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ClinicalTrials.gov ID

NCT06970977

Lead Sponsor

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

Overall Status

Recruiting

Study Type

Observational

Enrollment

1,000Estimated

Last Update Posted

Aug 7, 2025Actual

Start Date

Sep 1, 2024Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Sep 30, 2026Estimated

Official Title

CRS Questionnaire Validation Project

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.

Detailed Description

The objectives of this study are as follows:

• Validation of two new questionnaires with the aim of measuring the current perceived condition of a patient with chronic rhinosinusitis in terms of control and severity.
• Validation of these questionnaires in routine medical settings.
• Evaluation of the results of these questionnaires in comparison with other tools currently available.

• Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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)

Observational Model

Case-Control

Time Perspective

Prospective

Lead Sponsor

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

philippe.gevaert@ugent.be

peter.hellings@kuleuven.be+32 16 33 23 40