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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorItalian Academy of Rhinology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)

    Other intervention

    Obsertvation

Treatment groups

No treatment groups listed

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Italian Academy of Rhinology

Lead sponsor

Accademia Italiana di Citologia Nasale

Collaborator