Real-Life Chronic Rhinosinusitis Outcome Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Real-Life Chronic Rhinosinusitis Outcome Registry

Conditions
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Chronic Rhinosinusitis (Diagnosis)

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic rhinosinusitis patients<br>Adult chronic rhinosinusitis patients capable of using a mobile application. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity total symptoms | Baseline and change in VAS (visual analogue scale) total nasal, sinus, lung symptoms; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity - facial pain | Baseline and change in VAS facial pain; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - impaired smell | Baseline and change in VAS impaired smell; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - nasal blockage | Baseline and change in VAS nasal blockage; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - nasal secretions | Baseline and change in VAS nasal secretions; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - post-nasal drip | Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - wheeze | Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - dyspnoea | Baseline and change in VAS dyspnoea; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - chest tightness | Baseline and change in VAS chest tightness; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - cough | Baseline and change in VAS cough; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - itchy nose | Baseline and change in VAS itchy nose; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - itchy eyes | Baseline and change in VAS itchy eyes; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Symptom severity - sneeze | Baseline and change in VAS sneeze; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Disease impact - work or school | Baseline and change in VAS work or school; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Disease impact - sleep quality | Baseline and change in VAS impact sleep quality; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Disease impact - daily life activities | Baseline and change in VAS impact daily life activities; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm | 1 year | 
| Healthcare utilisation | Number of care pathway events (healthcare provider visits, emergency room visits, hospitalisation, CT scan, endoscopic sinus surgery, bronchial thermoplastic, diagnostic tests) | Registration at time of event | 
| Medication use | Changes in medication | Registration at time of new prescription and intakes | 
| General health-related quality of life | EQ-5D-5L (EuroQol-5Dimension-5Level) questionnaire | 1 year | 
| CRS-specific quality of life | SNOT-22 (SinoNasal Outcome Test-22) questionnaire | 1 year | 
| Nasal Polyp Score | Baseline and change in nasal polyp score | 1 year | 
| Lund-Mackay score | Baseline Lund-Mackay score | 1 year | 
| Blood eosinophil counts | cells/mm^3 | 1 year | 
| Serum total IgE | IU/ml | 1 year | 
| Work Performance and Activity Impairment | Work Performance and Activity Impairment questionnaire | 1 year | 
| Hospitalisations | Number of hospitalisation for nose, sinus or lung problem in the past year | 1 year | 
| Oral corticosteroid use | Courses of oral corticosteroid in the past year | 1 year |