Mepolizumab for Chronic Rhinosinusitis with Nasal Polyps
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Mepolizumab, a drug targeting a protein involved in inflammation, to assess its effects on individuals with chronic rhinosinusitis with nasal polyps (CRSwNP), a condition characterized by swollen and inflamed spaces inside the nose and head. Researchers aim to understand how blocking this protein might alter immune responses in the nose. The trial includes three groups: those with CRSwNP and asthma who will receive Mepolizumab, those with chronic rhinosinusitis without nasal polyps who will continue their usual care, and healthy individuals for comparison. Individuals with both CRSwNP and asthma who are awaiting surgery might be suitable for the treatment group. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on certain treatments for infections or have received monoclonal antibody therapy, you may not be eligible. It's best to discuss your specific medications with the trial team.
What is the safety track record for Mepolizumab?
Research has shown that mepolizumab is generally safe for people with chronic rhinosinusitis with nasal polyps (CRSwNP). Approved since 2021, this treatment's safety is supported by previous studies. Some individuals might experience side effects, but these are usually mild. Mepolizumab should not be used by those allergic to it or any of its ingredients. Although serious side effects can occur, they are rare. Overall, available data consider the treatment safe.12345
Why are researchers enthusiastic about this study treatment?
Mepolizumab is unique because it targets interleukin-5 (IL-5), a protein that plays a key role in the inflammation process, specifically reducing eosinophils, which are often elevated in conditions like chronic rhinosinusitis with nasal polyps (CRSwNP). Unlike standard treatments such as corticosteroids or surgery, which mainly address symptoms or physical blockages, mepolizumab works at the immune level to tackle the underlying cause of inflammation. This targeted approach not only offers a new avenue for managing CRSwNP but also holds promise for patients who have not found relief with traditional therapies. Researchers are excited because it could lead to better symptom control and potentially fewer side effects.
What is the effectiveness track record for Mepolizumab in treating chronic rhinosinusitis with nasal polyps?
Research has shown that mepolizumab effectively treats chronic rhinosinusitis with nasal polyps (CRSwNP). Studies have found that it significantly reduces nasal symptoms and the size of nasal polyps. In this trial, participants with CRSwNP and asthma will receive mepolizumab treatment. Specifically, patients in those studies experienced a better quality of life and needed fewer nasal surgeries. Importantly, their sense of smell improved, with noticeable gains at 6 and 12 months. These benefits make mepolizumab a promising option for managing CRSwNP.15678
Are You a Good Fit for This Trial?
Adults diagnosed with chronic rhinosinusitis and nasal polyps, who have asthma symptoms and reversible airflow obstruction. They must be on a surgery waitlist for over 6 months, without other sinonasal diseases or severe allergies to monoclonal antibodies. Pregnant women, those with certain infections or immune conditions, severe heart failure, recent major organ transplants, or participation in other trials are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Nasal and blood samples collected before Mepolizumab commencement
Treatment
Participants receive 100mg of Mepolizumab every 4 weeks subcutaneously
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mepolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Paul's Sinus Centre
Lead Sponsor