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

Recruitingn/aAges 18 Years - anyAllItalian Academy of Rhinology
NCT05935683 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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: \-
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What it tests

  • Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)
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Where

1 site
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital
Rozzano, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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