NCT04670172

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.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
10 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

4.5 years

First QC Date

November 25, 2020

Last Update Submit

February 11, 2025

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

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

    1 year

Secondary Outcomes (26)

  • Symptom severity - facial pain

    1 year

  • Symptom severity - impaired smell

    1 year

  • Symptom severity - nasal blockage

    1 year

  • Symptom severity - nasal secretions

    1 year

  • Symptom severity - post-nasal drip

    1 year

  • +21 more secondary outcomes

Study Arms (1)

Chronic rhinosinusitis patients

Adult chronic rhinosinusitis patients capable of using a mobile application.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Physician diagnosis of Chronic RhinoSinusitis
  • Capable of using a mobile application on a smartphone

You may not qualify if:

  • Patients with malignancies of the sinonasal cavity
  • Patients with inverted papilloma
  • Patients with unilateral disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Graz University Hospital

Graz, 8036, Austria

RECRUITING

University Hospital Vienna

Vienna, Austria

RECRUITING

UCL Saint-Luc

Brussels, Belgium

RECRUITING

UZ Ghent

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Helsinki University Hospital

Helsinki, Finland

NOT YET RECRUITING

CHU Lille

Lille, France

RECRUITING

Dusseldorf University Clinic

Düsseldorf, 40225, Germany

RECRUITING

Policlinico Umberto I

Rome, Italy

RECRUITING

UMC Amsterdam

Amsterdam, 1105, Netherlands

RECRUITING

Hospital Clinic de Barcelona

Barcelona, Spain

RECRUITING

Prof Claire Hopkins private practice

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sven F Seys, PhD

    Change Accelerator in Respiratory Care

    STUDY DIRECTOR

  • Claus Bachert, MD, PhD

    UZ Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven F Seys, PhD

CONTACT

0032 495 462585sven.seys@galenus.health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 17, 2020

Study Start

January 1, 2021

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

DK(1)ES(1)DE(1)NL(1)FI(1)BE(3)AU(2)GB(1)FR(1)IT(1)