drugset / Trial / NCT06501807

BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry

NCT06501807

Recruiting 900 enrolled University Hospital, Lille
NaSingle-groupOpen-labelTreatment

Summary

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed. During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production. New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies. Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).

Timeline

Start
2024-07-11
Primary completion
2034-09-02
Completion
2035-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Benralizumab Monoclonal antibody Subcutaneous
Subject Dupilumab Monoclonal antibody Subcutaneous
Subject Mepolizumab Monoclonal antibody Subcutaneous