NCT05935683

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
67mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Nov 2021Oct 2031

Study Start

First participant enrolled

November 1, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2031

Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

10 years

First QC Date

June 29, 2023

Last Update Submit

July 18, 2024

Conditions

Chronic Rhinosinusitis

Keywords

chronic rhinosinusitis with nasal polypschronic rhinosinusitis without nasal polypsOtorhinolaryngologic DiseasesRespiratory Tract DiseasesParanasal Sinus DiseasesSinusitisNose Diseaseschronic rhinosinusitis (diagnosis)

Outcome Measures

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.

    Every year to ten year

Interventions

Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)OTHER

Obsertvation

Also known as: Adult chronic rhinosinusitis patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital

Rozzano, MIlan, 20089, Italy

RECRUITING

Related 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 on biologics for CRSwNP with or without asthma. Allergy. 2019 Dec;74(12):2312-2319. doi: 10.1111/all.13875. Epub 2019 Jul 15.

    PMID: 31090937BACKGROUND

  • 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.

    PMID: 32077450BACKGROUND

Related Links

MeSH Terms

Conditions

Otorhinolaryngologic DiseasesRespiratory Tract DiseasesParanasal Sinus DiseasesSinusitisNose DiseasesDisease

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Enrico Marco Heffler, MD, PhD

    Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy

    STUDY CHAIR

Central Study Contacts

Enrico Marco Heffler, MD, PhD

CONTACT

02 82241enrico.heffler@hunimed.eu

Concetta Sirena, Dr.

CONTACT

342 0790871concetta.sirena@infomed-online.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 7, 2023

Study Start

November 1, 2021

Primary Completion (Estimated)

October 31, 2031

Study Completion (Estimated)

October 31, 2031

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations

IT(1)