Ongoing Clinical Trials for Chronic Rhinosinusitis Without Nasal Polyps
There are currently 3 ongoing clinical trials investigating new treatments for chronic rhinosinusitis without nasal polyps. These studies are testing medications that aim to reduce sinus inflammation and improve nasal symptoms. Trials are being conducted across multiple countries in Europe, with treatments including dupilumab, itepekimab, and brensocatib.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- Denmark
- France
- Germany
- Hungary
- Italy
- Poland
- Portugal
- Romania
- Spain
Study on the Effect of Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps
This trial is investigating how dupilumab affects the nasal lining in patients with chronic rhinosinusitis, including those without nasal polyps. The study is being conducted in Austria and will last for six months.
Who can participate: Adults aged 18 to 99 years with a confirmed diagnosis of chronic rhinosinusitis according to specific medical criteria can join this study. The trial includes two groups: one for patients without nasal polyps and another for those with polyps. Participants who previously received monoclonal antibody treatments must have stopped these medications at least six months before enrolling. Patients may have a condition called NSAID-Exacerbated Respiratory Disease, which involves reactions to certain pain relievers.
Who cannot participate: Patients currently receiving monoclonal antibody therapy are excluded from this study. Those who do not have chronic rhinosinusitis or fall outside the specified age range cannot participate. Pregnant or breastfeeding women are also excluded, as are individuals with other medical conditions that might make participation unsafe. Patients participating in another clinical trial at the same time are not eligible.
What the study focuses on: The main goal is to understand how dupilumab impacts nasal barrier function, which is the protective ability of the nasal lining. Researchers will monitor changes in nasal cell barrier sensitivity, protein expression levels, and cytokine levels throughout the study period. Regular visits at baseline, 3 months, and 6 months will track these changes.
Investigational medication: Dupilumab (Dupixent 300 mg) is administered as an injection under the skin. It is a monoclonal antibody that works by blocking two proteins called interleukin-4 and interleukin-13, which are involved in inflammatory responses. The medication aims to reduce inflammation and improve symptoms in patients with this condition.
Study on the Effects of Itepekimab for Patients with Chronic Rhinosinusitis Without Nasal Polyps
This international trial is testing itepekimab, a monoclonal antibody, for treating chronic rhinosinusitis without nasal polyps. The study is taking place across seven European countries including Poland, Romania, Portugal, Belgium, Spain, France, and Italy, and will run for up to 24 weeks.
Who can participate: Adults aged 18 years or older who have experienced symptoms of nasal congestion or blockage for at least 12 consecutive weeks can apply. Participants must have a Nasal Congestion Score of 2 or higher and a sinus Total Symptom Score of 5 or more. Eligible patients must have either undergone previous sinus surgery, received systemic corticosteroid treatment in the past two years, or experienced worsening symptoms requiring such treatment. CT scans must show at least 25% blockage in specific sinus areas. Participants need to have a SNOT-22 score of 20 or more and have been using mometasone furoate nasal spray consistently for at least three weeks. Women of childbearing potential must agree to use highly effective contraception during the study and for 20 weeks after the last dose.
Who cannot participate: Patients with certain respiratory tract diseases are excluded. Only individuals within the specified age range can participate. Those who belong to vulnerable populations, such as children or pregnant women, are not eligible. Patients outside the specific clinical trial groups cannot join.
What the study focuses on: The primary aim is to evaluate whether itepekimab can effectively reduce sinus blockage compared to placebo. Throughout the 24-week period, participants will track their symptoms daily using an electronic diary, recording nasal congestion, runny nose, facial pain, and loss of smell. Regular CT scans will monitor changes in sinus opacification. The study will also assess the safety and tolerability of itepekimab, watching for any side effects.
Investigational medication: Itepekimab is a monoclonal antibody administered through injection under the skin using a pre-filled syringe. It works by targeting and blocking a protein called interleukin-33, which plays a role in the inflammation process. This medication is being studied specifically for its ability to reduce sinus inflammation in patients without nasal polyps.
Study on the Effectiveness and Safety of Brensocatib for Patients with Chronic Rhinosinusitis Without Nasal Polyps
This large-scale European study is examining brensocatib, an oral medication, for treating chronic rhinosinusitis without nasal polyps. The trial is being conducted in 11 countries including Italy, Germany, Poland, Czechia, Bulgaria, Portugal, Denmark, Belgium, Spain, France, and Hungary, and will last for 24 weeks.
Who can participate: Men and women between 18 and 75 years old who have had chronic rhinosinusitis without nasal polyps for at least 12 weeks can participate. Eligible patients must currently have nasal congestion symptoms and a blood eosinophil count of 750 cells/µL or less. Participants must have received previous treatment for this condition, including either sinonasal surgery, systemic corticosteroids, or antibiotics within the year before screening. They must also have been taking a stable daily dose of mometasone furoate nasal spray for at least four weeks before randomization.
Who cannot participate: Patients with other significant health conditions that might interfere with the study are excluded. Those currently participating in another clinical trial or who have had recent surgery or are planning surgery during the study period cannot join. Pregnant or breastfeeding women are not eligible. Individuals with known allergies to the study medication or its ingredients, a history of drug or alcohol abuse, or severe allergic reactions are excluded. Patients unable to comply with study procedures or with a history of non-compliance with medical treatments cannot participate. Those requiring medications that might interfere with the study drug are also excluded.
What the study focuses on: The study aims to determine whether brensocatib, taken as a daily tablet at doses of 10 mg or 40 mg, can improve nasal symptoms compared to placebo. The trial is conducted in a double-blind manner, meaning neither participants nor researchers know who receives the actual medication or placebo. Throughout the 24 weeks, regular assessments will measure changes in nasal symptoms using the Sinus Total Symptom Score and Nasal Congestion Scores. The study will monitor adverse events, clinical laboratory test results, vital signs, and heart function. Participants will keep daily records of their nasal symptoms.
Investigational medication: Brensocatib is taken orally as a film-coated tablet once daily. It works by inhibiting certain enzymes that contribute to inflammation, thereby potentially reducing symptoms like nasal congestion and discomfort. This anti-inflammatory agent is currently being studied to establish its safety and effectiveness for treating chronic rhinosinusitis without nasal polyps.
Summary
Three clinical trials are currently investigating different treatment approaches for chronic rhinosinusitis without nasal polyps across Europe. The studies are testing three distinct medications: dupilumab (a subcutaneous injection), itepekimab (also an injection), and brensocatib (an oral tablet). All three drugs work by targeting different aspects of the inflammatory process that drives this condition.
The brensocatib trial has the widest geographic reach, operating in 11 European countries, while the itepekimab study covers 7 countries. The dupilumab trial is currently limited to Austria. All studies require participants to have documented chronic rhinosinusitis and to be using nasal spray medication as background therapy. The trials vary in duration from 24 weeks to 6 months and focus on measuring improvements in nasal symptoms, sinus blockage, and quality of life while monitoring safety.
These studies represent important research efforts to find new treatment options for patients whose symptoms are not adequately controlled with standard therapies. Each medication uses a different mechanism to reduce inflammation, offering potential alternatives for patients who may not respond to one particular approach.
