BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval)..
- Who it may be relevant to
- Registry conditions: Rhinosinusitis Chronic, Nasal Polyps. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
Overview
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).
Interventions
- Drug Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).
Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks).
Primary outcome measures
- Comparison of quality of life over 5 years according to the asthmatic status of the patients [Time frame: 5-year follow-up]
Secondary outcome measures (4)
- Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps [Time frame: Evaluation after 6 months of treatment with biologics]
- Patient reported symptoms measurement [Time frame: Month 0, Month 3, Month 6, and every 6 months until 5 years]
- Time to first surgical procedure since the beginning of biologic treatment [Time frame: 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 [Time frame: Month 0, Month 3, Month 6, and every 6 months until 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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;
- Pregnant or breast-feeding women;
- Patient without social coverage.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- CHU de Lille — Lille
- chu de Lille — Lille
Identifiers
NCT: NCT06501807 · 2023_0682