NCT04670172

Real-Life Chronic Rhinosinusitis Outcome Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,550 (estimated)
• Sponsor: Change Accelerator in Respiratory Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Chronic Rhinosinusitis (Diagnosis)

Timeline

• Start date: 2021-01-01
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2020-12-17
• Last updated: 2025-02-13

Locations

13 sites across 10 countries: Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, United Kingdom