Chronic Rhinosinusitis (CRS)GenreCRSNCT06815211
The German National CRS Registry (GenreCRS): Clinical Evaluation of the New European Academy for Allergy and Clinical Immunology (EAACI) Criteria for CRSwNP Disease Control, Remission and Cure in a Real-World Evidence Study Approach
An observational study of Chronic Rhinosinusitis (CRS) and Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, run by Ärzteverband Deutscher Allergologen e.V..
Trial summary
The objective of the study is to establish a registry of patients diagnosed with Chronic Rhinosinusitis with and without Nasal Polyps (CRSwNP/CRSsNP) to collect comprehensive longitudinal real-world evidence from specialised treatment centres in Germany. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2028
- How long will I take part?
- 1 Year
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients above the age of 18 years of any gender with the diagnosis of CRSwNP and CRSsNP treated by a specialized treatment centre in Germany that is part of the German CRS registry network will be included in the study.
Who may be able to join
- Patients above the age of 12 years
- Patients who are diagnosed with CRS according to internationally valid guidelines (EPOS 2020)
- Patients who provide written informed consent or by a legal representative
Who cannot join
- Patients below the age of 12 years at initiation
- Patients who do not provide written consent or withdraw their consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study for Real-world Evaluation of the Novel European Academy for Allergy and Clinical Immunology (EAACI) Criteria for Disease Control, Remission and Cure in CRSwNP Utilizing the German National CRS Registry (GENRE CRS)
The objective of the study is to establish a registry of patients diagnosed with Chronic Rhinosinusitis with and without Nasal Polyps (CRSwNP/CRSsNP) to collect comprehensive longitudinal real-world evidence from specialised treatment centres in Germany. The primary analysis will concentrate on the treatment efficacy and safety of biologic drugs with a focus on defining disease Control, Remission, and Cure as well as to validate the corresponding clinical evaluation criteria.
Read the detailed description
The German national CRS registry (Genre CRS) is a nationwide registry for patients with CRSsNP and CRSwNP that aims to include more than 250 centres in Germany. Genre CRS is operated by the German Societies of Allergology (AeDA) and Otorhinolaryngology (DGHNO) and is based on most advanced digital health technologies, including a wide variety of collected parameters. Additionally, patient-reported outcome measures will be captured via a smart phone app and submitted directly to the registry database. This registry is the first of its kind in Germany. It will be the foundation for answering many critical/pivotal research questions that depend on high quality, extensive longitudinal data provided by the registry for future studies.
One important field of application will be the long-term assessment of RWE on therapeutic antibodies, also known as "biologics". Biologics are a novel treatment option for patients with severe CRSwNP and have led to tremendous treatment success. Chronically ill patients with a long history of severe symptoms and impaired quality of life can now experience a significant improvement in CRSwNP symptoms when treated with a biologic, which has prompted the discussion about disease Control, Remission, and even Cure. So far, internationally accepted and clinically evaluated definitions of these terms are lacking, but would greatly assist clinicians in developing therapeutic strategies, particularly for the long-term management of chronically affected patients. The criteria currently in use, although generally accepted, are not evidence-based and do not reflect the perspectives of patients and healthcare providers. An international expert working group of the European Academy for Allergy and Clinical Immunology (EAACI) has therefore developed such criteria, which now need to be clinically evaluated and validated using the comprehensive longitudinal data from Genre CRS.
Data collection includes a variety of parameters involved in the treatment with biologics, analysis of their long-term efficacy and safety including but not limited to:
- Polyp Size
- SNOT22
- Visual analog scales for nasal congestion, rhinorrhea, pressure/facial pain, sense of smell
- Olfactory function
- Necessity for rescue treatment (sinus surgery, OCS)
- Parameters of co-morbid diseases
- Type 2 biomarkers
- Keywords
- CRSwNP, CRSsNP, Nasal Polyps, Registry, Patient Reported Outcome Measures (PROM)
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sinus surgery | all patients who received sinus surgery during the observation period | |
| biologic treatment | all patients who are treated with a biologic drug | |
| non-biologic, non-surgery | all patients without surgery or biologic treatment during observation period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Polyp Score
Size of nasal polyps from 0-4 per side, with 0=no polyps to 4=large polyps reaching the bottom of the nasal cavity
Measured: 1 year
University of Pennsylvania Smell Identification Test (UPSIT)
smell identification test, 0-40 points, with 0 being the lowest smell function and 40 an excellent smell function
Measured: 1 year
Sniffin' Sticks Identification Test 12
Smell identification test with 12 items, range 0-12, the higher the score, the better the smell function (0=anosmia, 12=normosmia)
Measured: 1 year
Sniffin' Sticks Identification Test 16
Smell identification test with 16 items, range 0-12, the higher the score, the better the smell function (0=anosmia, 12=normosmia)
Measured: 1 year
Sinonasal Outcome Test 22 (SNOT22)
quality of life questionnaire with 22 items (score 0-22). 0=no impairment, 22=maximum impairment in all categories
Measured: 1 year
Rescue Treatment
Number of courses of systemic corticosteroids and number of sinus surgeries necessary due to poor treatmentcontrol or exacerbation of CRS-symptoms
Measured: 1 year
Secondary outcomes (7)
Peak Nasal Inspiratory Flow (PNIF)
measured in l/min
Measured: 1 year
Blood eosinophils
1/µl
Measured: 1 year
Lund-Mackay Score
opacification of nasal sinuses in CT imaging: scores 0-24 with 0=no opacification and 24 complete opacification of all sinuses
Measured: 1 year
Allergic Rhinitis Visual Analogue Scale (AR-VAS)
symptom severity of allergic rhinitis on a visual analogue scale with 0=no symptoms to 10=worst symptoms imaginable
Measured: 1 year
Forced Expiratory Volume in 1 Second (FEV1)
lung function measured in l
Measured: 1 year
Fractional exhaled nitric oxide (FeNO)
measured in ppb
Measured: 1 year
Immunoglobulin E (IgE)
kU/l
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study startOct 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionOct 2028 (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)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ärzteverband Deutscher Allergologen e.V.
