RecruitingNAINTERVENTIONAL

BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry

This French study is examining new biologic medications for severe nasal polyps. Nasal polyps are growths in the nose and sinuses that can greatly affect a person's quality of life. While surgery is often a treatment, these new medicines offer another option for some. Researchers are collecting information from patients who are already receiving these biologic treatments. They want to understand how effective the treatments are at improving patients' quality of life, what factors doctors consider when deciding if these medicines are suitable, and if patients experience any side effects. The goal is to learn more about how these modern treatments are working in real-world settings.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Lille

Enrolment target

900

Start

11 Jul 2024

Estimated completion

02 Jan 2035

Rhinosinusitis Chronic Nasal Polyps

What is this study about?

This study is happening in France and is looking at how well new types of medicine, called biologics, work for people with severe nasal polyps. Nasal polyps are non-cancerous growths that can appear in your nose and sinuses, making it hard to breathe, causing you to lose your sense of smell, and generally affecting your daily life. They can be a real nuisance for many people.

Doctors have found that severe nasal polyps are often linked to a particular overreaction of the body's immune system. The new biologic medicines are designed to calm this immune overreaction. Currently, if standard treatments like steroid nasal sprays don't work, surgery is often suggested. However, these new biologic medicines offer another option for some patients, and this study aims to see how they perform in practice.

Researchers aren't testing a new drug; instead, they are collecting information from patients who are already being treated with these approved biologic medicines for their nasal polyps. They want to see if the treatments improve patients' quality of life, what clinical signs or lab test results doctors use to decide who should get these medicines, and whether patients experience any side effects. They will also look at how different health conditions, like allergies or asthma, might affect a patient's response to treatment.

Key takeaways

This study in France is collecting information on biologic treatments for severe nasal polyps.
It aims to understand how these medicines affect patients' quality of life.
Researchers are observing patients who are already receiving approved biologic treatments.
The study also looks at reasons doctors prescribe these treatments and potential side effects.
It's an 'observational' study, meaning no new experimental treatments are given.

Who may be eligible?

To be part of this study, you must be an adult, aged 18 or older, who needs or is already receiving a specific biologic treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in line with its official approval. This means your doctor would have decided this treatment is right for you based on current guidelines.

However, you wouldn't be able to join if you've recently taken certain steroid medicines by mouth (within the last month), or if you've recently had other specific biologic treatments for inflammatory conditions (in the past 6 months), unless it was for your severe asthma or CRSwNP and you are still on it. You also couldn't take part if you have an allergy to medicines made from human antibodies.

Pregnant or breastfeeding women, people who have had a COVID-19 infection with persistent smell problems in the last three months, or those without social health insurance cover for medical care, would also not be able to participate.

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?
Are you currently receiving, or are you about to start, an approved biologic treatment for severe nasal polyps?
Have you avoided steroid tablets or liquid in the last month?
Are you not pregnant or breastfeeding?
Have you not had a recent COVID-19 infection with lasting smell problems (in the last 3 months)?

Answer every question to see your result.

What does participation involve?

This study is an 'observational' study. This means you wouldn't be given a new or experimental treatment. Instead, researchers would collect information from your existing medical records if you are already receiving one of the approved biologic treatments for your severe nasal polyps. If you start a biologic treatment during the study, they would also follow your progress.

The researchers will look at how your quality of life changes, how your symptoms are, and what test results you have. They will also note any side effects you experience. There are no extra visits or assessments specifically for this study beyond your regular doctor appointments for your treatment. The total duration of your participation would depend on how long you receive the treatment and how long the researchers choose to follow up on your progress.

Potential risks and benefits

Since this is an observational study and you would be receiving an approved medicine that your doctor has prescribed, there are generally no additional risks specific to the study beyond those already associated with your ongoing medical treatment. The potential benefits include contributing to a better understanding of how these new biologic medicines work for people with nasal polyps, which could help future patients. You have the right to withdraw your consent for your medical information to be used in the study at any time without affecting your medical care.

Locations (2)

CHU de Lille
Verified postcode
Lille, France· Active not recruiting
chu de Lille
Verified postcode
Lille, France· Recruiting

Common questions

What are nasal polyps?

Nasal polyps are soft, painless, non-cancerous growths inside your nose or sinuses, often linked to ongoing inflammation.

What is a 'biologic' treatment?

Biologic treatments are medicines made from natural sources like human or animal cells, designed to target specific parts of the immune system.

Will I get a new drug if I join?

No, this study only looks at people who are already receiving biologic treatments that are approved and prescribed by their doctor.

What does 'observational study' mean?

An observational study means researchers collect information as part of your normal care; you don't receive experimental treatments or have extra procedures for the study.

Will this study affect my usual medical care?

No, your medical care and treatment decisions will continue to be made by your doctor as normal, independent of your participation in this study.

How to find out more

Geoffrey Mortuaire, MD, pHD

geoffrey.mortuaire@chru-lille.fr 0320445675 Official trial record

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