Chronic Rhinosinusitis With Nasal PolypsPhase 4NCT05642806
Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment
A Phase 4 study testing Mepolizumab in people with Chronic Rhinosinusitis With Nasal Polyps and Asthma, run by St. Paul's Sinus Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps, Asthma, Chronic Rhinosinusitis Without Nasal Polyps
- What is being tested?
- Mepolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2023to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Subjects with parasitic (helmintic) infection
- Subjects with hypersensitivity; with allergy/intolerance to a monoclonal antibody or biologic
- Female participants who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Pual's Sinus Centre
Vancouver, British Columbia, V6Z 1Y6
Athenea Pascual, PhD, apascual@providencehealth.bc.ca
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps, Asthma, Chronic Rhinosinusitis Without Nasal Polyps
- Being tested
- Mepolizumab, Placebo
- Keywords
- asthma, chronic rhinosinusitis, nasal polyps, mepolizumab
- Medical subject headings
- Asthma, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabBiological
Mepolizumab will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks
PlaceboOther
Placebo will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab | Experimental | Mepolizumab (100 mg) subcutaneously every 4 weeks Receives: Biological: Mepolizumab |
| Placebo | Placebo comparator | Placebo 100 mg subcutaneously every 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 weeks
Secondary outcomes (4)
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
Measured: 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)
Measured: 24 weeks
Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.
Mean change from baseline in MLK
Measured: 24 weeks
Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.
Mean change from baseline in SNOT-22
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Jul 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Paul's Sinus Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andrew Thamboo, MD, St. Paul's Sinus Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642806
- Sponsor's protocol ID
- H20-03358
- Status last verified
- Apr 2024
- First submitted
- 17 Nov 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment
- ClinicalTrials.gov ID
- NCT05642806
- Acronym / sponsor ID
- H20-03358
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps, Asthma, Chronic Rhinosinusitis Without Nasal Polyps
- Keywords
- asthma, chronic rhinosinusitis, nasal polyps, mepolizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- St. Paul's Sinus CentreUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab | Experimental | Biological: MepolizumabMepolizumab (100 mg) subcutaneously every 4 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 100 mg subcutaneously every 4 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are over the age of 19.
- Patients with CRSwNP with or without asthma:
- Patients with CRSsNP with asthma:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MepolizumabMepolizumab will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks | Biological | Mepolizumab |
| PlaceboPlacebo will be administered subcutaneously (SC) every 4 weeks for a total of 24 weeks | Other | Placebo |
Primary outcome
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
• 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)
4 secondary outcomes
Explore the effects of Mepolizumab compared to placebo in the treatment of Chronic Rhinosinusitis
Time frame: 24 weeks
Explore the effects of Mepolizumab compared to placebo in the treatment of Chronic Rhinosinusitis
Time frame: 24 weeks
Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.
Time frame: 24 weeks
Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepolizumab in people with Chronic Rhinosinusitis With Nasal Polyps and Asthma, run by St. Paul's Sinus Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atenea Pascual, PhD (604-806-9926, apascual@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.