Clinical trial NCT04670172: Real-Life Chronic Rhinosinusitis Outcome Registry
Official title: Real-Life Chronic Rhinosinusitis Outcome Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: Change Accelerator in Respiratory Care
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 4550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom severity total symptoms
timeFrame: 1 year
Secondary outcomes:
measure: Symptom severity - facial pain
timeFrame: 1 year
measure: Symptom severity - impaired smell
timeFrame: 1 year
measure: Symptom severity - nasal blockage
timeFrame: 1 year
measure: Symptom severity - nasal secretions
timeFrame: 1 year
measure: Symptom severity - post-nasal drip
timeFrame: 1 year
measure: Symptom severity - wheeze
timeFrame: 1 year
measure: Symptom severity - dyspnoea
timeFrame: 1 year
measure: Symptom severity - chest tightness
timeFrame: 1 year
measure: Symptom severity - cough
timeFrame: 1 year
measure: Symptom severity - itchy nose
timeFrame: 1 year
measure: Symptom severity - itchy eyes
timeFrame: 1 year
measure: Symptom severity - sneeze
timeFrame: 1 year
measure: Disease impact - work or school
timeFrame: 1 year
measure: Disease impact - sleep quality
timeFrame: 1 year
measure: Disease impact - daily life activities
timeFrame: 1 year
measure: Healthcare utilisation
timeFrame: Registration at time of event
measure: Medication use
timeFrame: Registration at time of new prescription and intakes
measure: General health-related quality of life
timeFrame: 1 year
measure: CRS-specific quality of life
timeFrame: 1 year
measure: Nasal Polyp Score
timeFrame: 1 year
measure: Lund-Mackay score
timeFrame: 1 year
measure: Blood eosinophil counts
timeFrame: 1 year
measure: Serum total IgE
timeFrame: 1 year
measure: Work Performance and Activity Impairment
timeFrame: 1 year
measure: Hospitalisations
timeFrame: 1 year
measure: Oral corticosteroid use
timeFrame: 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Graz University Hospital
city: Vienna
country: Austria
facility: University Hospital Vienna
city: Brussels
country: Belgium
facility: UCL Saint-Luc
city: Gent
country: Belgium
facility: UZ Ghent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Odense
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Lille
country: France
facility: CHU Lille
city: Düsseldorf
country: Germany
facility: Dusseldorf University Clinic
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Amsterdam
country: Netherlands
facility: UMC Amsterdam
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: London
country: United Kingdom
facility: Prof Claire Hopkins private practice
Study officials:
affiliation: Change Accelerator in Respiratory Care
name: Sven F Seys, PhD
role: STUDY_DIRECTOR
affiliation: UZ Ghent
name: Claus Bachert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: