Study on Mepolizumab and Surgery for Patients with Chronic Rhinosinusitis with Nasal Polyps

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What is this study about?

This clinical trial is focused on studying Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP), a condition where the sinuses become inflamed and develop growths called polyps. The treatment being tested is called mepolizumab, which is a medication given as a solution for injection under the skin. The study aims to find out if combining surgical treatment with mepolizumab leads to faster control of the disease compared to using mepolizumab alone.

Participants in the study will receive either mepolizumab alone or a combination of surgery and mepolizumab. The surgery involved is called Functional Endoscopic Sinus Surgery (FESS), which is a procedure to remove nasal polyps and improve sinus drainage. The study will follow participants for 6 to 12 months to observe changes in their symptoms and overall condition.

The main focus of the study is to see how the treatment affects the severity of symptoms, including nasal polyps and sense of smell. The study will measure changes in a symptom score known as SNOT-22, which helps assess the impact of the condition on daily life. The goal is to determine the most effective way to manage CRSwNP and improve patients’ quality of life.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of chronic rhinosinusitis with nasal polyposis, and previous surgical history.

Informed consent is required to participate in the study.

2 initial treatment phase

The treatment involves the administration of mepolizumab, a medication given through a subcutaneous injection.

The dosage and frequency of mepolizumab are determined by the study protocol and are administered regularly as per the schedule.

3 surgical intervention

Some participants may undergo a surgical procedure known as Functional Endoscopic Sinus Surgery (FESS) in combination with mepolizumab treatment.

The decision for surgery is based on the study’s design to evaluate the effectiveness of combined treatment.

4 follow-up period

Participants are monitored over a period of 6 to 12 months to assess the treatment’s effectiveness.

Regular assessments include changes in symptoms such as nasal polyp score and sense of smell.

5 completion of study

The study is expected to conclude by May 31, 2026.

Final evaluations are conducted to measure the primary outcomes, including changes in symptom scores.

Who Can Join the Study?

Patients must be 18 years or older at the time they sign the consent form. There is no upper age limit.
Patients should be referred to the outpatient clinic with a doctor’s diagnosis of Chronic Rhinosinusitis (CRS). This is a condition where the sinuses are inflamed for a long time.
Patients must have a Nasal Polyps Score (NPS) of 2+2 out of a maximum score of 8. Nasal polyps are soft, painless growths inside the nose.
The severity of the condition should be measured with a SNOT22 score greater than 35. This score is a way to measure how much the condition affects the patient’s quality of life.
Patients should have Type 2 inflammation. This is a specific kind of immune response in the body.
Patients must have had at least one FESS surgery. FESS stands for Functional Endoscopic Sinus Surgery, which is a type of surgery done under general anesthesia to help with sinus problems.
Patients should not have taken systemic steroids in the last 3 months. However, a daily low dose of 5-10 mg is allowed. Systemic steroids are medications that reduce inflammation throughout the body.
Patients may have a doctor’s diagnosis of asthma. Asthma is a condition that affects the airways in the lungs, making it hard to breathe.

Who Cannot Join the Study?

Patients who are not diagnosed with Chronic Rhinosinusitis with Nasal Polyposis cannot participate. This condition involves long-term inflammation of the sinuses with growths called polyps in the nose.
Patients who are outside the specified age range cannot participate. The study is open to certain age groups, but the exact ages are not specified here.
Patients who are part of a vulnerable population cannot participate. This means people who might need extra protection or care, like those with certain disabilities or conditions, are not included.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Mepolizumab

Mepolizumab is a medication used in this trial to help manage chronic rhinosinusitis with nasal polyps (CRSwNP). It works by targeting and reducing the activity of certain immune cells that contribute to inflammation, which can help decrease the size of nasal polyps and improve symptoms.

FESS (Functional Endoscopic Sinus Surgery) is a surgical procedure used in this trial to treat patients with CRSwNP. This surgery involves using an endoscope to remove blockages in the sinuses, which can help improve airflow and drainage, reduce symptoms, and enhance the effectiveness of other treatments like mepolizumab.

Investigated diseases:

Chronic rhinosinusitis with nasal polyps

Chronic Rhinosinusitis with Nasal Polyposis – This condition is characterized by long-term inflammation of the sinuses and nasal passages, often accompanied by the growth of polyps. These polyps are non-cancerous swellings that can obstruct nasal airflow and lead to breathing difficulties. Symptoms typically include nasal congestion, reduced sense of smell, facial pain, and nasal discharge. The disease progresses with persistent inflammation, which can cause the polyps to grow larger and further block the nasal passages. Over time, this can lead to chronic discomfort and a significant impact on quality of life. The condition is often associated with other respiratory issues, such as asthma.

Trial ID:

2024-514632-24-02

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Mepolizumab and Surgery for Patients with Chronic Rhinosinusitis with Nasal Polyps

What is this study about?

Who Can Join the Study?

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