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ID
Source
Brief title
Health condition
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
To define phenotypical differences in the peripheral blood and nasal polyp ILC2s, eosinophils, basophils, and mast cells between responders and non-responders to dupilumab
Background summary
Observational exploratory study of 91 consecutively included adult patients (≥ 18 years) treated with dupilumab for their CRSwNP as indicated by the ruling guideline EPOS2020. We compare the type-2 inflammation in peripheral blood an nasal polyps at baseline and after 6 months of therapeutic responders with poor responders by histochemical and single cell suspension flow cytometry analysis. The study aims to: 1) identify predicting phenotypical and endotypical biomarkers for the therapeutic response to dupilumab; and 2) define phenotypical differences in the peripheral blood and nasal polyp ILC2s, eosinophils, basophils, and mast cells between responders and poor responders. Therapeutic response is assessed by questionnaires and clinical parameters.
Study objective
Therapeutic responders of dupilumab for CRSwNP have a different endo- and phenotype substrate of the type-2 inflammation than slow or poor responders as can be assessed by peripheral blood and nasal polyp tissue.
Study design
Materials: baseline, 6 months.
Questionnaires: baseline, 1, 2, 3 and 6 months.
Intervention
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.
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
• 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
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9302 |
| Other | METC AMC : METC 2020_254 |