Registry for patients with severe, uncontrolled chronic rhinosinusitis in Italy
Official title: Rhinosinusitis Italian Network (RINET): the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
Run by Italian Academy of Rhinology · NCT05935683 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Italian Academy of Rhinology Academic / other |
| Locations | 1 site (Rozzano, MIlan) |
| Status | Recruiting |
| Started | November 1, 2021 |
| Main results expected | October 31, 2031 |
| Study ends | October 31, 2031 |
| Registry record updated | July 19, 2024 |
| Trial ID | NCT05935683 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with a confirmed diagnosis of bilateral chronic rhinosinusitis who meet specific clinical criteria indicating severe and uncontrolled symptoms.
✕Probably not a fit
Patients with mild or well-controlled chronic rhinosinusitis may not benefit from participation in this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success in similar approaches to characterizing chronic rhinosinusitis, indicating potential for meaningful insights from this registry.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Chinese herbal nasal rinses after sinus surgery
This test sees if daily Chinese herbal nasal rinses for two months help people recovering from FESS for chronic rhinosinusitis compared with normal saline.
-
Triamcinolone-loaded nanocapsules after endoscopic nasal surgery
This trial tests whether a triamcinolone acetonide–loaded nanocapsule spray is better than saline irrigation for healing after endoscopic nasal surgery in adults with chronic rhinosinusitis and nasal polyps.
-
Smell training in CRS patients with smell loss
This study tests whether a 3-month smell training program can improve smell function and related immune and mental health measures in adults with chronic rhinosinusitis and smell loss.
-
PROPEL corticosteroid‑releasing sinus implants — IBUKI cohort
This project tests how safe and well PROPEL corticosteroid‑releasing sinus implants work for people in Japan with chronic rhinosinusitis who undergo endoscopic sinus surgery.
-
Lavender aromatherapy for anxiety and pain during awake ear, nose, and throat procedures
This tests whether lavender aromatherapy used during awake ear, nose, and throat clinic procedures can reduce anxiety and pain in adults.
-
Seawater nasal sprays for relief of nasal and sinus symptoms
This project will test four seawater nasal sprays to see if they help infants, children, adults, and pregnant or breastfeeding people with acute or chronic nasal and sinus symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.