BIOlogics in Severe Nasal POlyposis SurvEy

Last updated: April 4, 2022
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sinusitis

Polyps

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT05228041
DRI_2021/0030
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 inflammatorydiseases 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 olfactorydisorders related to COVID;
  • Pregnant or breast-feeding women;
  • Patient without social coverage

Study Design

Total Participants: 100
Study Start date:
February 10, 2022
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Hop Claude Huriez Chu Lille

    Lille, 59037
    France

    Active - Recruiting

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