Chronic Rhinosinusitis With Nasal Polyps
Conditions
Keywords
Biologic, nasal polyp, chronic rhinosinusitis, eosinophil, endotype
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.
Detailed description
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.
Interventions
DRUGBiologic 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)
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | number of treatment sequencies |
| Delay to first surgical procedure | Day 0, Month 3, Month 6, Month 12 and Month 18 | time between biologic onset and need for surgery |
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGeoffrey Mortuaire, MD
University Hospital, Lille
Outcome results
None listed