BIOlogics in Severe Nasal POlyposis SurvEy
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Registration Number
- NCT05228041
- Lead Sponsor
- University Hospital, Lille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Day0, Month 6 from 0 to 110 , 110 = worst outcome
- Secondary Outcome Measures
Name Time Method SNOT 22 (Sinonasal Outcome Test-22) scores Day 0, Month 3, Month 6, Month 12 and Month 18 from 0 to 110 , 110 = worst outcome
Visual analogical scale (VAS) for nasal obstruction Day 0, Month 3, Month 6, Month 12 and Month 18 from 0 to 10, 10 = worst outcome
Visual analogical scale (VAS) for smell lost Day 0, Month 3, Month 6, Month 12 and Month 18 from 0 to 10, 10 = worst outcome
Visual analogical scale (VAS) for rhinorrhea Day 0, Month 3, Month 6, Month 12 and Month 18 from 0 to 10, 10 = worst outcome
Visual analogical scale (VAS) for craniofacial pain Day 0, Month 3, Month 6, Month 12 and Month 18 from 0 to 10, 10 = worst outcome
Number of systemic corticosteroid treatment courses between each visit Day 0, Month 3, Month 6, Month 12 and Month 18 Delay to first surgical procedure Day 0, Month 3, Month 6, Month 12 and Month 18 Blood eosinophil count Day 0, Month 3, Month 6, Month 12 and Month 18 number of cells per mm3
Blood total IgE concentrations Day 0, Month 3, Month 6, Month 12 and Month 18 concentration expressed by KUI/L
Trial Locations
- Locations (1)
Hop Claude Huriez Chu Lille
🇫🇷Lille, France