CRS Questionnaire Validation Project

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.

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Key information

Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Gent, Ghent, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Validation of a new questionnaire

Time frame: Through study completion, an average of 6 months

Validation of a questionnaire based on similar questionnaires already approved for use in other airway diseases. The aim to measure the current perceived status of a patient with chronic rhinosinusitis in terms of control and severity.

A new questionnaire will be tested and compared with current tools. For this purpose, a set of questionnaires has been developed including the EPOS criteria for chronic rhinosinusitis, the SNOT-22, the patient global assessment tool and the VAS scores, among others.

All these questionnaires will be completed by the patient at visit 1 and the results will be analysed once the recruitment target of 1,000 patients has been reached.

No second patient participation is required.
Evaluation of the results

Time frame: Through study completion, an average of 6 months

Evaluation of the results of this questionnaire in comparison with other tools currently available.

Once the target of recruiting 1000 patients has been reached, the results will be statistically analysed.

Parallels will be drawn between the responses obtained by the usual means and those captured in the questionnaires to be validated.

It is expected that, in all cases, the degree of control and severity represented in the questionnaires to be validated will conform to the EPOS criteria and to the results of the questionnaires usually used.

The results will be compared for each of the new questionnaires in general and separately by language.

The ultimate goal is to validate what will become the diagnostic gold standard for chronic rhinosinusitis.

Secondary outcomes

Validation of a new questionnaire

Time frame: Through study completion, an average of 6 months

Validation of a questionnaire based on feedback collected from patients with CRS where they expressed which are the symptoms that most afflict them or are most present, related to their disease. The aim to measure the current perceived status of a patient with chronic rhinosinusitis in terms of control and severity.

A new questionnaire will be tested and compared with current tools. For this purpose, a set of questionnaires has been developed including the EPOS criteria for chronic rhinosinusitis, the SNOT-22, the patient global assessment tool and the VAS scores, among others.

All these questionnaires will be completed by the patient at visit 1 and the results will be analysed once the recruitment target of 1,000 patients has been reached.

No second patient participation is required.
Evaluation of the results

Time frame: Through study completion, an average of 6 months

Evaluation of the results of this questionnaire in comparison with other tools currently available.

Once the target of recruiting 1000 patients has been reached, the results will be statistically analysed.

Parallels will be drawn between the responses obtained by the usual means and those captured in the questionnaires to be validated.

It is expected that, in all cases, the degree of control and severity represented in the questionnaires to be validated will conform to the EPOS criteria and to the results of the questionnaires usually used.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: May 14, 2025
Registry last updated: Aug 7, 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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