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RecruitingNCT05935683RINETUpdated Jul 19, 2024

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

An observational study in Chronic Rhinosinusitis, sponsored by Italian Academy of Rhinology. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by Italian Academy of Rhinology · Observational

From the registry’s dates

  • Started Nov 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.
02

Conditions studied

  • Chronic Rhinosinusitis

Keywords

  • chronic rhinosinusitis with nasal polyps
  • chronic rhinosinusitis without nasal polyps
  • Otorhinolaryngologic Diseases
  • Respiratory Tract Diseases
  • Paranasal Sinus Diseases
  • Sinusitis
  • Nose Diseases
  • chronic rhinosinusitis (diagnosis)
03

In context

Otorhinolaryngologic Diseases

54 studies on the registry are indexed under Otorhinolaryngologic Diseases; 9 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 398 across 12 observational studies indexed under Otorhinolaryngologic Diseases.

Browse Otorhinolaryngologic Diseases studies →

Lead sponsor

This is the only study on the registry with Italian Academy of Rhinology as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Severe, Uncontrolled Chronic Rhinosinusitis with or without nasal polyps according to the European Position Paper on Rhinosinusitis and Nasal Polyps - EPOS2020 and to the EUFOREA consensus on biologics for CRSwNP with or without asthma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Interventions

  • OtherSevere Uncontrolled Chronic Rhinosinusitis patients (CRS)

    Obsertvation

    Also known as: Adult chronic rhinosinusitis patients.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Every year to ten year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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 on biologics for CRSwNP with or without asthma. Allergy. 2019 Dec;74(12):2312-2319. doi: 10.1111/all.13875. Epub 2019 Jul 15. PubMed 31090937 ↗
  • 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, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600. PubMed 32077450 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05935683
Lead sponsor
Italian Academy of Rhinology
Collaborators
Accademia Italiana di Citologia Nasale
Responsible party
Sponsor
First posted
Jul 7, 2023
Start date
Nov 1, 2021
Primary completion
Oct 31, 2031 (estimated)
Completion
Oct 31, 2031 (estimated)
Last update
Jul 19, 2024

Study contacts

Enrico Marco Heffler, MD, PhD
Contact
enrico.heffler@hunimed.eu
02 82241 ext. +39
Concetta Sirena, Dr.
Contact
concetta.sirena@infomed-online.it
342 0790871 ext. +39
Enrico Marco Heffler, MD, PhD
study chair · Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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