BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry

Официальное название

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

Обзор

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).

Вмешательства

• Препарат 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).

Первичные конечные точки

• Comparison of quality of life over 5 years according to the asthmatic status of the patients [Срок оценки: 5-year follow-up]

Вторичные конечные точки (4)

• Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps [Срок оценки: Evaluation after 6 months of treatment with biologics]
• Patient reported symptoms measurement [Срок оценки: Month 0, Month 3, Month 6, and every 6 months until 5 years]
• Time to first surgical procedure since the beginning of biologic treatment [Срок оценки: 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 [Срок оценки: Month 0, Month 3, Month 6, and every 6 months until 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• CHU de Lille — Lille
• chu de Lille — Lille

Идентификаторы

NCT: NCT06501807 · 2023_0682

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