CRS Questionnaire Validation Project

August 6, 2025 updated by: The European Forum for Research and Education in Allergy and Airway Diseases

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
  • Canada
      • Toronto, Canada
  • Denmark
      • Copenhagen, Denmark
  • Germany
      • Düsseldorf, Germany
        • Not yet recruiting
        • HNO-Klinik, Universitätsklinikum Düsseldorf
        • Contact:
      • Munich, Germany
  • Greece
      • Iraklio, Greece
        • Recruiting
        • University General Hospital of Heraklion
        • Contact:
      • Thessaloniki, Greece
  • Italy
  • Netherlands
  • Romania
  • South Africa
  • Spain
      • Barcelona, Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
      • Cadiz, Spain
        • Recruiting
        • Hospital Universitario Puerto Real
        • Contact:
      • Cadiz, Spain
        • Recruiting
        • Hospital Universitario Puerta Del Mar
        • Contact:
      • Cadiz, Spain
        • Recruiting
        • Hospital Universitario Jerez de la Frontera
        • Contact:
      • Cádiz, Spain
        • Recruiting
        • Hospital de la Línea de la Concepción
        • Contact:
      • La Coruña, Spain
      • Madrid, Spain
      • Madrid, Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Infanta Elena, Madrid y Hospital Universitario Fundación Jiménez Díaz
        • Contact:
      • Ponferrada, Spain
      • Santander, Spain
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
      • Valencia, Spain
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:
  • United States
    • California
      • Santa Monica, California, United States, 90401
        • Recruiting
        • UCLA Santa Monica Medical Center
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60208
        • Recruiting
        • Northwestern University Feinberg School of Medicine
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham Sinus Center at Brigham and Women's Hospital
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
    • Virginia
      • Virginia, Virginia, United States, 23507
        • Recruiting
        • Eastern Virginia Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients, capable of giving consent, with certified CRS and no recent sinus surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

May 6, 2025

First Posted (Actual)

May 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S68027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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