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

NCT ID: NCT05598814

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-08-31

Brief 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.

Conditions

Chronic Rhinosinusitis with Nasal Polyps; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group - FESS

Biologic treatment with Mepolizumab and functional endoscopic sinus surgery (FESS).

Group Type: EXPERIMENTAL

Mepolizumab Injection

Intervention Type: BIOLOGICAL

All patients in both the intervention group and the control group will be treated with Mepolizumab injections every month.

Functional Endoscopic Sinus Surgery (FESS).

Intervention Type: PROCEDURE

The Functional Endoscopic Sinus Surgery will be performed 2 weeks after the first injection of Mepolizumab in the intervention group.

Control group - No-FESS

Biologic treatment with Mepolizumab

Group Type: ACTIVE_COMPARATOR

Mepolizumab Injection

Intervention Type: BIOLOGICAL

All patients in both the intervention group and the control group will be treated with Mepolizumab injections every month.

Interventions

Mepolizumab Injection

All patients in both the intervention group and the control group will be treated with Mepolizumab injections every month.

Intervention Type: BIOLOGICAL

Functional Endoscopic Sinus Surgery (FESS).

The Functional Endoscopic Sinus Surgery will be performed 2 weeks after the first injection of Mepolizumab in the intervention group.

Intervention Type: PROCEDURE

Eligibility 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:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vibeke Backer

OTHER

Sponsor Role: lead

Responsible Party

Vibeke Backer

Professor, Pulmonologist, MD, DMSc (PI)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vibeke B Backer, Professor

Role: STUDY_CHAIR

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet

Locations

Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

2022-ENT-FESS-nonFESS

Identifier Type: -

Identifier Source: org_study_id