Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501807
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-21
Brief Title:
BIOlogics in Severe Nasal POlyposis SurvEy a French Registry
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOPOSE2
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 compliancePatient-reported outcomes will be addressed according to their initial clinical profile allergy asthma NSAID gastroesophageal reflux disease obstructive apnea otologic disorder smoke habit
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 compliancePatient-reported outcomes will be addressed according to their initial clinical profile allergy asthma NSAID gastroesophageal reflux disease obstructive apnea otologic disorder smoke habit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None