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Активно (без набиране) NCT05228041

BIOlogics in Severe Nasal POlyposis SurvEy

Заболявания: Chronic Rhinosinusitis With Nasal Polyps

Спонсор: University Hospital, Lille

Налично на: БГ
Обобщение
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 we 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.
Описание
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 we 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.
Кой може да участва
Inclusion Criteria: * Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval 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 apart from ongoing biotherapies for severe asthma; * 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
Интервенции
Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)
DRUG
Места на провеждане 1
Франция (1)
Hop Claude Huriez Chu Lille
Lille
Технически детайли
Статус
Активно (без набиране)
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
10.02.2022
Крайна дата
01.07.2027
Регистрационен номер
NCT05228041
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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