Active — Not RecruitingPhase 4

Mepolizumab to CRSwNP Through 12 Months - Randomised to FESS and Non-FESS Within the First 2 Weeks

Denmark58 participantsStarted 2023-04-01

Plain-language summary

This clinical trial will compare treatment in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma. The patients will be randomized to treatment with the biologic drug, Mepolizumab, or the biologic drug Mepolizumab combined with Functional Endoscopic Sinus Surgery (FESS). The aim of this study is to evaluate the effect of combined treatment with biologic treatment and surgery vs. biologic treatment only. The hypothesis is that surgical removal of polyps and inflamed tissue from the nasal sinuses will increase the effect of the biologic treatment, leading to a lower disease burden after 6 months of treatment, compared with biologic drugs only. Furthermore, combined biologics and surgery will keep a lower disease burden and better general health after 12 months of treatment than biologics alone. Inclusion criteria: * Patients ≥ 18 years old at the time of signed informed consent (no upper limit) * Patients who are referred to the outpatient clinic for the following reasons: * Doctor's diagnosis of CRS * NPS ≥ 2+2 out of a score of 8 (max) * Severity measured as an SNOT22 score \> 35 * One FESS in general anaesthesia performed prior to inclusion (no time limitations) * No course of systemic steroids within the last 3 months, whereas a daily low dose is allowed * Possible doctor's diagnosis of asthma * Type 2 inflammation Exclusion criteria: * Patients who, because of language barriers, are not able to understand written information and, thus, are not able to answer questionnaires * Patients who currently receive biologics for any other disease * Patients who have previously or currently received biologics for CRS or asthma * Patients who are not able to give informed consent (i.e., patients who are permanently incapable) * Patients who meet ≥1 of the following: * Malignant lung disease * Cardiac disease of clinical importance * Current pregnancy and breastfeeding, as well as planning to be pregnant in the near future * Unwillingness to have FESS performed * Patients needing FESS or systemic steroids (OCS) during the study period will be excluded after an unscheduled visit (last observation carried forward (LOCF)) * Patients who are not eligible because of the investigator's judgement The effect of the treatment will be evaluated with objective procedures and questionnaires related to CRSwNP and asthma after 3, 6 and 12 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients ≥ 18 years old at the time of signed informed consent (no upper limit) * Patients who are referred to the outpatient clinic for the following reasons: * Doctor's diagnosis of CRS * NPS ≥ 2+2 out of a score of 8 (max) * Severity measured as an SNOT22 score \> 35 * One FESS surgery in general anaesthesia performed prior to inclusion (no time limitations) * No course of systemic steroids within the last 3 months, whereas a daily low dose is allowed * Possible doctor's diagnosis of asthma * Type 2 inflammation Exclusion Criteria: * Patients who, because of language barriers, are not able to understand written information and, thus, are not able to answer questionnaires * Patients who currently receive biologics for any other disease * Patients who have previously or currently received biologics for CRS or asthma * Patients who are not able to give informed consent (i.e., patients who are permanently incapable) * Patients who meet ≥1 of the following: * Malignant lung disease * Cardiac disease of clinical importance * Current pregnancy and breastfeeding, as well as planning to be pregnant in the near future * Unwillingness to have FESS performed * Patients needing FESS or systemic steroids (OCS) during the study period will be excluded after an unscheduled visit (last observation carried forward (LOCF)) * Patients who are not eligible because of the investigator's judgement

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score

Timeframe: 6 months

Trial details

NCT IDNCT05598814

SponsorVibeke Backer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-31

View on ClinicalTrials.gov More Chronic Rhinosinusitis with Nasal Polyps trials