Survey on biologic treatments for severe nasal polyps
Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
This study is testing how well biologic treatments work for adults with severe nasal polyps to see if they can improve their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, benralizumab, dupilumab |
| Locations | 1 site (Lille) |
| Trial ID | NCT05228041 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of biologic treatments for patients suffering from Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). It focuses on patients over 18 years old who require biologic therapy, assessing their response to treatments such as dupilumab, mepolizumab, and benralizumab. The study will also explore the role of endotype profiling and biomarkers in tailoring these therapies to individual patients. By monitoring patient outcomes, the study seeks to enhance understanding of CRSwNP and improve treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who need biologic treatment for CRSwNP.
Not a fit: Patients who have received certain biologic treatments or corticosteroids recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with severe nasal polyps.
How similar studies have performed: Other studies have shown promising results with biologic treatments for similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille
- Hop Claude Huriez Chu Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Geoffrey Mortuaire, MD — University Hospital, Lille
- Study coordinator: Goeffrey Mortuaire, MD
- Email: geoffrey.mortuaire@chru-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.