An observational study in Chronic Rhinosinusitis (Diagnosis), sponsored by Change Accelerator in Respiratory Care. Recruiting at 13 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Change Accelerator in Respiratory Care · Observational
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.
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.
This is the only study on the registry with Change Accelerator in Respiratory Care as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Users of the Galenus Health mobile application who reported a diagnosis with CRS will be entered into the registry if they provided consent for scientific research. Confirmation of CRS diagnosis by a physician will be performed via the web-based dashboard. The CRS population includes both patients with and without nasal polyps, with and without asthma co-morbidity, with or without former surgery, aged 18 years or above. Patients are included into the registry with the aim of longitudinal follow up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult chronic rhinosinusitis patients capable of using a mobile application.
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
Time frame: 1 year
Symptom severity - facial pain
Baseline and change in VAS facial pain; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - impaired smell
Baseline and change in VAS impaired smell; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - nasal blockage
Baseline and change in VAS nasal blockage; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - nasal secretions
Baseline and change in VAS nasal secretions; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - post-nasal drip
Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - wheeze
Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - dyspnoea
Baseline and change in VAS dyspnoea; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - chest tightness
Baseline and change in VAS chest tightness; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - cough
Baseline and change in VAS cough; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - itchy nose
Baseline and change in VAS itchy nose; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - itchy eyes
Baseline and change in VAS itchy eyes; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Symptom severity - sneeze
Baseline and change in VAS sneeze; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Disease impact - work or school
Baseline and change in VAS work or school; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 1 year
Disease impact - sleep quality
Baseline and change in VAS impact sleep quality; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame: 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
Time frame: 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)
Time frame: Registration at time of event
Medication use
Changes in medication
Time frame: Registration at time of new prescription and intakes
General health-related quality of life
EQ-5D-5L (EuroQol-5Dimension-5Level) questionnaire
Time frame: 1 year
CRS-specific quality of life
SNOT-22 (SinoNasal Outcome Test-22) questionnaire
Time frame: 1 year
Nasal Polyp Score
Baseline and change in nasal polyp score
Time frame: 1 year
Lund-Mackay score
Baseline Lund-Mackay score
Time frame: 1 year
Blood eosinophil counts
cells/mm\^3
Time frame: 1 year
Serum total IgE
IU/ml
Time frame: 1 year
Work Performance and Activity Impairment
Work Performance and Activity Impairment questionnaire
Time frame: 1 year
Hospitalisations
Number of hospitalisation for nose, sinus or lung problem in the past year
Time frame: 1 year
Oral corticosteroid use
Courses of oral corticosteroid in the past year
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Jun 2025, 53 months after the start.
How these figures are worked out, and which studies are left out of them.
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