BIOlogics in Severe Nasal POlyposis SurvEy

NCT05228041 | Active Not Recruiting

• 1 other identifier: DRI_2021/0030
• Study Type: observational
• Target: 100
• 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

Biologic; nasal polyp; chronic rhinosinusitis; eosinophil; endotype

Outcome Measures

Primary Outcomes (1)

• 6-month rate of patients with a SNOT-22 (Sinonasal Outcome test -22) score change over the minimal clinically important difference of 8.9 by comparison of SNOT-22 scores measured at Month 0 and Month 6

  from 0 to 110 , 110 = worst outcome

  Day0, Month 6

Secondary Outcomes (9)

• SNOT 22 (Sinonasal Outcome Test-22) scores

  Day 0, Month 3, Month 6, Month 12 and Month 18

• Visual analogical scale (VAS) for nasal obstruction

  Day 0, Month 3, Month 6, Month 12 and Month 18

• Visual analogical scale (VAS) for smell lost

  Day 0, Month 3, Month 6, Month 12 and Month 18

• Visual analogical scale (VAS) for rhinorrhea

  Day 0, Month 3, Month 6, Month 12 and Month 18

• Visual analogical scale (VAS) for craniofacial pain

  Day 0, Month 3, Month 6, Month 12 and Month 18

Interventions

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

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

Also known as: dupilumab, mepolizumab, omalizumab, tezepelumab

Eligibility Criteria

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

Study Population

Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval

You may qualify if:

• Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval

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 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

Related Publications (1)

• 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.

  PMID: 38749694 RESULT

MeSH Terms

Conditions

Nasal Polyps

Interventions

dupilumab; mepolizumab; Omalizumab; tezepelumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Geoffrey Mortuaire, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: February 8, 2022
• Study Start: February 10, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

FR (1)