Clinical Research Directory

Effectiveness on Sino-Nasal Symptoms Of Mepolizumab 300

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Summary

OBJECTIVES The primary objective of this study is evaluating the reduction of dimension of nasal polyps measured with Nasal Polyp Endoscopic Score (NPS) The secondary objective is to evaluate the improvement in nasal symptoms and quality of life in the patient measured through symptom questionnaires, the improvements in terms of smell dysfunction and symptomatology related to eosinophilic otitis media;evaluate the need of surgery or systemic corticosteroids. ENDPOINTS Primary endpoint The primary endpoints will be the Improvement of NPS score (indicative of polyps score reduction) at 12 months after start of therapy. Secondary endpoints * Improvement of SNOT-22 score (indicative of an improvement in quality of life) * Improvement of VAS score for nasal obstruction * Improvement of Nasal Congestion Score (NCS) * Improvement of VAS score for smell; * Improvement of sniffin' sticks score; * Evaluate adherence to drug therapy with Mepolizumab 300, any suspension of the same and reasons for discontinuing treatment (lack of efficacy, complications reported, safety profile); * Assess how many patients require FESS surgery and/or systemic steroids for sino-nasal symptoms during treatment; * Evaluate the improvement of symptoms of any associated comorbidities and in particular chronic eosinophilic otitis media. Study design Observational, retrospective/prospective, non-profit and national multicenter real-life study.

Official title: Effectiveness on Sino-Nasal Symptoms Of Mepolizumab 300 In Patients Affected by Egpa and Concomitant Severe and Uncontrolled CRSwNP: Italian Multicentric "Real-Life" Observational Study

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