Nasal Polyps Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
chu de Lille
RECRUITING
Lille
CHU de Lille
ACTIVE_NOT_RECRUITING
Lille
Contact Information
Primary
Geoffrey Mortuaire, MD, pHD
geoffrey.mortuaire@chru-lille.fr
0320445675
Backup
Geoffrey Mortuaire
geoffrey.mortuaire@chru-lille.fr
0320445675
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2035-01-02
Participants
Target number of participants: 900
Treatments
Other: Biologic treatments available
Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval).
Sponsors
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov