Study on Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Dupilumab on patients who have two specific conditions: chronic rhinosinusitis with nasal polyps and eosinophilic otitis media. Chronic rhinosinusitis with nasal polyps is a long-term inflammation of the sinuses that leads to the growth of polyps, which are small, non-cancerous swellings. Eosinophilic otitis media is a type of ear inflammation characterized by the presence of a high number of eosinophils, which are a type of white blood cell. The medication being tested, Dupilumab, is administered as a solution for injection using a pre-filled pen.

The purpose of this study is to understand how Dupilumab affects ear symptoms and hearing function in patients with these conditions. Participants in the study will receive Dupilumab through subcutaneous injection, which means the medication is injected under the skin. The study will observe changes in symptoms and hearing over a period of time, specifically looking at how these change from the start of the treatment to 6 or 12 months later. Participants will be asked to complete questionnaires about their symptoms and undergo hearing tests to track any improvements or changes.

Throughout the study, researchers will monitor the participants’ progress by comparing their initial condition with their condition after receiving Dupilumab for several months. This will help determine the effectiveness of the treatment in managing symptoms related to chronic rhinosinusitis with nasal polyps and eosinophilic otitis media. The study aims to provide valuable insights into how Dupilumab can potentially improve the quality of life for individuals suffering from these conditions.

1 initiation of treatment

Begin treatment with Dupixent, which contains the active substance dupilumab.

The medication is administered as a subcutaneous injection using a pre-filled pen.

The dosage is 300 mg per injection.

2 baseline assessment

Complete initial assessments, including otologic questionnaires to evaluate ear symptoms and auditory function.

These assessments establish a baseline for future comparisons.

3 ongoing treatment and assessments

Continue receiving Dupixent injections as part of regular clinical care.

Assessments will be conducted at 1, 3, 6, and 12 months to monitor changes in questionnaire scores, audiometry outcomes, and otoscopic findings.

The primary focus is on changes between baseline and 6 or 12 months of treatment.

4 completion of study

The study is expected to conclude by October 2, 2027.

Final assessments will be compared to baseline data to determine the effect of dupilumab on ear symptoms and auditory function.

Who Can Join the Study?

Patients must have chronic rhinosinusitis with nasal polyps and eosinophilic otitis media. These are conditions that affect the nose and ears.
For the retrospective part of the study, patients should have started dupilumab treatment from 2020 onwards. Dupilumab is a medication used to treat certain conditions.
Patients must have enough data available to meet the main goal of the study, which includes completing specific ear-related questionnaires at the start and after at least 6 or 12 months of treatment.
For the prospective part of the study, patients must be adults, meaning they are 18 years or older, and are starting dupilumab treatment as part of their regular medical care.
Both men and women can participate in the study.
The study does not include vulnerable populations, which means it does not involve groups that might need special protection.

Who Cannot Join the Study?

Patients who do not have chronic rhinosinusitis with nasal polyps or eosinophilic otitis media cannot participate. These are specific conditions related to inflammation in the nose and ears.
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.

Where you can join this trial?

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Site Name	City	Country	Status
Aszixipce Uln	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.07.2024

Trial locations

Investigated drugs:

Dupilumab

Dupilumab is a medication used in this clinical trial to treat patients with chronic rhinosinusitis with nasal polyps and eosinophilic otitis media. It works by blocking certain proteins in the body that can cause inflammation, helping to reduce symptoms such as nasal congestion and improve ear function.

Investigated diseases:

Chronic Rhinosinusitis with Nasal Polyps – This condition involves 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 may include nasal congestion, reduced sense of smell, and facial pressure or pain. The condition can persist for months or even years, with symptoms fluctuating in severity. It is often associated with other respiratory conditions, such as asthma. The exact cause is not fully understood, but it may involve a combination of genetic and environmental factors.

Eosinophilic Otitis Media – This is a type of ear inflammation characterized by the presence of a high number of eosinophils, a type of white blood cell, in the middle ear. It often occurs in individuals with asthma or nasal polyps and can lead to persistent ear infections. Symptoms may include ear pain, hearing loss, and a feeling of fullness in the ear. The condition can be chronic, with symptoms that may worsen over time. It is thought to be related to an underlying allergic or immune response. The exact mechanisms and triggers are still being studied.

Trial ID:

2023-508068-31-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?