Registry for patients with severe, uncontrolled chronic rhinosinusitis in Italy
Rhinosinusitis Italian Network (RINET): the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
This study is collecting information from patients in Italy with severe chronic rhinosinusitis to see how their condition changes over time and what treatments work best for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Italian Academy of Rhinology Academic / other |
| Locations | 1 site (Rozzano, MIlan) |
| Trial ID | NCT05935683 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect data on patients with uncontrolled chronic rhinosinusitis (CRS) across Italy. Patients will be enrolled through the Rhinosinusitis Italian Network (RINET) and treated by a multidisciplinary team including allergists, otolaryngologists, and pneumologists. The study focuses on characterizing the evolution of CRS, evaluating therapeutic strategies, and identifying biomarkers for treatment response. It also aims to enhance awareness of CRS within the medical community and the public.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of bilateral chronic rhinosinusitis who meet specific clinical criteria indicating severe and uncontrolled symptoms.
Not a fit: Patients with mild or well-controlled chronic rhinosinusitis may not benefit from participation in this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved treatment strategies and better management of chronic rhinosinusitis for patients.
How similar studies have performed: Other studies have shown success in similar approaches to characterizing chronic rhinosinusitis, indicating potential for meaningful insights from this registry.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Rozzano, MIlan
- Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital — Rozzano, MIlan, Italy (Recruiting)
Study contacts
- Study coordinator: Enrico Marco Heffler, MD, PhD
- Email: enrico.heffler@hunimed.eu
- Phone: 02 82241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.