Validation of questionnaires for chronic rhinosinusitis severity and control
Official title: CRS Questionnaire Validation Project
Run by The European Forum for Research and Education in Allergy and Airway Diseases · NCT06970977 · Data updated 2026-11-12
This study is testing two new questionnaires to see if they can help people with chronic rhinosinusitis understand how severe their symptoms are and how well they are managing them.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | The European Forum for Research and Education in Allergy and Airway Diseases Academic / other |
| Locations | 32 sites (Santa Monica, California and 31 other locations) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT06970977 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with chronic rhinosinusitis with or without nasal polyps who can provide informed consent and have not undergone recent sinus surgery.
✕Probably not a fit
Patients who have not been diagnosed with chronic rhinosinusitis or have had sinus surgery within the last three months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project involves a collaboration of 32 medical centers across Europe, the USA, and South Africa to validate two new questionnaires designed to assess the self-perceived severity and control of chronic rhinosinusitis (CRS) with and without nasal polyps. The study aims to recruit 1000 patients from routine ENT practices to ensure a straightforward data collection process. The statistical analysis and report creation will be managed by the University of Leuven's statistical department, comparing the new questionnaires with existing assessment tools.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for patients and clinicians to assess and manage chronic rhinosinusitis more effectively.
How similar studies have gone: Previous studies have successfully validated similar questionnaires for chronic conditions, suggesting a promising outcome for this validation project.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient capable of giving informed consent * Diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines * No recent sinus surgery (within the last three months) Exclusion Criteria: * Not capable of giving informed consent * No CRS * Recent sinus surgery (within the last three months)
Where it's running
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UCLA Santa Monica Medical Center
Santa Monica, California, United States Recruiting -
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States Recruiting -
Brigham Sinus Center at Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States Recruiting -
Eastern Virginia Medical School
Virginia City, Virginia, United States Recruiting -
UZ Leuven
Leuven, Belgium Recruiting
Show 26 more locations
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St. Michael's Hospital
Toronto, Canada Recruiting -
Univ of Copenhagen
Copenhagen, Denmark Recruiting -
University General Hospital of Heraklion
Heraklion, Greece Recruiting -
U. Aristotle
Thessaloniki, Greece Recruiting -
Univ Hospital Roma
Roma, Italy Recruiting -
Alrijne Zorggroep
Leiden, Netherlands Recruiting -
University of Oradea
Oradea, Romania Recruiting -
Ahmed Alkhadi Hospital
Durban, South Africa Recruiting -
Hospital Clínico Universitario de Compostela
A Coruña, Spain Recruiting -
Hospital Clinic Barcelona
Barcelona, Spain Recruiting -
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain Recruiting -
Hospital de La Línea de La Concepción
Cadiz, Spain Recruiting -
Hospital Universitario Jerez de La Frontera
Cadiz, Spain Recruiting -
Hospital Universitario Puerta del Mar
Cadiz, Spain Recruiting -
Hospital Universitario Puerto Real
Cadiz, Spain Recruiting -
Hospital Universitario Fuenlabrada
Madrid, Spain Recruiting -
Hospital Universitario Infanta Elena, Madrid y Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain Recruiting -
Hospital Universitario Ramón y Cajal
Madrid, Spain Recruiting -
Hospital del Bierzo
Ponferrada, Spain Recruiting -
Hospital Universitario Marqués de Valdecilla
Santander, Spain Recruiting -
Hospital Universitario Virgen Macarena
Seville, Spain Recruiting -
Hospital General Universitario de Valencia
Valencia, Spain Recruiting -
UZ Gent
Ghent, Belgium Not yet recruiting -
HNO-Klinik, Universitätsklinikum Düsseldorf
Düsseldorf, Germany Not yet recruiting -
Univ Munich
Munich, Germany Not yet recruiting -
Univ Amsterdam
Amsterdam, Netherlands Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Airiver Balloon Dilation added to endoscopic sinus surgery for chronic rhinosinusitis with or without nasal polyps
This study tests whether adding a paclitaxel-coated balloon dilation to endoscopic sinus surgery helps adults with chronic rhinosinusitis, with or without nasal polyps, at up to 40 US sites.
-
Sinonasal microbiome transplant for chronic rhinosinusitis
This will try a sinonasal microbiome transplant to see if it reduces symptoms in people with chronic rhinosinusitis with or without nasal polyps.
-
OPN-375 (fluticasone) nasal spray twice daily for teens with chronic rhinosinusitis without nasal polyps
This study will test whether OPN-375 nasal spray (186 µg) given twice daily helps adolescents (12–17) with chronic rhinosinusitis without nasal polyps have fewer symptoms than placebo.
-
Investigating the effects of Dupilumab on nasal barrier function in chronic rhinosinusitis patients
This study is testing if the medication Dupilumab can improve the nasal barrier function in people with chronic rhinosinusitis, especially those with nasal polyps.
-
Using 3D printing to enhance nasal irrigation for chronic rhinosinusitis
This study is testing if 3D printed models of patients' noses can help people with chronic rhinosinusitis use nasal irrigation more effectively and feel better without surgery.
-
Mepolizumab with or without in-office nasal polypectomy for chronic rhinosinusitis with nasal polyps
This study tests whether adding mepolizumab, alone or with in-office nasal polypectomy, helps adults with chronic rhinosinusitis with nasal polyps who need biologic treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.