A Phase 4 interventional study of Mepolizumab and Placebo in Chronic Rhinosinusitis With Nasal Polyps, Asthma and Chronic Rhinosinusitis Without Nasal Polyps, sponsored by St. Paul's Sinus Centre. Recruiting at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by St. Paul's Sinus Centre · Phase 4, Interventional, and Treatment
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.
The proposed design is a 24-week randomized, double-blind, placebo-controlled, parallel-group study to compare the molecular profiles of CRSwNP patients with or without asthma after Mepolizumab treatment. Subjects must sign an informed consent before any study-related procedure is performed. At visit 1 (Screening) nasoendoscopy procedure, blood test analysis, and asthma history evaluation will be performed for all subjects. Newly diagnosed asthma patients will be confirmed by specific tests (methacholine and atopy test) between screening and baseline visits. Subjects who meet eligibility criteria at Visit 2 (Baseline) will be randomized to receive either mepolizumab or placebo in addition to standard-of-care CRS treatment using block randomization through REDCap. This study will be blinded to the PI, the patient, and one of the research coordinators. The blinded research coordinator will be responsible for randomizing the study subjects using REDCap.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 90 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →St. Paul's Sinus Centre is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with CRSwNP with or without asthma:
Patients with CRSsNP with asthma:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mepolizumab (100 mg) subcutaneously every 4 weeks
Biological: Mepolizumab
Placebo 100 mg subcutaneously every 4 weeks
Other: Placebo
Mepolizumab will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks
Placebo will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks
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)
Time frame: 24 weeks
Explore the effects of Mepolizumab compared to placebo in the treatment of Chronic Rhinosinusitis
Mean change from baseline in Modified Lund-Kennedy (MLK) endoscopic scores
Time frame: 24 weeks
Explore the effects of Mepolizumab compared to placebo in the treatment of Chronic Rhinosinusitis
Mean change from baseline in the 22-item Sino Nasal Outcome Test (SNOT-22)
Time frame: 24 weeks
Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.
Mean change from baseline in MLK
Time frame: 24 weeks
Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.
Mean change from baseline in SNOT-22
Time frame: 24 weeks
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Studies of the drug tested here: Mepolizumab
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