Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis

Study Overview
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Brief Summary
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This observatory aims to collect, as widely as possible, the Italian cases of patients with uncontrolled CRS. Patient will be enrolled by the centers of the Italian Network of Rhinosinusitis (Rhinosinusitis Italian Network: RINET), and they will be treated using a multidisciplinary team approach (allergists, otolaryngologists and pneumologists) in a real-world clinical set-up. This real-life chronic rhinosinusitis registry aims at longitudinal data collection from patients attending specialist care centres across Italy.

Detailed Description
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The primary objectives of the study are: to characterize and to describe the evolution of uncontrolled Chronic Rhinosinusitis (CRS); to facilitate and to characterize the phenotyping and endotyping of CRS; studying the efficacy and safety of the principal therapeutic strategies and approaches to uncontrolled CRS in real-life; supporting the development of diagnostic methodologies and innovative therapeutic strategies for CRS; to evaluate the clinical and economic-health impact of the different therapeutic approaches (including systemic corticosteroids) used for uncontrolled CRS; to describe factors associated with therapeutic choices and how much this factors influence natural history of the CRS; Studying and identifying biomarkers and predictors of response to different therapies; to increase the awareness of CRS in patients, in public opinion, in the national and international scientific community, and in the Italian clinical community of the otolaryngologists, the allergists and the pneumologists.

Official Title
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Rhinosinusitis Italian Network (RINET): the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Other: Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with a confirmed diagnosis of bilateral Chronic Rhinosinusitis that have at least three (in case of patients previously treated with surgical approaches) or four (in case of patients never treated with nasal sinus surgery) of the following criteria: Evidence of type 2 inflammation (at least 250 blood eosinophils per microliter and / or at least 10 eosinophils / HPF from a histological sample of sinus mucosa and / or at least one finding of moderate eosinophilia on nasal cytology and / or total serum IgE >100 IU / ml); at least two Short courses of systemic corticosteroids or lorg-term Systemic Corticosteroids therapy for Chronic Rhinosinusitis; Significant deterioration in the quality of life (Sinonasal Outcome Test 22 - SNOT-22>= 40 and / or Visual Analogue Scale - Global VAS of symptoms>= 5); Loss of Smell (VAS for hyposmia> = 7) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)|Obsertvation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Polyp Score | Change from baseline in total Nasal Polyp Score at year 1 to ten. The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy. | Every year to ten year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Tract Diseases, chronic rhinosinusitis with nasal polyps, chronic rhinosinusitis without nasal polyps, Otorhinolaryngologic Diseases, Paranasal Sinus Diseases, Sinusitis, Nose Diseases, chronic rhinosinusitis (diagnosis)