BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry

NCT ID: NCT06501807

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-02
• Study Completion Date: 2035-01-02

Brief 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).

Conditions

Rhinosinusitis Chronic; Nasal Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biologic treatments available

Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval).

Group Type: OTHER

Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).

Intervention Type: DRUG

Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks).

Interventions

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Lille

Lille, , France

Countries

France

Central Contacts

Geoffrey Mortuaire, MD, pHD

Role: CONTACT

geoffrey.mortuaire@chru-lille.fr

0320445675

Geoffrey Mortuaire

Role: CONTACT

geoffrey.mortuaire@chru-lille.fr

0320445675

Other Identifiers

2023_0682

Identifier Type: -

Identifier Source: org_study_id