Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258772
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-02-02
Brief Title:
Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP a Multicentric Real Life Observational Study
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Effectiveness of Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP a Multicentric Real Life Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
MEPOREAL
Brief Summary:
Chronic rhinosinusitis with nasal polyposis CRSwNP is a complex chronic inflammatory disease of the nasosinusal mucosa that has a significant negative impact on patients quality of life
In CRSwNP chronic inflammation is primarily driven by type 2 pro-inflammatory interleukins ILs such as IL-5 IL-4 and IL-13 along- side high levels of eosinophils in the surrounding tissue Mepolizumab is a targeted humanized anti-IL-5 antibody that prevents IL-5 from binding to its receptor on eosinophils and selectively inhibits eosinophilic inflammation
So far randomized clinical trials have assessed efficacy and safety of Mepolizumab in a large number of patients whereas evidences in real life clinical practice are limited to few monocentric series
Herewith we present a multicenter observational prospectiveretrospective nationwide real-life study with the aim to confirm the effectiveness and the safety of Mepolizumab over the first year of treatment in a real life setting
The primary objective of this study is to evaluate the reduction of dimension of nasal polyps and the improvement of quality of life in the patient measured through symptomatologic questionnaires
The secondary objective is to evaluate improvements in terms of smell dysfunction comorbidities biomarkers nasal cytology and blood eosinophilia need of surgery or systemic steroids
In CRSwNP chronic inflammation is primarily driven by type 2 pro-inflammatory interleukins ILs such as IL-5 IL-4 and IL-13 along- side high levels of eosinophils in the surrounding tissue Mepolizumab is a targeted humanized anti-IL-5 antibody that prevents IL-5 from binding to its receptor on eosinophils and selectively inhibits eosinophilic inflammation
So far randomized clinical trials have assessed efficacy and safety of Mepolizumab in a large number of patients whereas evidences in real life clinical practice are limited to few monocentric series
Herewith we present a multicenter observational prospectiveretrospective nationwide real-life study with the aim to confirm the effectiveness and the safety of Mepolizumab over the first year of treatment in a real life setting
The primary objective of this study is to evaluate the reduction of dimension of nasal polyps and the improvement of quality of life in the patient measured through symptomatologic questionnaires
The secondary objective is to evaluate improvements in terms of smell dysfunction comorbidities biomarkers nasal cytology and blood eosinophilia need of surgery or systemic steroids
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None