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

Chronic Rhinosinusitis Clinical Trial

— RINET  

Official title:

Rhinosinusitis Italian Network (RINET): the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935683
• Other study ID #: 2876
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: October 31, 2031

Study information

• Verified date: December 2023
• Source: Italian Academy of Rhinology
• Contact: Enrico Marco Heffler, MD, PhD
• Phone: 02 82241
• Email: enrico.heffler[@]hunimed.eu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

The primary objectives of the study are: - to characterize and to describe the evolution of uncontrolled Chronic Rhinosinusitis (CRS); - to facilitate and to characterize the phenotyping and endotyping of CRS; - studying the efficacy and safety of the principal therapeutic strategies and approaches to uncontrolled CRS in real-life; - supporting the development of diagnostic methodologies and innovative therapeutic strategies for CRS; - to evaluate the clinical and economic-health impact of the different therapeutic approaches (including systemic corticosteroids) used for uncontrolled CRS; - to describe factors associated with therapeutic choices and how much this factors influence natural history of the CRS; - Studying and identifying biomarkers and predictors of response to different therapies; - to increase the "awareness" of CRS in patients, in public opinion, in the national and international scientific community, and in the Italian clinical community of the otolaryngologists, the allergists and the pneumologists.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: October 31, 2031
• Est. primary completion date: October 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Intervention

Other:
• Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)
Obsertvation

Locations

Country	Name	City	State
Italy	Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital	Rozzano	MIlan

Sponsors (2)

Lead Sponsor	Collaborator
Italian Academy of Rhinology	Accademia Italiana di Citologia Nasale

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Fokkens WJ, Lund V, Bachert C, Mullol J, Bjermer L, Bousquet J, Canonica GW, Deneyer L, Desrosiers M, Diamant Z, Han J, Heffler E, Hopkins C, Jankowski R, Joos G, Knill A, Lee J, Lee SE, Marien G, Pugin B, Senior B, Seys SF, Hellings PW. EUFOREA consensus — View Citation

Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diama — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Polyp Score	Change from baseline in total Nasal Polyp Score at year 1 to ten. The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy.	Every year to ten year

External Links

•   Description Rhinosinusitis Italian NETwork