Real-Life Chronic Rhinosinusitis Outcome Registry

NCT ID: NCT04670172

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-31

Brief Summary

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An international consortium of leading medical experts in the field of chronic respiratory disease, the research team of Galenus Health and the non-profit organization EUFOREA (European Forum for Research and Education in Allergy and Airway diseases) has been conceived to conduct real-life outcome research. The Galenus Health digital platform consisting of a mobile application for patients and an online dashboard for physicians will be implemented in each of the participating centres. The data will be centralized in a pseudonymized database and will be the basis of the Chronic RhinoSinusitis Outcome Registry.

Detailed Description

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This real-life chronic rhinosinusitis outcome registry aims at longitudinal data collection from patients attending specialist care centres across Europe.

As primary aim it intends to provide new insights on the burden of uncontrolled disease, the impact on health-related quality of life, productivity loss as well as the effect of disease severity and co-morbid disease on these outcome parameters.

In addition this outcome registry intends to identify patients eligible for type 2 targeted biologic therapy, evaluate treatment effectiveness and markers of treatment response.

Beyond that direct and indirect costs for society related to chronic rhinosinusitis and its' treatment will be studied.

Conditions

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Chronic Rhinosinusitis (Diagnosis)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic rhinosinusitis patients

Adult chronic rhinosinusitis patients capable of using a mobile application.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Physician diagnosis of Chronic RhinoSinusitis
* Capable of using a mobile application on a smartphone

Exclusion Criteria

* Patients with malignancies of the sinonasal cavity
* Patients with inverted papilloma
* Patients with unilateral disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Change Accelerator in Respiratory Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sven F Seys, PhD

Role: STUDY_DIRECTOR

Change Accelerator in Respiratory Care

Claus Bachert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Ghent

Locations

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Graz University Hospital

Graz, , Austria

Site Status RECRUITING

University Hospital Vienna

Vienna, , Austria

Site Status RECRUITING

UCL Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

UZ Ghent

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Helsinki University Hospital

Helsinki, , Finland

Site Status NOT_YET_RECRUITING

CHU Lille

Lille, , France

Site Status RECRUITING

Dusseldorf University Clinic

Düsseldorf, , Germany

Site Status RECRUITING

Policlinico Umberto I

Rome, , Italy

Site Status RECRUITING

UMC Amsterdam

Amsterdam, , Netherlands

Site Status RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Prof Claire Hopkins private practice

London, , United Kingdom

Site Status RECRUITING

Countries

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Austria Belgium Denmark Finland France Germany Italy Netherlands Spain United Kingdom

Central Contacts

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Sven F Seys, PhD

Role: CONTACT

0032 495 462585

Facility Contacts

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Peter-Valentin Tomazic, MD, PhD

Role: primary

Sven Schneider, MD

Role: primary

Sophie Bellemont

Role: primary

Lara Derycke, PhD

Role: primary

Leen Cools, MSc

Role: primary

Anette Kjeldsen, MD, PhD

Role: primary

Anu Laulajainen-Hongisto, MD, PhD

Role: primary

Geoffrey Mortuaire, MD

Role: primary

Martin Wagenmann, MD, PhD

Role: primary

Carlo Cavaliere, MD

Role: primary

Sietze Reitsma, MD, PhD

Role: primary

Camilo Rodriguez, MD

Role: primary

Claire Hopkins, MD, PhD

Role: primary

Other Identifiers

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GHOR001

Identifier Type: -

Identifier Source: org_study_id

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