Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Conditions
Interventions
No therapeutic interventions. Extra blood withdrawal during standard baseline and 6 months check-up phlebotomy and biopsy of nasal polyp tissue at baseline and 6 months.
Sponsors
Amsterdam UMC, location AMC
Eligibility
Inclusion criteria
Inclusion criteria: adult patients (= 18 years) with CRSwNP with an indication for biological treatment as per the ruling European guideline EPOS2020 who will be treated with dupilumab
Exclusion criteria
Exclusion criteria: • age = 17 years • patient is not able to complete the SNOT 22 questionnaire • strong indication for surgical treatment (e.g.: mucoceles) • systemic diseases affecting the nose (e.g.: GPA, EGPA, sarcoid, primary ciliary dyskinesia, cystic fibrosis) • antrochoanal polyps (isolated benign polyps originating from the mucosa of the maxillary sinus with a distinctive small stalk) • inverted papilloma and malignant polyps • acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit • use of systemic corticosteroids within 4 weeks before the inclusion visit • need for continuous systemic corticosteroid treatment for other disease than CRSwNP • systemic diseases preventing participation in the study (all comorbidities that have a higher impact on quality of life than CRSwNP and/or making the patient at risk during the study period) • other systemical medical treatments influencing disease or primary and secondary study outcome measurements such as (non-)selective immunosuppressants (e.g.: azathioprine, methotrexate) and other monoclonal antibodies other than dupilumab (e.g.: adalimumab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify predicting phenotypical and endotypical biomarkers for the response to dupilumab in adult patients with CRSwNP, by comparing the type 2 inflammation in the peripheral blood and nasal polyp tissue at baseline and after 6 months of treatment with dupilumab between responders and non-responders | — |
Secondary
| Measure | Time frame |
|---|---|
| To define phenotypical differences in the peripheral blood and nasal polyp ILC2s, eosinophils, basophils, and mast cells between responders and non-responders to dupilumab | — |
Contacts
Public ContactRik van der Lans
Amsterdam UMC, location AMC
Outcome results
None listed