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

Launched by ITALIAN ACADEMY OF RHINOLOGY · Jun 29, 2023

Keywords

ClinConnect Summary

The Rhinosinusitis Italian Network clinical trial is studying patients with a condition called chronic rhinosinusitis (CRS) that is difficult to control. This study aims to gather information from patients across Italy who have severe CRS that hasn’t improved with standard treatments. Participants will be cared for by a team of specialists, including doctors who focus on allergies, ear, nose, and throat issues, and lung health, all working together to provide the best treatment in a real-world setting.

To be eligible for this trial, patients must be diagnosed with chronic rhinosinusitis affecting both sides of their nose and meet certain criteria, such as having high levels of specific inflammatory cells or having used steroid medications to manage their symptoms. Participants can expect to be part of a long-term study where their health will be monitored, which will help improve understanding and treatment of this challenging condition. This trial is currently recruiting participants, and anyone interested should consult with a healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• 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:
• • -