mepolizumab for Chronic rhinosinusitis with nasal polyposis

Inclusion criteria

• {"criterion_text":"- Patients ≥ 18 years old at the time of signed informed consent (no upper limit)"}
• {"criterion_text":"- Patients who are referred to the outpatient clinic for the following reasons: o Doctor’s diagnosis of CRS1"}
• {"criterion_text":"- NPS ≥ 2+2 out of a score of 8 (max)"}
• {"criterion_text":"- Severity measured as an SNOT22 score > 35"}
• {"criterion_text":"- Type 2 inflammation (see below)"}
• {"criterion_text":"- One FESS surgery in general anaesthesia performed prior to inclusion (no time limitations)"}
• {"criterion_text":"- No course of systemic steroids within the last 3 months, whereas a daily low dose (5-10 mg) is allowed"}
• {"criterion_text":"- Possible doctor’s diagnosis of asthma2"}

Exclusion criteria

• {"criterion_text":"- Patients who, because of language barriers, are not able to understand written information and, thus, are not able to answer questionnaires"}
• {"criterion_text":"- Patients who currently receive biologics for any other disease"}
• {"criterion_text":"- Patients who have previously or currently received biologics for CRS or asthma"}
• {"criterion_text":"- Patients who are not able to give informed consent (i.e., patients who are permanently incapable)"}
• {"criterion_text":"- Patients who meet ≥1 of the following: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"}
• {"criterion_text":"- Patients needing FESS or systemic steroids (OCS) during the study period will be excluded after an unscheduled visit (last observation carried forward (LOCF))"}
• {"criterion_text":"- Patients who are not eligible because of the investigator’s judgement"}
• {"criterion_text":"- Reaction towards Mepolizumab and one or more of the adjuvants."}
• {"criterion_text":"- Pregnancy during the study will be excluded after an unscheduled visit (LOCF)"}

Primary endpoints

• {"endpoint_text":"- Change in SNOT-22 score, Nasal polyp score and smell","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

21-08-2024

Latest Decision Or Authorization Date

05-09-2025

Processing Time Days

380

Number Of Sites

1

Number Of Participants

58

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"","organisation_type":"Health care"}