BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry
NCT Number: NCT06501807
Acronym: BIOPOSE2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rhinosinusitis Chronic|Nasal Polyps
Interventions: DRUG: Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).
Sponsor: University Hospital, Lille
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2035-01-02
Locations: CHU de Lille, Lille, France

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).

Primary Outcome Measures: Comparison of quality of life over 5 years according to the asthmatic status of the patients, Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome, 5-year follow-up
Secondary Outcome Measures: Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps, Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome, Evaluation after 6 months of treatment with biologics|Patient reported symptoms measurement, Number of oral corticosteroid treatment courses between each visit (in grammes), Month 0, Month 3, Month 6, and every 6 months until 5 years|Time to first surgical procedure since the beginning of biologic treatment, Date and type of sinus surgery between each visit, MMonth 0, Month 3, Month 6, and every 6 months until 5 years|Blood eosinophil count and total IgE blood concentrations evolution during the course of the 5-year follow-up, Number off cells per mm3, Month 0, Month 3, Month 6, and every 6 months until 5 years