Real-Life Chronic Rhinosinusitis Outcome Registry
ConditionChronic Rhinosinusitis (Diagnosis)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChange Accelerator in Respiratory Care
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Physician diagnosis of Chronic RhinoSinusitis
Capable of using a mobile application on a smartphone
Disqualifiers
Patients with malignancies of the sinonasal cavity
Patients with inverted papilloma
Patients with unilateral disease
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
4,550 Participants
are grouped into 1 trial groupGroup A: Chronic rhinosinusitis patients
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
Symptom severity - facial pain
Baseline and change in VAS facial pain; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame
1 year2
Symptom severity - impaired smell
Baseline and change in VAS impaired smell; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame
1 year3
Symptom severity - nasal blockage
Baseline and change in VAS nasal blockage; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame
1 year4
Symptom severity - nasal secretions
Baseline and change in VAS nasal secretions; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov