Recruiting
Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis
NCT05427695
Chronic Rhinosinusitis (Diagnosis), Disease
Chicago, Illinois, United States
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Recruiting
NCT Number: NCT04670172
Real-Life Chronic Rhinosinusitis Outcome Registry
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Graz University Hospital, Graz, Austria
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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Symptom severity total symptoms
Time frame: 1 year
Baseline and change in VAS (visual analogue scale) total nasal, sinus, lung symptoms; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
Secondary outcomes
-
Symptom severity - facial pain
Time frame: 1 year
Baseline and change in VAS facial pain; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - impaired smell
Time frame: 1 year
Baseline and change in VAS impaired smell; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - nasal blockage
Time frame: 1 year
Baseline and change in VAS nasal blockage; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - nasal secretions
Time frame: 1 year
Baseline and change in VAS nasal secretions; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - post-nasal drip
Time frame: 1 year
Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - wheeze
Time frame: 1 year
Baseline and change in VAS post-nasal drip; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - dyspnoea
Time frame: 1 year
Baseline and change in VAS dyspnoea; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - chest tightness
Time frame: 1 year
Baseline and change in VAS chest tightness; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - cough
Time frame: 1 year
Baseline and change in VAS cough; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - itchy nose
Time frame: 1 year
Baseline and change in VAS itchy nose; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - itchy eyes
Time frame: 1 year
Baseline and change in VAS itchy eyes; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Symptom severity - sneeze
Time frame: 1 year
Baseline and change in VAS sneeze; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Disease impact - work or school
Time frame: 1 year
Baseline and change in VAS work or school; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Disease impact - sleep quality
Time frame: 1 year
Baseline and change in VAS impact sleep quality; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Disease impact - daily life activities
Time frame: 1 year
Baseline and change in VAS impact daily life activities; 0 (Not at all bothersome) - 100 (Extremely bothersome) mm
-
Healthcare utilisation
Time frame: Registration at time of event
Number of care pathway events (healthcare provider visits, emergency room visits, hospitalisation, CT scan, endoscopic sinus surgery, bronchial thermoplastic, diagnostic tests)
-
Medication use
Time frame: Registration at time of new prescription and intakes
Changes in medication
-
General health-related quality of life
Time frame: 1 year
EQ-5D-5L (EuroQol-5Dimension-5Level) questionnaire
-
CRS-specific quality of life
Time frame: 1 year
SNOT-22 (SinoNasal Outcome Test-22) questionnaire
-
Nasal Polyp Score
Time frame: 1 year
Baseline and change in nasal polyp score
-
Lund-Mackay score
Time frame: 1 year
Baseline Lund-Mackay score
-
Blood eosinophil counts
Time frame: 1 year
cells/mm^3
-
Serum total IgE
Time frame: 1 year
IU/ml
-
Work Performance and Activity Impairment
Time frame: 1 year
Work Performance and Activity Impairment questionnaire
-
Hospitalisations
Time frame: 1 year
Number of hospitalisation for nose, sinus or lung problem in the past year
-
Oral corticosteroid use
Time frame: 1 year
Courses of oral corticosteroid in the past year
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Change Accelerator in Respiratory Care
Industry
Registry information
Important dates
- Study start
- 2021
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Dec 17, 2020
- Registry last updated
- Feb 13, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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