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Italian registry of adults with severe, uncontrolled chronic rhinosinusitis

Collects information over time on adults with uncontrolled chronic rhinosinusitis in Italy.

Key facts

Who runs it
Italian Academy of Rhinology
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
Status
Recruiting
People taking part
5,000 people, planned
Started
1 Nov 2021
Expected to end
31 Oct 2031
Type of study
Observational
Treatments tested
  • Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)
Record updated
19 July 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe chronic rhinosinusitis (long-lasting swelling of the nose and sinuses) on both sides that is not under control. It is a registry that collects data from patients seen at specialist centres in Italy.

Age
18 Years and older
Sex
All sexes
Disease stage
Confirmed chronic rhinosinusitis on both sides. People who had sinus surgery need at least 3 of the listed signs; people who never had it need at least 4. Signs: type 2 inflammation, steroid tablet use, much worse quality of life (SNOT-22 >= 40 and/or Global VAS of symptoms >= 5), and loss of smell (VAS for hyposmia >= 7).
Earlier treatment
One of the listed signs is at least two short courses or long-term use of systemic corticosteroids (steroids taken by mouth or injection) for chronic rhinosinusitis. Earlier nasal sinus surgery changes how many signs are needed.
Biomarker or test result
One listed sign is type 2 inflammation: at least 250 blood eosinophils per microliter, and/or at least 10 eosinophils / HPF in a sinus tissue sample, and/or moderate eosinophilia on nasal cytology, and/or total serum IgE >100 IU / ml.

The registry criteria, word for word

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Who can take part

  • 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)

Who cannot take part

  • -

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

This real-life chronic rhinosinusitis registry aims at longitudinal data collection from patients attending specialist care centres across Italy.

Treatments tested

  • Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Rhinosinusitis Italian Network (RINET): the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
Plain-language title
Italian registry of adults with severe, uncontrolled chronic rhinosinusitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
19 July 2024