Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05938972

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
See also
  Status Clinical Trial Phase
Recruiting NCT05895929 - The Role of IL5 in Epithelial Cell Integrity Early Phase 1
Active, not recruiting NCT05891483 - Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps Phase 2
Active, not recruiting NCT04998604 - EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients Phase 4
Recruiting NCT06069310 - Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis, Nasal Polyps and Comorbid Severe Eosinophilic Asthma
Recruiting NCT05009758 - Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps N/A
Active, not recruiting NCT05529784 - Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)
Recruiting NCT05902325 - Identifying Predictors Of Response To Mepolizumab In CRSwNP Phase 4
Completed NCT05049122 - Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52) Phase 4
Not yet recruiting NCT05598411 - CST1-Guided Oral Glucocorticoids Management for CRSwNP Phase 4
Active, not recruiting NCT05553951 - Adherence in Global Airways N/A
Recruiting NCT05131464 - The Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps Phase 2
Recruiting NCT05598424 - CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps Phase 4
Active, not recruiting NCT05649813 - A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region
Recruiting NCT04628442 - Tissue Immune Interaction in Nasal Polyposis
Active, not recruiting NCT06118554 - 3D Printing to Improve Nasal Irrigation Outcome N/A
Active, not recruiting NCT04596189 - Dupilumab for Prevention of Recurrence of CRSwNP After ESS Phase 4
Recruiting NCT02668861 - Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels Phase 3
Active, not recruiting NCT05878093 - Dupilumab in Chinese Adult Participants With CRSwNP Phase 3
Completed NCT05931744 - The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis Phase 2/Phase 3
Not yet recruiting NCT05157412 - Role of Doxycycline in Chronic Rhinosinusitis With Nasal Polyps Phase 3