Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05228041

BIOlogics in Severe Nasal POlyposis SurvEy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: dupilumab, mepolizumab, omalizumab, tezepelumab

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

    Time frame: Day0, Month 6

    from 0 to 110 , 110 = worst outcome

Secondary outcomes

  1. SNOT 22 (Sinonasal Outcome Test-22) scores

    Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18

    from 0 to 110 , 110 = worst outcome

  2. Visual analogical scale (VAS) for nasal obstruction

    Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18

    from 0 to 10, 10 = worst outcome

  3. Visual analogical scale (VAS) for smell lost

    Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18

    from 0 to 10, 10 = worst outcome

  4. Visual analogical scale (VAS) for rhinorrhea

    Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18

    from 0 to 10, 10 = worst outcome

  5. Visual analogical scale (VAS) for craniofacial pain

    Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18

    from 0 to 10, 10 = worst outcome

  6. Number of systemic corticosteroid treatment courses between each visit

    Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18

    number of treatment sequencies

  7. Delay to first surgical procedure

    Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18

    time between biologic onset and need for surgery

  8. Blood eosinophil count

    Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18

    number of cells per mm3

  9. Blood total IgE concentrations

    Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18

    concentration expressed by KUI/L

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

Acronym: BIOPOSE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 8, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.