Real-Life Chronic Rhinosinusitis Outcome Registry
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Registration Number
- NCT04670172
- Lead Sponsor
- Change Accelerator in Respiratory Care
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4550
- Physician diagnosis of Chronic RhinoSinusitis
- Capable of using a mobile application on a smartphone
- Patients with malignancies of the sinonasal cavity
- Patients with inverted papilloma
- Patients with unilateral disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptom severity total symptoms 1 year Baseline and change in VAS (visual analogue scale) total nasal, sinus, lung symptoms; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
- Secondary Outcome Measures
Name Time Method Symptom severity - facial pain 1 year Baseline and change in VAS facial pain; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Symptom severity - wheeze 1 year Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Blood eosinophil counts 1 year cells/mm\^3
Symptom severity - itchy eyes 1 year Baseline and change in VAS itchy eyes; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Medication use Registration at time of new prescription and intakes Changes in medication
Symptom severity - post-nasal drip 1 year Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Symptom severity - chest tightness 1 year Baseline and change in VAS chest tightness; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Symptom severity - impaired smell 1 year Baseline and change in VAS impaired smell; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Symptom severity - nasal secretions 1 year Baseline and change in VAS nasal secretions; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Symptom severity - dyspnoea 1 year Baseline and change in VAS dyspnoea; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Symptom severity - sneeze 1 year Baseline and change in VAS sneeze; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
General health-related quality of life 1 year EQ-5D-5L (EuroQol-5Dimension-5Level) questionnaire
CRS-specific quality of life 1 year SNOT-22 (SinoNasal Outcome Test-22) questionnaire
Symptom severity - nasal blockage 1 year Baseline and change in VAS nasal blockage; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Symptom severity - cough 1 year Baseline and change in VAS cough; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Disease impact - daily life activities 1 year Baseline and change in VAS impact daily life activities; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Healthcare utilisation Registration at time of event Number of care pathway events (healthcare provider visits, emergency room visits, hospitalisation, CT scan, endoscopic sinus surgery, bronchial thermoplastic, diagnostic tests)
Nasal Polyp Score 1 year Baseline and change in nasal polyp score
Lund-Mackay score 1 year Baseline Lund-Mackay score
Hospitalisations 1 year Number of hospitalisation for nose, sinus or lung problem in the past year
Symptom severity - itchy nose 1 year Baseline and change in VAS itchy nose; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Disease impact - work or school 1 year Baseline and change in VAS work or school; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Disease impact - sleep quality 1 year Baseline and change in VAS impact sleep quality; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Serum total IgE 1 year IU/ml
Work Performance and Activity Impairment 1 year Work Performance and Activity Impairment questionnaire
Oral corticosteroid use 1 year Courses of oral corticosteroid in the past year
Trial Locations
- Locations (13)
Graz University Hospital
🇦🇹Graz, Austria
University Hospital Vienna
🇦🇹Vienna, Austria
UCL Saint-Luc
🇧🇪Brussels, Belgium
UZ Ghent
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Odense University Hospital
🇩🇰Odense, Denmark
Helsinki University Hospital
🇫🇮Helsinki, Finland
CHU Lille
🇫🇷Lille, France
Dusseldorf University Clinic
🇩🇪Düsseldorf, Germany
Policlinico Umberto I
🇮🇹Rome, Italy
UMC Amsterdam
🇳🇱Amsterdam, Netherlands
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Prof Claire Hopkins private practice
🇬🇧London, United Kingdom