NCT06970977

CRS Questionnaire Validation Project

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: The European Forum for Research and Education in Allergy and Airway Diseases · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2025-05-14
• Last updated: 2025-08-07

Locations

32 sites across 11 countries: United States, Belgium, Canada, Denmark, Germany, Greece, Italy, Netherlands, Romania, South Africa, Spain