medicine for some conditions. In this study, we are researching it further to see if it can help fix the natural barrier in the lining of the nose. Imagine the lining of your nose as a protective wall; sometimes, in conditions like CRSwNP, this wall might not be as strong as it should be. We want to see if Dupixent can help repair and strengthen this wall. This is a 'Phase IV' study, which means the medicine is already approved for some uses, and this research is looking deeper into how it works and its effects.

To find this out, participants will receive either Dupixent or a matching dummy medicine (placebo) without knowing which one they have. Over 24 weeks, the study team will collect samples and information to understand changes in the nose lining at a very detailed level, checking how genes behave and looking at specific proteins. We'll also measure other things like inflammation in the blood and, very importantly, how people feel about their symptoms and quality of life, including their sense of smell and breathing.

Key takeaways

This study evaluates Dupixent for chronic nasal polyps.
It aims to see if Dupixent strengthens the nose's protective lining.
You might receive Dupixent or a dummy medicine (placebo).
Participation involves regular visits and assessments over 24 weeks.
The study also measures how symptoms improve and impact your daily life.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part.

You would typically be considered if you have been diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP). The study team will check your full medical history and current health to make sure the study is safe and suitable for you.

There might be other health conditions or medications that would prevent you from joining, as the research team needs to ensure the results are clear and that participants are safe. This is why a full medical check-up is always part of joining a clinical trial.

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 chronic rhinosinusitis with nasal polyps?
Are you able to attend regular clinic visits?
Are you willing to potentially receive either Dupixent or a placebo?
Are you generally in good health other than your nasal condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in this study for at least 24 weeks, followed by a final check-up visit. Throughout this time, you would have clinic visits where the study team will carry out various assessments. These might include checking your general health, taking blood samples, and performing specific tests related to your nasal condition and breathing.

You would be given either Dupixent or a look-alike dummy medicine (placebo) to take regularly, usually as an injection. Neither you nor your study doctor would know which one you are receiving – this is called a 'double-blinded' study and helps ensure the results are fair. The study will also involve filling out questionnaires about your symptoms and how you are feeling, which are very important for understanding the impact of the treatment. The total duration of your participation would be around 6 months, plus any follow-up after the treatment period.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit if Dupixent helps improve your nasal polyps and related symptoms, potentially leading to a better quality of life. However, as some participants will receive a dummy medicine, there's no guarantee of direct benefit. Potential risks are generally related to side effects from the study medication or discomfort from tests like blood draws or nasal examinations; the study team will explain these fully. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is chronic rhinosinusitis with nasal polyps (CRSwNP)?

It's a long-term condition that causes inflammation in your nose and sinuses, often leading to growths called nasal polyps, which can block your nose and affect your sense of smell.

What is Dupixent?

Dupixent is a medicine that targets specific causes of inflammation. This study wants to see if it can help improve the lining of the nose for people with nasal polyps.

What does 'double-blinded' mean?

It means that neither you nor your study doctor will know if you are receiving the active medicine (Dupixent) or a dummy medicine (placebo). This helps make the study results more reliable.

How long will I be in the study?

You would be in the study for about 24 weeks, which is roughly 6 months, plus any follow-up visits after the treatment period.

Will I have to pay to join the study?

No, you will not have to pay to participate in the study. All study-related treatments and tests are provided as part of the research.