An observational study in Chronic Rhinosinusitis With Nasal Polyps, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 27 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-14.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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, prospective/retrospective 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.
We included all patients that were referred to Mepolizumab therapy, prescribed accordingly to the plan provided by AIFA
Exclusion Criteria:
Drug: Mepolizumab Auto-Injector
Mepolizumab 100 mg in pre-filled injector
Also known as: Mepolizumab 100 mg
Nasal Polyp Score
Evaluation of polyps volume from 0 (minimum) to 4 (maximum) points for each nasal cavity. Reduced score indicates improvement
Time frame: 24 months
Sinonasal Outcome Test - 22
Questionnaire measuring health-related quality of life. The score is from 0 (minimum) to 110 (maximum). Reduced score indicates improvement
Time frame: 24 months
Visual Analogue Scale for nasal obstruction
Evaluation of nasal obstruction from 0 (minimum) to 10 (maximum) ;reduced score indicates improvement
Time frame: 24 moths
Nasal Congestion Score (NCS); score (range 0-3);
Evaluation of nasal congestion educed score indicates improvement
Time frame: 24 months
Visual Analogue Scale for smell
Evaluation of olfaction impairment from 0 (minimum) to 10 (maximum); reduced score indicates improvement
Time frame: 24 months
Sniffing sticks identification test
Test of nasal chemosensory performance based on pen-like odor dispensing devices. From 0 (minimum ) to 16 (maximum); increased score indicates improvement.
Time frame: 24 months
Change in blood eosinophil count
Change in blood eosinophil count in a complete blood count (CBC)
Time frame: 24 months
Adherence to drug therapy with Mepolizumab
Number of missing injection in a year
Time frame: 24 months
Need for rescue oral corticosteroids
Number of oral corticosteroids cycles during therapy
Time frame: 24 months
Need for surgery
Number of surgeries performed during therapy
Time frame: 24 months
Plan to share: Undecided
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS