Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment

Launched by ST. PAUL'S SINUS CENTRE · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called Mepolizumab affects the immune system of patients with Chronic Rhinosinusitis, particularly those who also have nasal polyps. Researchers want to understand the differences in immune responses between patients with nasal polyps (CRSwNP) who have asthma and those who have asthma but not nasal polyps (CRSsNP). By looking at these differences before and after treatment, the study aims to find out how effective Mepolizumab is in improving the condition.

To participate in this study, individuals must be over 19 years old and have either CRSwNP with or without asthma, or CRSsNP with asthma (though only CRSsNP patients will not receive the treatment). Important criteria include having a confirmed asthma diagnosis and being willing to use birth control if they could become pregnant. Participants can expect to undergo assessments and monitoring during the study, which is currently recruiting individuals of any gender. Keep in mind that certain health conditions, like current or past cancers, autoimmune diseases, and recent antibiotic use, may exclude someone from participating in the trial.

Gender

ALL

Eligibility 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