About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval.
The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected
Disqualifiers
Oral corticotherapy in the previous month;
Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP;
Hypersensitivity to humanized antibodies ;
Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;
Trial design
Single group
Treatments tested in this trial
Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).
DrugDrug prescription according to their marketing approval (subcutaneously, every month or every two weeks).
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
Patient reported symptoms measurement
Number of oral corticosteroid treatment courses between each visit (in grammes)
Time to first surgical procedure since the beginning of biologic treatment
Date and type of sinus surgery between each visit
Blood eosinophil count and total IgE blood concentrations evolution during the course of the 5-year follow-up
Number off cells per mm3
Sponsors and contacts
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