Chronic Rhinosinusitis Questionnaire Validation Project

This study is looking for 1000 people with chronic rhinosinusitis (CRS), with or without nasal polyps, to help validate two new questionnaires. These questionnaires are designed to measure how severe your CRS symptoms are and how well you feel your condition is controlled. By participating, you'll help researchers confirm that these new tools accurately reflect the experiences of people with CRS. The study is being conducted in medical centers across Europe, the USA, and South Africa. We are currently recruiting participants for this study.

Study design
This is an observational study involving 1000 participants. It is not a drug trial but focuses on validating questionnaires.
What's involved
You will complete questionnaires to help validate them. This will occur through study completion, an average of 6 months.
Compensation
Not stated in the trial record.
Follow-up
Your participation will involve measurements through study completion, an average of 6 months.

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NCT06970977

CRS Questionnaire Validation Project

Recruiting
Not specifiedAges 18+Observational
The European Forum for Research and Education in Allergy and Airway Diseases
~1,000 participants
Updated 2025-08-07 on ClinicalTrials.gov

At a glance

Recruiting sites
28 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Validation of a new questionnaire
Measured over Through study completion, an average of 6 months
+1 more outcome measured
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
32 sites across 15 states
Spain14
Belgium2
Germany2
Greece2
Netherlands2
California1
Illinois1
Massachusetts1

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Eligibility criteria

Inclusion

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

Not capable of giving informed consent
No CRS
Recent sinus surgery (within the last three months)
  • Validation of a new questionnaireThrough 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 resultsThrough 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.