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Real Life Study of Biologicals in Patients With Severe CRSwNP — NASUMAB  

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:
Real Life Study Assessing Long Term Outcomes and Predictive Factors of Response to Biologicals in Patients With Severe CRSwNP and/or Severe Allergic and/or Eosinophilic Asthma

Clinical Trial Summary

This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.

Clinical Trial Description

In this project, thanks to intense collaboration between the ENT department and the pulmonary diseases within the Allergy Network UZ Gent, the investigators set up a prospective study and biobank with the following aims: - To observe and follow-up on clinical characteristics in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) with or without asthma. Primary outcomes will be the endoscopic total nasal polyp score (NPS) and the nasal symptom scores (SNOT-22, VAS, NCS and UPSIT). - Identifying key nasal inflammatory biomarkers to predict therapeutic response to biologicals in CRSwNP patients (identification on blood samples, nasal secretions, small tissue biopsies and superficial scrapings before, during and at month 24 of treatment). - Unravel the effects of biologicals in the local nasal immune regulation. - Performing additional analyses to search for new biomarkers via complete proteomic analysis. Using a unique combination of nasal sampling and state of the art biomarker discovery, the investigators believe this research will provide unprecedented insights which will aid the treatment of patients with biologicals. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05938972
Study type Observational [Patient Registry]
Source University Hospital, Ghent
Contact Manon Blauwblomme, Masters
Phone +32 09 332 23 98
Email manon.blauwblomme@ugent.be
Status Recruiting
Phase
Start date March 1, 2022
Completion date December 31, 2030
View Details
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