NCT06501807 BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry
| NCT ID | NCT06501807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Rhinosinusitis Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2034-09-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 900 participants in total. It began in 2024-07-11 with a primary completion date of 2034-09-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).
Eligibility Criteria
Inclusion Criteria: * Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval. * The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected 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 of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP; * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06501807 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rhinosinusitis Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06501807 currently recruiting?
Yes, NCT06501807 is actively recruiting participants. Contact the research team at geoffrey.mortuaire@chru-lille.fr for enrollment information.
Where is the NCT06501807 trial being conducted?
This trial is being conducted at Lille, France, Lille, France.
Who is sponsoring the NCT06501807 clinical trial?
NCT06501807 is sponsored by University Hospital, Lille. The trial plans to enroll 900 participants.