Optimisation of treatment in patients with chronic rhinosinusitis with nasal polyps. A clinical trial investigating the difference between biological treatment with Mepolizumab and Functional endoscopic sinus surgery (FESS) versus biological treatment with mepolizumab without sinus surgery.

Optimisation of treatment in patients with CRSwNP. An RCT of mepolizumab and surgical treatment with FESS and mepolizumab versus only mepolizumab over a 6- and 12-month follow-up

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002923-37-DK

Enrollment

Registered

2022-11-17

Start date

2023-04-25

Completion date

Unknown

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma MedDRA version: 20.1 Level: PT Classification code 10080060 Term: Chronic rhinosinusitis with nasal polyps System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Mepolizumab Product Name: Mepolizumab Product Code: EMEA/H/C/003860-IB/0051 Pharmaceutical Form: Injection INN or Proposed INN: Mepolizumab CAS Number: 196078-29-2 Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

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: o 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

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: o Malignant lung disease o Cardiac disease of clinical importance o Current pregnancy and breastfeeding, as well as planning to be pregnant in the near future o 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective is to show better disease control in patients with CRSwNP who have received both biologic treatment and surgery compared with patients who have received biologic treatment only at the 6-month follow-up. Another objective is to examine the differences in CRS control after 12 months, as indicated by SNOT22, between the two different treatments (biologic/surgery vs. biologics only) to examine the sustainability of combined treatment.;Secondary Objective: not applicable;Primary end point(s): A significant change in HRQL using SNOT22 after a 6-month follow-up;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: The objective is to show better disease control in patients with CRSwNP who have received both biologic treatment and surgery compared with patients who have received biologic treatment only at the 6-month follow-up. Another objective is to examine the differences in CRS control after 12 months, as indicated by SNOT22, between the two different treatments (biologic/surgery vs. biologics only) to examine the sustainability of combined treatment.;Secondary Objective: not applicable;Primary end point(s): A significant change in HRQL using SNOT22 after a 6-month follow-up;Timepoint(s) of evaluation of this end point: 6 months

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Secondary

Measure	Time frame
Secondary end point(s): To evaluate variables such as NPS, NCS, sense of smell, sleep, middle ear pressure, exacerbation, use of extra steroids, ACQ and inflammatory biomarkers in blood, sputum and polyp tissue, after 12 months, as well as SNOT22 and VAS differences will be examined in patients from both treatment arms, and the differences between the two treatments will be analysed. The need for surgical intervention or systemic steroids in the FESS group versus the non-FESS group between 6 and 12 months will be analysed. A change in adherence to the baseline treatment after 12 months of biologic drug treatment will be measured. A change in the CT scan of the sinuses after 12 months of biologic treatment (score based) using the Lund Mackay scale (0 to 24, higher = worse) compared with CT scan prior to treatment will be checked. ;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Secondary end point(s): To evaluate variables such as NPS, NCS, sense of smell, sleep, middle ear pressure, exacerbation, use of extra steroids, ACQ and inflammatory biomarkers in blood, sputum and polyp tissue, after 12 months, as well as SNOT22 and VAS differences will be examined in patients from both treatment arms, and the differences between the two treatments will be analysed. The need for surgical intervention or systemic steroids in the FESS group versus the non-FESS group between 6 and 12 months will be analysed. A change in adherence to the baseline treatment after 12 months of biologic drug treatment will be measured. A change in the CT scan of the sinuses after 12 months of biologic treatment (score based) using the Lund Mackay scale (0 to 24, higher = worse) compared with CT scan prior to treatment will be checked. ;Timepoint(s) of evaluation of this end point: 12 months

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Countries

Denmark

Contacts

Public ContactDepartment of Otorhinolaryngology,

Rigshospitalet

nina.vibeke.backer@regionh.dk+4535456033

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026