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Chronic Rhinosinusitis (Diagnosis)NCT04670172

Real-Life Chronic Rhinosinusitis Outcome Registry

An observational study of Chronic Rhinosinusitis (Diagnosis), run by Change Accelerator in Respiratory Care at 13 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Rhinosinusitis (Diagnosis)
How many people
4,550 participants
Where
13 sitesin 10 countries
Study dates
1 Jan 2021to 31 Dec 2025
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

13 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Sven F Seys, PhD contact

0032 495 462585

sven.seys@galenus.health

13 sites in 10 countries

Belgium3 sites, 3 recruiting

  • UCL Saint-Luc

    Brussels

    Sophie Bellemont

    Valérie Hox, MD, PhD

    Recruiting

  • UZ Ghent

    Ghent, 9000

    Lara Derycke, PhD, lara.derycke@ugent.be

    Claus Bachert, MD, PhD

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Leen Cools, MSc, leen.cools@uzleuven.be

    Peter W Hellings, MD, PhD

    Recruiting

Other trials in Belgium

Austria2 sites, 2 recruiting

  • Graz University Hospital

    Graz, 8036

    Peter-Valentin Tomazic, MD, PhD

    Peter-Valentin Tomazic, MD, PhD

    Recruiting

  • University Hospital Vienna

    Vienna

    Sven Schneider, MD

    Sven Schneider, MD

    Recruiting

Other trials in Austria

Denmark1 site, 1 recruiting

  • Odense University Hospital

    Odense, 5000

    Anette Kjeldsen, MD, PhD

    Anette Kjeldsen, MD, PhD

    Recruiting

Other trials in Denmark

Finland1 site, 1 recruiting

  • Helsinki University Hospital

    Helsinki

    Anu Laulajainen-Hongisto, MD, PhD

    Anu Laualjainen-Hongisto, MD, PhD

    Not yet recruiting

Other trials in Finland

France1 site, 1 recruiting

  • CHU Lille

    Lille

    Geoffrey Mortuaire, MD

    Geoffrey Mortuaire, MD

    Recruiting

Other trials in France

Germany1 site, 1 recruiting

  • Dusseldorf University Clinic

    Düsseldorf, 40225

    Martin Wagenmann, MD, PhD

    Martin Wagenmann, MD, PhD

    Recruiting

Other trials in Germany

Italy1 site, 1 recruiting

  • Policlinico Umberto I

    Rome

    Carlo Cavaliere, MD

    Antonio Greco, MD, PhD

    Recruiting

Other trials in Italy

Netherlands1 site, 1 recruiting

  • UMC Amsterdam

    Amsterdam, 1105

    Sietze Reitsma, MD, PhD

    Sietze Reitsma, MD, PhD

    Recruiting

Other trials in Netherlands

Spain1 site, 1 recruiting

  • Hospital Clinic de Barcelona

    Barcelona

    Camilo Rodriguez, MD

    Isam Alobid, MD

    Recruiting

Other trials in Spain

United Kingdom1 site, 1 recruiting

  • Prof Claire Hopkins private practice

    London

    Claire Hopkins, MD, PhD

    Claire Hopkins, MD, PhD

    Recruiting

Other trials in United Kingdom

About this study

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.

Read the 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.

Medical subject headings
Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04670172
Study groupRoleWhat they receive
Chronic rhinosinusitis patientsAdult chronic rhinosinusitis patients capable of using a mobile application.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (26)

  1. Symptom severity - facial pain

    Baseline and change in VAS facial pain; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  2. Symptom severity - impaired smell

    Baseline and change in VAS impaired smell; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  3. Symptom severity - nasal blockage

    Baseline and change in VAS nasal blockage; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  4. Symptom severity - nasal secretions

    Baseline and change in VAS nasal secretions; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  5. Symptom severity - post-nasal drip

    Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  6. Symptom severity - wheeze

    Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  7. Symptom severity - dyspnoea

    Baseline and change in VAS dyspnoea; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  8. Symptom severity - chest tightness

    Baseline and change in VAS chest tightness; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  9. Symptom severity - cough

    Baseline and change in VAS cough; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  10. Symptom severity - itchy nose

    Baseline and change in VAS itchy nose; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  11. Symptom severity - itchy eyes

    Baseline and change in VAS itchy eyes; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  12. Symptom severity - sneeze

    Baseline and change in VAS sneeze; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  13. Disease impact - work or school

    Baseline and change in VAS work or school; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  14. Disease impact - sleep quality

    Baseline and change in VAS impact sleep quality; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  15. Disease impact - daily life activities

    Baseline and change in VAS impact daily life activities; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm

    Measured: 1 year

  16. Healthcare utilisation

    Number of care pathway events (healthcare provider visits, emergency room visits, hospitalisation, CT scan, endoscopic sinus surgery, bronchial thermoplastic, diagnostic tests)

    Measured: Registration at time of event

  17. Medication use

    Changes in medication

    Measured: Registration at time of new prescription and intakes

  18. General health-related quality of life

    EQ-5D-5L (EuroQol-5Dimension-5Level) questionnaire

    Measured: 1 year

  19. CRS-specific quality of life

    SNOT-22 (SinoNasal Outcome Test-22) questionnaire

    Measured: 1 year

  20. Nasal Polyp Score

    Baseline and change in nasal polyp score

    Measured: 1 year

  21. Lund-Mackay score

    Baseline Lund-Mackay score

    Measured: 1 year

  22. Blood eosinophil counts

    cells/mm^3

    Measured: 1 year

  23. Serum total IgE

    IU/ml

    Measured: 1 year

  24. Work Performance and Activity Impairment

    Work Performance and Activity Impairment questionnaire

    Measured: 1 year

  25. Hospitalisations

    Number of hospitalisation for nose, sinus or lung problem in the past year

    Measured: 1 year

  26. Oral corticosteroid use

    Courses of oral corticosteroid in the past year

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start1 Jan 2021
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,550 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670172
Sponsor's protocol ID
GHOR001
Status last verified
Feb 2025
First submitted
25 Nov 2020
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Rhinosinusitis (Diagnosis), run by Change Accelerator in Respiratory Care at 13 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Belgium, Austria, Denmark, Finland, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sven F Seys, PhD (0032 495 462585, sven.seys@galenus.health), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom severity total symptoms (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04670172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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