Study on How Mepolizumab Affects Patients with Chronic Rhinosinusitis with Nasal Polyps

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What is this study about?

This clinical trial is focused on studying a condition known as Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). This is a long-term condition where the sinuses become inflamed and develop growths called polyps. The study will also look at a related condition called Chronic Rhinosinusitis without Nasal Polyps (CRSsNP). The treatment being tested in this study is a medication called Mepolizumab, which is given as a solution for injection using a pre-filled pen. Mepolizumab is designed to help reduce inflammation and improve symptoms in patients with these conditions.

The purpose of the study is to identify specific markers in the body, known as biomarkers, that can predict how well a patient with CRSwNP will respond to treatment with Mepolizumab. The study will also explore how cells from patients react to Mepolizumab in a laboratory setting, which may help understand the immune responses involved in these conditions. Participants in the study will receive either Mepolizumab or a placebo, and their responses will be monitored over a period of six months.

Throughout the study, researchers will collect information on how the treatment affects symptoms and the immune system. This includes looking at changes in nasal symptoms and examining how cells and molecules in the body respond to the treatment. The study aims to provide insights that could lead to better treatment strategies for people with CRSwNP and CRSsNP in the future.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to identify biomarkers that predict how patients with chronic rhinosinusitis with nasal polyps (CRSwNP) respond to the medication mepolizumab.

You will be part of a group of adult patients who meet specific criteria, such as being 18 years or older and having a diagnosis of CRSwNP.

2 initial assessment

An initial assessment will be conducted to evaluate your current health status and symptoms. This may include a nasal endoscopy to ensure there are no abnormalities.

Your symptoms will be recorded, focusing on nasal congestion, blockage, or obstruction, with moderate or severe symptom scores.

3 medication administration

You will receive the medication Nucala 100 mg, which contains the active substance mepolizumab. This medication is administered as a solution for injection using a pre-filled pen.

The injection is given subcutaneously, meaning it is injected under the skin. The frequency and duration of administration will be explained to you by the study team.

4 monitoring and follow-up

Throughout the study, your response to the medication will be monitored. This includes regular check-ups to assess any changes in your symptoms and overall health.

The study aims to identify changes in specific biomarkers and immune responses, which will be measured through various tests and assessments.

5 completion of the study

The study is expected to continue until July 2025. Upon completion, a final assessment will be conducted to evaluate the overall effectiveness of the treatment and any changes in your condition.

Your participation will contribute to a better understanding of how mepolizumab works in treating CRSwNP and may help improve future treatments for this condition.

Who Can Join the Study?

Must be an adult (18 years or older).
For the group with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Must have CRSwNP and meet the criteria for treatment with a biological medication called mepolizumab.
For the group with Chronic Rhinosinusitis without Nasal Polyps (CRSsNP): Must have a diagnosis of CRSsNP by an ENT (Ear, Nose, and Throat) doctor and have ongoing symptoms for at least 8 weeks before joining the study. Symptoms include nasal congestion, blockage, or obstruction with moderate or severe scores.
For the healthy control group: Must be in good general health and have no abnormalities found during a nasal endoscopy (a procedure where a doctor looks inside the nose with a special camera).
Both men and women can participate.
Participants should not be part of a vulnerable population.

Who Cannot Join the Study?

Patients who do not have chronic rhinosinusitis with nasal polyps (CRSwNP) cannot participate. This is a condition where the spaces inside your nose and head (sinuses) are swollen for a long time, and you have growths called polyps in your nose.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are important to ensure the safety and effectiveness of the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Asdixlmfi Usm	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Mepolizumab

Mepolizumab is a medication used in this clinical trial to help people with a condition called chronic rhinosinusitis with nasal polyps (CRSwNP). This condition causes long-term inflammation in the nose and sinuses, leading to the growth of polyps, which are small, non-cancerous swellings. Mepolizumab works by targeting a specific protein in the body that plays a role in inflammation. By reducing this inflammation, mepolizumab can help decrease the size of the polyps and improve symptoms like nasal congestion and loss of smell. The trial aims to find out how well mepolizumab works for different patients and to understand the immune system’s response to this treatment.

Investigated diseases:

Chronic rhinosinusitis with nasal polyps

Chronic rhinosinusitis with nasal polyps (CRSwNP) – This condition is characterized by inflammation of the nasal passages and sinuses lasting for at least 12 weeks, accompanied by the growth of polyps in the nasal cavity. These polyps are non-cancerous, soft, and painless, but they can obstruct nasal passages, leading to breathing difficulties. The inflammation is often due to an ongoing immune response, which can cause symptoms like nasal congestion, loss of smell, and facial pressure. The disease progresses with persistent inflammation, which can lead to recurring symptoms and potential complications if not managed. The presence of nasal polyps distinguishes this condition from other forms of chronic rhinosinusitis.

Trial ID:

2023-508069-34-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on How Mepolizumab Affects Patients with Chronic Rhinosinusitis with Nasal Polyps

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?