Analyzing immune profiles in patients with chronic rhinosinusitis after mepolizumab treatment
Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment
This study is testing how well a medication called mepolizumab works for people with chronic sinus problems and asthma by looking at their immune responses before and after treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | St. Paul's Sinus Centre Academic / other |
| Drugs / interventions | Mepolizumab |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05642806 on ClinicalTrials.gov |
What this trial studies
This study investigates the immune profiles of patients suffering from Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and asthma, as well as those with Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) and asthma, before and after treatment with mepolizumab. It is a 24-week randomized, double-blind, placebo-controlled trial where participants will undergo various assessments, including nasoendoscopy and blood tests, to evaluate their immune responses. The study aims to compare the molecular profiles of these patient groups to better understand the effects of mepolizumab on their conditions.
Who should consider this trial
Good fit: Ideal candidates include adults over 19 with chronic rhinosinusitis with or without asthma.
Not a fit: Patients with current or past sinonasal or bronchial tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with chronic rhinosinusitis and asthma.
How similar studies have performed: Other studies have shown promising results with mepolizumab in treating similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Are over the age of 19. 2. Patients with CRSwNP with or without asthma: * Asthma confirmed with a spirometry and assessment on previous history of asthma (a methacholine challenge test and atopy testing to document positive or negative history of asthma will be performed if there is no clinical record). * Presence or absence of nasal polyps. This can be based on formal exam at Baseline Visit or historical assessment. 3. Patients with CRSsNP with asthma: * These patients will not take the study treatment and they will only complete screening and baseline visits. 4. Females of childbearing potential must commit to using an acceptable method of birth control for the duration of the study and they must have a negative urine pregnancy test at each study visit. Exclusion Criteria: 1. Current or past sinonasal or bronchial tumours 2. Subjects who have been treated with oral antibiotics in the past month prior to surgery. 3. Subjects with known immunodeficiency 4. Subjects with known autoimmune disease 5. Smoking history; current or former smokers. 6. Prior lung transplants 7. Subjects with parasitic (helmintic) infection 8. Subjects with hypersensitivity; with allergy/intolerance to a monoclonal antibody or biologic 9. Female participants who are pregnant or breastfeeding
Where this trial is running
Vancouver, British Columbia
- St. Pual's Sinus Centre — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Atenea Pascual, PhD
- Email: apascual@providencehealth.bc.ca
- Phone: 604-806-9926
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.