RecruitingPhase 4NCT05642806
Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment
Sponsor
St. Paul's Sinus Centre
Enrollment
90 participants
Start Date
Jul 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study aims to analyze the immune profiles of patients with Chronic Rhinosinusitis with Nasal polyps (CRSwNP) with and without asthma before and after Mepolizumab. A group of participants with CRS without nasal polyps (CRSsNP) with asthma will be included to compare their immune profiles to CRSwNP.
Eligibility
Min Age: 19 Years
Inclusion Criteria7
- Are over the age of 19.
- 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.
- Patients with CRSsNP with asthma:
- These patients will not take the study treatment and they will only complete screening and baseline visits.
- 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 Criteria9
- Current or past sinonasal or bronchial tumours
- Subjects who have been treated with oral antibiotics in the past month prior to surgery.
- Subjects with known immunodeficiency
- Subjects with known autoimmune disease
- Smoking history; current or former smokers.
- Prior lung transplants
- Subjects with parasitic (helmintic) infection
- Subjects with hypersensitivity; with allergy/intolerance to a monoclonal antibody or biologic
- Female participants who are pregnant or breastfeeding
Interventions
BIOLOGICALMepolizumab
Mepolizumab will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks
OTHERPlacebo
Placebo will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05642806
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