Real-Life Chronic Rhinosinusitis Outcome Registry

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

Real-Life Chronic Rhinosinusitis Outcome Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04670172
• Other study ID #: GHOR001
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Change Accelerator in Respiratory Care
• Contact: Sven F Seys, PhD
• Phone: 0032 495 462585
• Email: sven.seys[@]galenus.health
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 4550
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Rhinosinusitis
• Sinusitis

Locations

Country	Name	City	State
Austria	Graz University Hospital	Graz
Austria	University Hospital Vienna	Vienna
Belgium	UCL Saint-Luc	Brussels
Belgium	UZ Ghent	Gent
Belgium	UZ Leuven	Leuven
Denmark	Odense University Hospital	Odense
Finland	Helsinki University Hospital	Helsinki
France	CHU Lille	Lille
Germany	Dusseldorf University Clinic	Düsseldorf
Italy	Policlinico Umberto I	Rome
Netherlands	UMC Amsterdam	Amsterdam
Spain	Hospital Clinic de Barcelona	Barcelona
United Kingdom	Prof Claire Hopkins private practice	London

Sponsors (1)

Lead Sponsor	Collaborator
Change Accelerator in Respiratory Care

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Symptom severity - facial pain	Baseline and change in VAS facial pain; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - impaired smell	Baseline and change in VAS impaired smell; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - nasal blockage	Baseline and change in VAS nasal blockage; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - nasal secretions	Baseline and change in VAS nasal secretions; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - post-nasal drip	Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - wheeze	Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - dyspnoea	Baseline and change in VAS dyspnoea; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - chest tightness	Baseline and change in VAS chest tightness; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - cough	Baseline and change in VAS cough; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - itchy nose	Baseline and change in VAS itchy nose; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - itchy eyes	Baseline and change in VAS itchy eyes; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Symptom severity - sneeze	Baseline and change in VAS sneeze; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Disease impact - work or school	Baseline and change in VAS work or school; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	Disease impact - sleep quality	Baseline and change in VAS impact sleep quality; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm	1 year
Secondary	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
Secondary	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
Secondary	Medication use	Changes in medication	Registration at time of new prescription and intakes
Secondary	General health-related quality of life	EQ-5D-5L (EuroQol-5Dimension-5Level) questionnaire	1 year
Secondary	CRS-specific quality of life	SNOT-22 (SinoNasal Outcome Test-22) questionnaire	1 year
Secondary	Nasal Polyp Score	Baseline and change in nasal polyp score	1 year
Secondary	Lund-Mackay score	Baseline Lund-Mackay score	1 year
Secondary	Blood eosinophil counts	cells/mm^3	1 year
Secondary	Serum total IgE	IU/ml	1 year
Secondary	Work Performance and Activity Impairment	Work Performance and Activity Impairment questionnaire	1 year
Secondary	Hospitalisations	Number of hospitalisation for nose, sinus or lung problem in the past year	1 year
Secondary	Oral corticosteroid use	Courses of oral corticosteroid in the past year	1 year