Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Physician diagnosis of Chronic RhinoSinusitis
- Capable of using a mobile application on a smartphone
- Age 18 years or older
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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