Study on the Effect of Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Dupilumab on a condition known as Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Chronic rhinosinusitis is a long-term inflammation of the sinuses, and it can occur with or without nasal polyps, which are non-cancerous growths in the nasal passages. The study will explore how Dupilumab, which is administered as a solution for injection, affects the nasal lining in patients with CRSwNP.

The purpose of the study is to understand how Dupilumab impacts the nasal barrier function, which is the ability of the nasal lining to protect against harmful substances. Participants will receive Dupilumab treatment over a period of six months. The study will involve regular visits to monitor changes in the nasal barrier and other related factors. Some participants will receive a placebo for comparison.

Throughout the study, researchers will collect samples and data to assess changes in the nasal lining and other biological markers. This will help determine the effectiveness of Dupilumab in improving the condition of patients with CRSwNP. The study aims to provide valuable insights into the treatment of chronic rhinosinusitis and the role of Dupilumab in managing this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of chronic rhinosinusitis with or without nasal polyps.

Eligibility criteria include being between 18 and 99 years of age and having a diagnosis of chronic rhinosinusitis as per EPOS 2020 criteria.

2 baseline visit

During the baseline visit, the primary endpoint is measured. This involves assessing the barrier sensitivity of nasal cells in both stimulated and unstimulated conditions.

This visit establishes the initial condition of the nasal epithelium before any treatment is administered.

3 treatment initiation

The treatment involves the administration of dupilumab, a medication given as a subcutaneous injection.

The specific product used is Dupixent 300 mg, available in a pre-filled syringe or pen.

4 follow-up visits

Follow-up visits occur at 3 months and 6 months after the start of treatment.

During these visits, changes in the barrier sensitivity of nasal cells are monitored, along with other secondary endpoints such as protein expression levels and cytokine levels.

5 final assessment

At the end of the 6-month treatment period, a final assessment is conducted to evaluate the overall effect of dupilumab on nasal epithelial barrier function.

This includes a comparison of data collected at baseline and throughout the study period.

Who Can Join the Study?

Must be between 18 and 99 years old.
Must be willing to participate in the study.
Must have chronic rhinosinusitis, which is a long-term inflammation of the sinuses, as defined by specific criteria.
For Group 1 (20 participants with CRSsNP): Must not have nasal polyps, which are non-cancerous growths in the nasal passage.
For Group 2 (60 participants with CRSwNP): Must have nasal polyps confirmed by a camera examination (endoscopy) or a CT scan and plan to receive treatment with a medication called dupilumab.
Can have or not have a condition called NSAID-Exacerbated Respiratory Disease (N-ERD), which is a reaction to certain pain relievers that affects breathing.
If previously treated with monoclonal antibodies for asthma or polyps, must have stopped the treatment for at least 6 months before joining the study. Monoclonal antibodies are special proteins used to treat some diseases.

Who Cannot Join the Study?

Patients who are currently receiving therapy with monoclonal antibodies. These are special medications made from proteins that can attach to specific targets in the body, often used to treat certain diseases.
Patients who do not have chronic rhinosinusitis. This is a long-term condition where the spaces inside the nose and head (sinuses) become swollen and inflamed.
Patients who are not within the specified age range for the study.
Patients who are not able to provide informed consent or do not have a legal representative to do so on their behalf.
Patients who are pregnant or breastfeeding.
Patients with other medical conditions that the study doctors believe would make it unsafe for them to participate.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Dupilumab

Dupilumab is a medication used in this clinical trial to study its effect on the nasal epithelial barrier function in patients with Chronic Rhinosinusitis with nasal polyps (CRSwNP). It is a type of monoclonal antibody that helps reduce inflammation and improve symptoms in patients with this condition. The trial aims to understand how this medication can improve the barrier function of the nasal lining in affected individuals.

Investigated diseases:

Chronic Rhinosinusitis with Nasal Polyps – This condition involves long-term inflammation of the sinuses and nasal passages, accompanied by the growth of polyps. These polyps are non-cancerous swellings that can obstruct nasal airflow and lead to breathing difficulties. Patients often experience symptoms such as nasal congestion, loss of smell, and facial pressure. The disease progresses with persistent inflammation, which can cause the polyps to increase in size and number. Over time, this can lead to more severe nasal blockage and a greater impact on quality of life. The condition is often associated with other respiratory issues, such as asthma.

Chronic Rhinosinusitis without Nasal Polyps – This disease is characterized by prolonged inflammation of the sinuses and nasal passages, but without the presence of polyps. Symptoms typically include nasal congestion, facial pain, and a reduced sense of smell. The inflammation can lead to thickened sinus linings and mucus buildup, causing discomfort and difficulty breathing. As the condition progresses, it may result in more frequent sinus infections and increased nasal obstruction. The absence of polyps distinguishes it from other forms of chronic rhinosinusitis, but it still significantly affects daily activities and overall well-being.

Trial ID:

2023-509815-10-00

Protocol code:

EpiBar

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?