Recruiting

Mepolizumab

Sponsor:

St. Paul's Sinus Centre

Code:

NCT05642806

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Asthma

Chronic Rhinosinusitis Without Nasal Polyps

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Mepolizumab

Placebo

Study Details

Brief 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Asthma

Chronic Rhinosinusitis Without Nasal Polyps

Study ID

NCT05642806

Start date

Jul 1, 2023

Status verified date

Apr, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mepolizumab

Mepolizumab (100 mg) subcutaneously every 4 weeks

placebo comparator: Placebo

Placebo 100 mg subcutaneously every 4 weeks

Interventions

Mepolizumab

Mepolizumab will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks

Placebo

Placebo will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks

Primary outcome measure

  • Compare the immune profile in CRSwNP patients with and without asthma (before and after Mepolizumab treatment), and with asthmatic CRSsNP patients. [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

St. Pual's Sinus Centre

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

More Information

Sponsor

St. Paul's Sinus Centre

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Keywords

  • asthma
  • chronic rhinosinusitis
  • nasal polyps
  • mepolizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Paul's Sinus Centre on 2024-04-17.