Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment
NCT ID: NCT05642806
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
90 participants
INTERVENTIONAL
2023-07-01
2025-06-30
Brief Summary
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A group of participants with CRS without nasal polyps (CRSsNP) with asthma will be included to compare their immune profiles to CRSwNP.
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Detailed Description
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In this visit, a nasal sample will be collected to measure the analysis of the inflammatory cytokine from the nasal secretions. This procedure will be repeated in the middle and end of treatment (week 8 and week 24). During the blind-treatment run-in period, study treatment will be administered at St Paul's Hospital every 4 weeks for 6 months. Participants will complete different questionnaires to measure the symptoms and social/emotional consequences of the subject's nasal disorder (SNOT- 22), health-related quality of life EuroQol-5 (EQ-5D), and an objective smell identification test (SIT). They will assess their global impression of change since starting the study drug using the Patient Global Impression of Change (PGIC) scale.
This study will also include 30 participants with CRSsNP with asthma that will not undergo any study procedure except the Screening and Baseline Visit to collect a nasal sample for cytokine analysis. These results will later be compared to those who positively responded to Mepolizumab.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mepolizumab
Mepolizumab (100 mg) subcutaneously every 4 weeks
Mepolizumab
Mepolizumab will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks
Placebo
Placebo 100 mg subcutaneously every 4 weeks
Placebo
Placebo will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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St. Paul's Sinus Centre
OTHER
Responsible Party
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Dr. Andrew Thamboo, MD
Clinical Assistant Professor
Locations
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St. Pual's Sinus Centre
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H20-03358
Identifier Type: -
Identifier Source: org_study_id
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