Recruiting

Observational Study

Sponsor:

The European Forum for Research and Education in Allergy and Airway Diseases

Code:

NCT06970977

Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The 'CRS validation project' consists of a joint effort of 32 medical centers in Europe, the USA, and South Africa to carry out the validation of 2 novel questionnaires designated to measure self-perceived severity and control of Chronic Rhinosinusitis (with or without nasal polyps).

This study will validate translated versions of the same set of questionnaires simultaneously in the centers involved after recruiting a total of 1000 patients, while data collection, statistical analysis, and creation of the study report will be carried out by the statistical department of the University of Leuven.

Patients will be recruited from the regular ENT practice of their hospital to minimize the complexity of the study.

Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Study ID

NCT06970977

Start date

Sep 1, 2024

Status verified date

Aug, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Validation of a new questionnaire [ Time Frame: Through study completion, an average of 6 months ]
  • Evaluation of the results [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts and Locations

Locations

UCLA Santa Monica Medical Center

Recruiting

Santa Monica, California, United States, 90401

Contacts

Jivianne Lee

+1 310-825-9111JTLee@mednet.ucla.edu

Northwestern University Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60208

Contacts

Anju Peters

+1 312-503-8194anjupeters@northwestern.edu

Brigham Sinus Center at Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Stella Lee

+1(617) 525-6500slee192@bwh.harvard.edu

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Elina Toskala

+1 215-955-6000Elina.Toskala@jefferson.edu

Eastern Virginia Medical School

Recruiting

Virginia City, Virginia, United States, 23507

Contacts

Joseph Han

+1 757-446-5600hanjk@evms.edu

St. Michael's Hospital

Recruiting

Toronto, Canada

Contacts

Yvonne Chan

y.chan@utoronto.ca

More Information

Sponsor

The European Forum for Research and Education in Allergy and Airway Diseases

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The European Forum for Research and Education in Allergy and Airway Diseases on 2025-08-07.