Study Comparing Dupilumab and Mepolizumab for Treating Chronic Rhinosinusitis with Nasal Polyps in Danish Patients

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What is this study about?

This clinical trial is focused on studying the treatment of chronic rhinosinusitis with nasal polyposis, a condition where the sinuses become inflamed and develop growths called polyps. The study aims to compare two medications: dupilumab and mepolizumab. Dupilumab, also known by its code names REGN668 and SAR231893, is administered as a solution for injection. Mepolizumab, sometimes referred to by its code name SB240563, is also given as an injection. Both medications are designed to help reduce inflammation and improve symptoms in patients with this condition.

The purpose of the study is to determine how effective each medication is in treating the symptoms of chronic rhinosinusitis with nasal polyposis. Participants in the study will receive either dupilumab or mepolizumab and will be monitored over a period of time to assess changes in their symptoms. The study will look at both objective measures, such as the size of the nasal polyps, and subjective measures, like the patient’s sense of smell and overall quality of life.

Throughout the study, participants will be asked to attend regular check-ups to track their progress. The study will last for a specified period, during which the effectiveness of the treatments will be evaluated. The goal is to see if one medication is superior to the other or if they are equally effective in managing the symptoms of chronic rhinosinusitis with nasal polyposis.

1 initial assessment

Upon joining the clinical trial, an initial assessment will be conducted to confirm eligibility. This includes verifying the presence of chronic rhinosinusitis with nasal polyposis and other criteria such as age and medical history.

2 baseline measurements

Baseline measurements will be taken to assess the current state of your condition. This includes a nasal polyp score (NPS) and a Sino-nasal outcome test 22 (SNOT-22) score.

3 treatment allocation

You will be randomly assigned to receive either dupilumab or mepolizumab. Both are administered as a subcutaneous injection.

4 medication administration

If assigned to dupilumab, you will receive a 300 mg injection every two weeks. If assigned to mepolizumab, you will receive a 100 mg injection every four weeks.

5 ongoing assessments

Throughout the trial, regular assessments will be conducted to monitor changes in your condition. This includes repeating the NPS and SNOT-22 scores at 24 weeks and 52 weeks.

6 additional evaluations

Additional evaluations may include tests for sense of smell, asthma symptoms, and quality of life assessments. These help to understand the broader impact of the treatment.

7 completion of trial

The trial is expected to conclude by February 2025. At the end of the trial, a final assessment will be conducted to evaluate the overall effectiveness of the treatment.

Who Can Join the Study?

Have chronic rhinosinusitis with bilateral nasal polyposis (this means long-term inflammation of the sinuses with growths on both sides of the nose).
Be over 18 years old.
Be able to read and/or speak Danish.
Show evidence of type 2 inflammation, which can be measured by high levels of a type of white blood cell called eosinophils in the blood or tissue, or have late-onset eosinophilic asthma.
Have had at least one endoscopic sinus surgery in the past seven years, or be unable to have sinus surgery.
Have been using nasal steroid spray and nasal rinses twice a day for at least three months before starting treatment.
Meet at least three of the following five conditions:
- Need for systemic corticosteroids (a type of medication) at least twice a year, or one long-term treatment lasting more than three months, or have reasons why you cannot take these medications.
- A score of at least 50 on the Sino-nasal outcome test 22 (SNOT-22), which measures the impact of sinus problems on your life.
- Reduced sense of smell, defined as a score of 0-8 on the Sniffin Sticks-Evaluation Identification Test 16 (UPSIT-16).
- A nasal polyp score (NPS) of at least 2 on both sides, and a total score of at least 5.
- Have asthma that requires the use of inhaled corticosteroids.

Who Cannot Join the Study?

Patients who do not have chronic rhinosinusitis with nasal polyposis cannot participate. This is a condition where the sinuses are inflamed for a long time, and there are growths called polyps in the nose.
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 be at higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Odense University Hospital	Odense	Denmark
Zealand University Hospital	Koege	Denmark
Nordsjaellands Hospital	Hillerød	Denmark
Rqpydp Mtbaurzdyiu	Herning	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	21.03.2023

Trial locations

Investigated drugs:

Dupilumab is a medication used in this clinical trial to treat rhinosinusitis with nasal polyps. It works by blocking certain proteins in the body that can cause inflammation. This helps reduce the size of the nasal polyps and improve symptoms like nasal congestion and loss of smell. Patients in the trial will receive dupilumab to see how well it works compared to another treatment.

Mepolizumab is another medication being tested in the trial for treating rhinosinusitis with nasal polyps. It helps by targeting and reducing the activity of specific cells in the immune system that contribute to inflammation and the growth of nasal polyps. The trial aims to compare the effectiveness of mepolizumab with dupilumab to see which one provides better relief from symptoms.

Investigated diseases:

Chronic rhinosinusitis with nasal polyps

Chronic rhinosinusitis with nasal polyposis – 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. The disease typically causes symptoms such as nasal congestion, facial pain, and a reduced sense of smell. Over time, the persistent inflammation can lead to further complications, including sinus infections. The presence of nasal polyps can also exacerbate other respiratory conditions, such as asthma. The progression of the disease can vary, with some individuals experiencing more severe symptoms than others.

Trial ID:

2022-502250-14-00

Protocol code:

TORNADO

NCT ID:

NCT05942222

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Dupilumab and Mepolizumab for Treating Chronic Rhinosinusitis with Nasal Polyps in Danish Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?