Recruiting

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

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

8 criteria

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 trial?

3 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Rigshospitalet
Copenhagen, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

Mepolizumab

What is already known about the treatment

Mepolizumab – Mepolizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating chronic rhinosinusitis with nasal polyposis, often in combination with surgical procedures. The medication works by targeting and inhibiting interleukin-5, a protein that plays a key role in the inflammation process associated with this condition. Mepolizumab is classified as a monoclonal antibody and is primarily used to reduce inflammation and improve symptoms in patients with certain inflammatory conditions.

Investigated diseases

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.