BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry

NCT06501807 | Not Yet Recruiting

• 1 other identifier: 2023_0682
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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

Keywords

nasal polyp; chronic rhinosinusitis; eosinophil; endotype

Outcome Measures

Primary Outcomes (1)

• 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

  5-year follow-up

Secondary Outcomes (4)

• Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps

  Evaluation after 6 months of treatment with biologics

• Patient reported symptoms measurement

  Month 0, Month 3, Month 6, and every 6 months until 5 years

• Time to first surgical procedure since the beginning of biologic treatment

  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

  Month 0, Month 3, Month 6, and every 6 months until 5 years

Study Arms (1)

Biologic treatments available

OTHER

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

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

Interventions

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

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

Biologic treatments available

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHU de Lille

Lille, France

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

dupilumab; mepolizumab

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Geoffrey Mortuaire, MD, pHD

CONTACT

0320445675; geoffrey.mortuaire@chru-lille.fr

Geoffrey Mortuaire

CONTACT

0320445675; geoffrey.mortuaire@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: July 15, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): September 2, 2034
• Study Completion (Estimated): January 2, 2035
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

FR (1)