Study on Mepolizumab and Nasal Polypectomy for Patients with Chronic Rhinosinusitis

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What is this study about?

This clinical trial is focused on studying chronic rhinosinusitis (CRS), a condition where the sinuses become swollen and inflamed for a long time, often with nasal polyps, which are non-cancerous growths in the nose. The study will explore the effects of a treatment called mepolizumab, also known by its code name SB240563, which is given as an injection. Mepolizumab is a type of medication that targets specific proteins in the body to help reduce inflammation.

The purpose of the study is to see if mepolizumab can improve the quality of life for people with CRS, as measured by a questionnaire called the sinonasal outcome test (SNOT-22). Participants in the study will be divided into three groups. Some will receive mepolizumab, while others may undergo a procedure called nasal polypectomy, which is a minor surgery to remove polyps from the nose. There is also a possibility of receiving a placebo, which is a substance with no active medication. The study will monitor participants over a period of time to assess changes in their symptoms and overall well-being.

Throughout the study, various aspects will be evaluated, such as nasal symptoms, the need for additional treatments like corticosteroids, and any potential side effects of the treatment. The safety of mepolizumab will be closely monitored by collecting information on any adverse events during the study visits. The trial aims to provide valuable insights into how effective mepolizumab is in managing chronic rhinosinusitis with nasal polyps and improving patients’ lives.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of chronic rhinosinusitis with nasal polyps, and other health indicators.

Informed consent is required to participate in the study.

2 initial assessment

An initial assessment is conducted to evaluate the baseline condition. This includes a sino-nasal outcome test (SNOT-22) to measure quality of life related to nasal symptoms.

Additional assessments may include a visual analog scale (VAS) score for nasal symptoms and examination using a nasopharyngoscope.

3 treatment administration

The treatment involves the administration of mepolizumab, a medication given as a subcutaneous injection. The specific dosage is 100 mg, provided in a pre-filled syringe.

The frequency and duration of the treatment are determined by the study protocol and will be communicated during the trial.

4 ongoing monitoring

Regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes repeated SNOT-22 tests and other evaluations as needed.

The need for any additional treatments, such as rescue therapy with systemic corticosteroids or surgery, is evaluated during the study.

5 final assessment

At the end of the study period, a final assessment is conducted to evaluate the overall outcomes and any changes in symptoms or quality of life.

The results are compared to the initial assessments to determine the effectiveness of the treatment.

Who Can Join the Study?

Participant must be 18 years of age or older.
Must have a diagnosis of chronic rhinosinusitis (CRS) with nasal polyps. This means having two or more symptoms for at least 12 weeks, such as nasal blockage, nasal discharge, facial pain, or loss of smell, along with signs of nasal polyps or changes seen in a CT scan.
Must be suitable for biologic treatment as per specific guidelines. This includes having bilateral polyps and meeting three of the following criteria:
- Evidence of type 2 inflammation, which can be shown by certain blood or tissue tests.
- Need for systemic corticosteroids (a type of medication) or having a reason not to use them.
- Significantly impaired quality of life.
- Significant loss of smell.
- Diagnosis of comorbid asthma (having asthma along with CRS).
For patients who have not had surgery and are not fit for it, or those who have had surgery and the condition has returned, a basal eosinophil count of 300 cells/µL or more is required. Eosinophils are a type of white blood cell.
Patients must be informed about the study and must sign a consent form to participate.
For patients not suitable for surgery, specific criteria for biological treatment will be used, including a basal eosinophil count of 300 cells/µL or more.

Who Cannot Join the Study?

Patients who have a different condition than chronic rhinosinusitis (CRS) cannot participate. CRS is a long-term inflammation of the sinuses and nasal passages.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection, like children or the elderly.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Hospital Universitario De Cruces	Barakaldo	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hnobljck Uoofcoyruwcak Mgmdsfn Dv Vtjqoqjwvb	Santander	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Mepolizumab

Mepolizumab is a medication used in this trial to help reduce inflammation in patients with chronic rhinosinusitis. It works by targeting specific proteins in the body that contribute to inflammation, which can help decrease the size of nasal polyps and improve breathing and overall quality of life.

In-office nasal polypectomy is a procedure performed in a medical office setting to remove nasal polyps. This therapy is used to physically eliminate the polyps that can block nasal passages, helping to improve airflow and reduce symptoms associated with chronic rhinosinusitis.

Investigated diseases:

Chronic rhinosinusitis with nasal polyps

Chronic Rhinosinusitis – Chronic rhinosinusitis is a long-lasting inflammation of the nasal passages and sinuses. It is characterized by nasal congestion, facial pain or pressure, and a reduced sense of smell. The condition can lead to the formation of nasal polyps, which are non-cancerous growths in the nasal passages or sinuses. Symptoms often persist for more than 12 weeks despite treatment attempts. The inflammation can be caused by infections, allergies, or other factors that irritate the nasal passages. Over time, chronic rhinosinusitis can significantly impact a person’s quality of life due to persistent discomfort and breathing difficulties.

Trial ID:

2023-505426-34-01

Protocol code:

MELYSA

NCT ID:

NCT05923047

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Mepolizumab and Nasal Polypectomy for Patients with Chronic Rhinosinusitis

What is this study about?

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