Actively Recruiting

Age: 18Years +
All Genders
NCT05935683

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

Led by Italian Academy of Rhinology · Updated on 2024-07-19

5000

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

I

Italian Academy of Rhinology

Lead Sponsor

A

Accademia Italiana di Citologia Nasale

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with confirmed bilateral Chronic Rhinosinusitis diagnosis
  • Patients previously treated with nasal sinus surgery must have at least three of these criteria
  • Patients never treated with nasal sinus surgery must have at least four of these criteria
  • Evidence of type 2 inflammation shown by blood or tissue eosinophils, nasal cytology, or high serum IgE
  • At least two short courses or long-term systemic corticosteroid therapy for Chronic Rhinosinusitis
  • Significant quality of life worsening (SNOT-22 score of 40 or higher and/or symptom severity score of 5 or higher)
  • Loss of smell with a severity score of 7 or higher
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital

Rozzano, MIlan, Italy, 20089

Actively Recruiting

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Research Team

E

Enrico Marco Heffler, MD, PhD

CONTACT

C

Concetta Sirena, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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