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Real-Life Chronic Rhinosinusitis Outcome Registry

C

Change Accelerator in Respiratory Care

Status

Enrolling

Conditions

Chronic Rhinosinusitis (Diagnosis)

Study type

Observational

Funder types

Industry

Identifiers

NCT04670172
GHOR001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

4,550 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

4,550 participants in 1 patient group

Chronic rhinosinusitis patients
Description:
Adult chronic rhinosinusitis patients capable of using a mobile application.

Trial contacts and locations

13

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Central trial contact

Sven F Seys, PhD

Data sourced from clinicaltrials.gov

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