Chronic Rhinosinusitis (CRS) With and Without Nasal PolypsNCT06970977
CRS Questionnaire Validation Project
An observational study of Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, run by The European Forum for Research and Education in Allergy and Airway Diseases at 32 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
- How many people
- 1,000 participants
- Where
- 32 sitesin 11 countries
- Study dates
- 1 Sep 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, capable of giving consent, with certified CRS and no recent sinus surgery
Who may be able to join
- 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)
Who cannot join
- Not capable of giving informed consent
- No CRS
- Recent sinus surgery (within the last three months)
Trial locations and contacts
32 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 11 countries
Spain14 sites, 14 recruiting
- Recruiting
Hospital Clínico Universitario de Compostela
A Coruña
Christian Calvo Henriquez, christian.calvo.henriquez@gmail.com
- Recruiting
Hospital Clinic Barcelona
Barcelona
Isam Alobid, isamalobid@gmail.com
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Juan Ramon Gras Cabrerizo, JGras@santpau.cat
- Recruiting
Hospital de La Línea de La Concepción
Cadiz
Eduardo Correa, ecorreaorl@gmail.com
- Recruiting
Hospital Universitario Jerez de La Frontera
Cadiz
Alfonso Del Cuvillo Bernal, dr.cuvillo@gmail.com
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz
Andrés Caballero García, handdres@gmail.com
- Recruiting
Hospital Universitario Puerto Real
Cadiz
Carlos Almagro Ordoñez, Almagro.86@hotmail.com
- Recruiting
Hospital Universitario Fuenlabrada
Madrid
Ithzel María Villareal, imvillarrealp@gmail.com
- Recruiting
Hospital Universitario Infanta Elena, Madrid y Hospital Universitario Fundación Jiménez Díaz
Madrid
Alvaro Sanchez Barrueco, alvaro.sanchez@quironsalud.es
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Alfonso Santamaría Gadea, asantamariagadea@gmail.com
- Recruiting
Hospital del Bierzo
Ponferrada
Xenia Mota, mota.xenia@gmail.com
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander
David Lobo Duro, dlobo28@gmail.com
- Recruiting
Hospital Universitario Virgen Macarena
Seville
Ramón Moreno Luna, ramoluorl@gmail.com
- Recruiting
Hospital General Universitario de Valencia
Valencia
Ainhoa García Lliberós de Miguel, ainhoa.glliberos@gmail.com
United States5 sites, 5 recruiting
- Recruiting
Brigham Sinus Center at Brigham and Women's Hospital
Boston, Massachusetts, 02115
Stella Lee, +1(617) 525-6500, slee192@bwh.harvard.edu
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60208
Anju Peters, +1 312-503-8194, anjupeters@northwestern.edu
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Elina Toskala, +1 215-955-6000, Elina.Toskala@jefferson.edu
- Recruiting
UCLA Santa Monica Medical Center
Santa Monica, California, 90401
Jivianne Lee, +1 310-825-9111, JTLee@mednet.ucla.edu
- Recruiting
Eastern Virginia Medical School
Virginia City, Virginia, 23507
Joseph Han, +1 757-446-5600, hanjk@evms.edu
Belgium2 sites, 2 recruiting
- Not yet recruiting
UZ Gent
Ghent
Philippe Gevaert, philippe.gevaert@ugent.be
- Recruiting
UZ Leuven
Leuven
Peter Hellings, +32 16 33 23 40, peter.hellings@kuleuven.be
Diego Conti, diego.conti@kuleuven.be
Germany2 sites, 2 recruiting
- Not yet recruiting
HNO-Klinik, Universitätsklinikum Düsseldorf
Düsseldorf
Martin Wagenmann, martin.wagenmann@hhu.de
- Not yet recruiting
Univ Munich
Munich
Adam Chaker, adam.chaker@tum.de
Greece2 sites, 2 recruiting
- Recruiting
University General Hospital of Heraklion
Heraklion
Emmanuel Prokopakis, eprokopakis@gmail.com
- Recruiting
U. Aristotle
Thessaloniki
Ioannis Konstantinidis, janconst@otenet.gr
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Univ Amsterdam
Amsterdam
Wytske Fokkens, w.j.fokkens@amsterdamumc.nl
- Recruiting
Alrijne Zorggroep
Leiden
Marjolein Cornet, mecornet@alrijne.nl
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto
Yvonne Chan, y.chan@utoronto.ca
Denmark1 site, 1 recruiting
- Recruiting
Univ of Copenhagen
Copenhagen
Vibeke Backer, backer@dadlnet.dk
Italy1 site, 1 recruiting
- Recruiting
Univ Hospital Roma
Roma
Eugenio De Corso, eugenio.decorso@policlinicogemelli.it
Romania1 site, 1 recruiting
- Recruiting
University of Oradea
Oradea
Felicia Manole, manole.felicia@gmail.com
South Africa1 site, 1 recruiting
- Recruiting
Ahmed Alkhadi Hospital
Durban
Devesh Ramdhani, dr.d.ramdhani@gmail.com
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a new questionnaire
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.
Measured: Through study completion, an average of 6 months
Evaluation of the results
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.
Measured: Through study completion, an average of 6 months
Secondary outcomes (2)
Validation of a new questionnaire
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.
Measured: Through study completion, an average of 6 months
Evaluation of the results
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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (CRS) With and Without Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The European Forum for Research and Education in Allergy and Airway Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970977
- Sponsor's protocol ID
- S68027
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRS Questionnaire Validation Project
- ClinicalTrials.gov ID
- NCT06970977
- Acronym / sponsor ID
- S68027
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The European Forum for Research and Education in Allergy and Airway DiseasesUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, capable of giving consent, with certified CRS and no recent sinus surgery
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Not capable of giving informed consent
- No CRS
- Recent sinus surgery (within the last three months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Validation of a new questionnaire
Time frame: Through study completion, an average of 6 months
Evaluation of the results
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Northwestern University Feinberg School of Medicine
Chicago, United States
Brigham Sinus Center at Brigham and Women's Hospital
Boston, United States
32 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, run by The European Forum for Research and Education in Allergy and Airway Diseases at 32 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain, United States, Belgium, Germany, Greece and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a new questionnaire (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.