About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial population
Patients with Severe, Uncontrolled Chronic Rhinosinusitis with or without nasal polyps according to the European Position Paper on Rhinosinusitis and Nasal Polyps - EPOS2020 and to the EUFOREA consensus on biologics for CRSwNP with or without asthma
Trial design
Cohort
Prospective
Treatments tested in this trial
Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)
Other interventionObsertvation
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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Italian Academy of Rhinology
Lead sponsor
Accademia Italiana di Citologia Nasale
Collaborator