BIOlogics in Severe Nasal POlyposis SurvEy

NCT ID: NCT05228041

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2027-07-31

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 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Biologic treatments available in CRSwNP (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

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

• 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

Principal Investigators

Geoffrey Mortuaire, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hop Claude Huriez Chu Lille

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Goeffrey Mortuaire, MD

Role: CONTACT

geoffrey.mortuaire@chru-lille.fr

0320445962 ext. +33

Facility Contacts

Role: primary

0320445962

References

Favier V, Daveau C, Carsuzaa F, Fieux M, Vandersteen C, Castillo L, Papon JF, de Gabory L, Saroul N, Verillaud B, Rumeau C, Jankowski R, Michel J, de Bonnecaze G, Lecanu JB, Coste A, Bequignon E, Malard O, Mortuaire G. Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey. BMJ Open. 2024 May 15;14(5):e083112. doi: 10.1136/bmjopen-2023-083112.

Reference Type: DERIVED

PMID: 38749694 (View on PubMed)

Other Identifiers

DRI_2021/0030

Identifier Type: -

Identifier Source: org_study_id