Ireland
--:--IST
Latest
Clinical Trials in Italy / NCT05935683
Recruiting Observational

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

NCT05935683 · tracked via the Priya Life Science Italy tracker
Sponsor
Italian Academy of Rhinology
Phase
Observational
Started
2021-11-01
Last updated
2024-07-19

Condition(s) studied

Chronic Rhinosinusitis

Investigational drug(s) / intervention(s)

Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)

Severe Uncontrolled Chronic Rhinosinusitis patients (CRS): Obsertvation

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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: \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital Rozzano MIlan Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05935683 on ClinicalTrials.gov ↗ ← All trials in Italy