Actively Recruiting

Age: 18Years +
All Genders
ID04670172

Real-Life Chronic Rhinosinusitis Outcome Registry

Led by Change Accelerator in Respiratory Care · Updated on 2025-02-13

4550

Participants Needed

13

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting an observational study to collect long-term data from adults diagnosed with chronic rhinosinusitis who attend specialist care centers across Europe. The study aims to better understand the burden of uncontrolled disease, its impact on quality of life and productivity, and how disease severity and related conditions affect these outcomes. It also seeks to identify patients who may benefit from type 2 targeted biologic therapy and to evaluate treatment effectiveness and response markers, as well as to study the societal costs related to chronic rhinosinusitis and its treatment. Participants will use the Galenus Health digital platform, which includes a mobile app for patients and an online dashboard for physicians, to provide data in real-life settings. This data will be centralized in a pseudonymized database forming the Chronic RhinoSinusitis Outcome Registry. The study involves ongoing registration of symptoms, healthcare use, medication intake, and disease severity over time. Participants will be monitored through regular assessments of symptom severity, including facial pain, impaired smell, nasal blockage, and other related symptoms, as well as quality of life measures and healthcare utilization. Data on blood eosinophil counts, serum IgE, nasal polyp scores, and imaging scores will also be collected. The primary outcome is symptom severity over one year, with multiple secondary outcomes covering disease impact, work and school productivity, hospitalizations, and medication use. The total participation length varies by individual involvement and follow-up.

CONDITIONS

Brief Title

Real-Life Chronic Rhinosinusitis Outcome Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Physician diagnosis of Chronic RhinoSinusitis
  • Capable of using a mobile application on a smartphone
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Patients with malignancies of the sinonasal cavity
  • Patients with inverted papilloma
  • Patients with unilateral disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 1 year

Participants are observed over time to collect longitudinal data on chronic rhinosinusitis symptoms, disease impact, and healthcare utilization.

Regular assessments via mobile application and clinical visits as needed

Trial Site Locations

Total: 13 locations

1

Graz University Hospital

Graz, Austria, 8036

Actively Recruiting

2

University Hospital Vienna

Vienna, Austria

Actively Recruiting

3

UCL Saint-Luc

Brussels, Belgium

Actively Recruiting

4

UZ Ghent

Ghent, Belgium, 9000

Actively Recruiting

5

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

6

Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

7

Helsinki University Hospital

Helsinki, Finland

Not Yet Recruiting

8

CHU Lille

Lille, France

Actively Recruiting

9

Dusseldorf University Clinic

Düsseldorf, Germany, 40225

Actively Recruiting

10

Policlinico Umberto I

Rome, Italy

Actively Recruiting

11

UMC Amsterdam

Amsterdam, Netherlands, 1105

Actively Recruiting

12

Hospital Clinic de Barcelona

Barcelona, Spain

Actively Recruiting

13

Prof Claire Hopkins private practice

London, United Kingdom

Actively Recruiting

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Research Team

S

Sven F Seys, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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