MEPOLIZUMAB for Eosinophilic granulomatosis with polyangiitis (EGPA)|Granulomatosis with polyangiitis (GPA)|Chronic rhinosinusitis with nasal polyps (CRSwNP)|Severe asthma|Healthy control

Inclusion criteria

• {"criterion_text":"- >18 years of age\n- Able to give informed consent\n- In CRSwNP group: availability of bilateral nasal polyps as diagnosed by endoscopy or CT scan\n- In Severe asthma group: clinical diagnosis of asthma with FEV1 <80% AND either FEV1 reversibility >12% initial or documented positive metacholine challenge (PC20 < 8 mg/ml)\n- In eGPA group: Fulfilling the 2022 ACR/EULAR criteria for eGPA (Wechsler et al., 2017)\n- In GPA group: fulfilling the ACR/EULAR GPA criteria (Robson et al., 2022)\n- In healthy controls: absence of asthma symptoms, no bronchial hyperresponsiveness"}

Exclusion criteria

• {"criterion_text":"- Unable to give informed consent\n- Active smoking < (less than) 6 months from baseline visit\n- Pregnant or breastfeeding woman\n- In CRSwNP group: current use of asthma medication, eGPA\n- In healthy controls: chronic use of local anti-inflammtory agents\n- In healthy controls: use of immunosuppressive medication\n- In healthy controls: use of antibiotics within the last month (before start study/screening/)\n- concomitant use of dupilumab within 6 months of baseline visit"}

Primary endpoints

• {"endpoint_text":"- The effect mepolizumab treatment has on the nasal microbiome profiles after three months of treatment","definition_or_measurement_approach":"Assessment of nasal microbiome profiles after three months of mepolizumab treatment (measured as changes in nasal microbiome profiles at the three-month timepoint)."}

Netherlands

Earliest CTIS Part Ii Submission Date

30-01-2024

Latest Decision Or Authorization Date

02-02-2024

Processing Time Days

3

Number Of Sites

1

Number Of Participants

150

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands