Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment

NCT05642806 | Recruiting Phase 4

• 1 other identifier: H20-03358
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

asthma; chronic rhinosinusitis; nasal polyps; mepolizumab

Outcome Measures

Primary Outcomes (1)

• Compare the immune profile in CRSwNP patients with and without asthma (before and after Mepolizumab treatment), and with asthmatic CRSsNP patients.

  • Mean change from baseline in key inflammatory cytokines measured by the Luminex Bio-Plex Pro Human Cytokine Multi-Plex (the specific cytokine targets for this assay include: IL-1β, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17, basic FGF, eotaxin, G-CSF, GM-CSF, IFNγ, IP-10, MCP-1 (MCAF), MIP-1α, MIP-1β, PDGF-BB, RANTES, TNF-α, VEGF)

  24 weeks

Secondary Outcomes (4)

• Explore the effects of Mepolizumab compared to placebo in the treatment of Chronic Rhinosinusitis

  24 weeks

• Explore the effects of Mepolizumab compared to placebo in the treatment of Chronic Rhinosinusitis

  24 weeks

• Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.

  24 weeks

• Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.

  24 weeks

Study Arms (2)

Mepolizumab

EXPERIMENTAL

Mepolizumab (100 mg) subcutaneously every 4 weeks

Biological: Mepolizumab

Placebo

PLACEBO COMPARATOR

Placebo 100 mg subcutaneously every 4 weeks

Other: Placebo

Interventions

Mepolizumab BIOLOGICAL

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

Mepolizumab

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Paul's Sinus Centre: lead

Study Sites (1)

St. Pual's Sinus Centre

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Asthma; Nasal Polyps

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Atenea Pascual, PhD

CONTACT

604-806-9926; apascual@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study pharmacist and one of the research coordinators will be unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Randomized, double-blind, placebo-controlled, parallel-group study

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 8, 2022
• Study Start: July 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CA (1)