- Sponsor type
- University, hospital or other
- Collaborators
- German Society of Otorhinolaryngology, Head and Neck Surgery
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815211
- Sponsor's protocol ID
- GenreCRS_2024_V1.0
- Acronym
- GenreCRS
- Status last verified
- Jun 2025
- First submitted
- 28 Jan 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for Real-world Evaluation of the Novel European Academy for Allergy and Clinical Immunology (EAACI) Criteria for Disease Control, Remission and Cure in CRSwNP Utilizing the German National CRS Registry (GENRE CRS)
- ClinicalTrials.gov ID
- NCT06815211
- Acronym / sponsor ID
- GenreCRS / GenreCRS_2024_V1.0
- Keywords
- CRSwNP, CRSsNP, Nasal Polyps, Registry, Patient Reported Outcome Measures (PROM)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ärzteverband Deutscher Allergologen e.V.University, hospital or other
- Collaborators
- German Society of Otorhinolaryngology, Head and Neck Surgery
- Study start
- Oct 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 7 Feb 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 objective of the study is to establish a registry of patients diagnosed with Chronic Rhinosinusitis with and without Nasal Polyps (CRSwNP/CRSsNP) to collect comprehensive longitudinal real-world evidence from specialised treatment centres in Germany. The primary analysis will concentrate on the treatment efficacy and safety of biologic drugs with a focus on defining disease Control, Remission, and Cure as well as to validate the corresponding clinical evaluation criteria.
Detailed description
The German national CRS registry (Genre CRS) is a nationwide registry for patients with CRSsNP and CRSwNP that aims to include more than 250 centres in Germany. Genre CRS is operated by the German Societies of Allergology (AeDA) and Otorhinolaryngology (DGHNO) and is based on most advanced digital health technologies, including a wide variety of collected parameters. Additionally, patient-reported outcome measures will be captured via a smart phone app and submitted directly to the registry database. This registry is the first of its kind in Germany. It will be the foundation for answering many critical/pivotal research questions that depend on high quality, extensive longitudinal data provided by the registry for future studies.
One important field of application will be the long-term assessment of RWE on therapeutic antibodies, also known as "biologics". Biologics are a novel treatment option for patients with severe CRSwNP and have led to tremendous treatment success. Chronically ill patients with a long history of severe symptoms and impaired quality of life can now experience a significant improvement in CRSwNP symptoms when treated with a biologic, which has prompted the discussion about disease Control, Remission, and even Cure. So far, internationally accepted and clinically evaluated definitions of these terms are lacking, but would greatly assist clinicians in developing therapeutic strategies, particularly for the long-term management of chronically affected patients. The criteria currently in use, although generally accepted, are not evidence-based and do not reflect the perspectives of patients and healthcare providers. An international expert working group of the European Academy for Allergy and Clinical Immunology (EAACI) has therefore developed such criteria, which now need to be clinically evaluated and validated using the comprehensive longitudinal data from Genre CRS.
Data collection includes a variety of parameters involved in the treatment with biologics, analysis of their long-term efficacy and safety including but not limited to:
- Polyp Size
- SNOT22
- Visual analog scales for nasal congestion, rhinorrhea, pressure/facial pain, sense of smell
- Olfactory function
- Necessity for rescue treatment (sinus surgery, OCS)
- Parameters of co-morbid diseases
- Type 2 biomarkers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sinus surgery | – | –all patients who received sinus surgery during the observation period |
| biologic treatment | – | –all patients who are treated with a biologic drug |
| non-biologic, non-surgery | – | –all patients without surgery or biologic treatment during observation period |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients above the age of 18 years of any gender with the diagnosis of CRSwNP and CRSsNP treated by a specialized treatment centre in Germany that is part of the German CRS registry network will be included in the study.
Key inclusion criteria (3 listed)
- Patients above the age of 12 years
- Patients who are diagnosed with CRS according to internationally valid guidelines (EPOS 2020)
- Patients who provide written informed consent or by a legal representative
Key exclusion criteria (2 listed)
- Patients below the age of 12 years at initiation
- Patients who do not provide written consent or withdraw their consent
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
Nasal Polyp Score
Time frame: 1 year
Size of nasal polyps from 0-4 per side, with 0=no polyps to 4=large polyps reaching the bottom of the nasal cavity
University of Pennsylvania Smell Identification Test (UPSIT)
Time frame: 1 year
smell identification test, 0-40 points, with 0 being the lowest smell function and 40 an excellent smell function
Sniffin' Sticks Identification Test 12
Time frame: 1 year
Smell identification test with 12 items, range 0-12, the higher the score, the better the smell function (0=anosmia, 12=normosmia)
Sniffin' Sticks Identification Test 16
Time frame: 1 year
Smell identification test with 16 items, range 0-12, the higher the score, the better the smell function (0=anosmia, 12=normosmia)
Sinonasal Outcome Test 22 (SNOT22)
Time frame: 1 year
quality of life questionnaire with 22 items (score 0-22). 0=no impairment, 22=maximum impairment in all categories
Rescue Treatment
Time frame: 1 year
Number of courses of systemic corticosteroids and number of sinus surgeries necessary due to poor treatmentcontrol or exacerbation of CRS-symptoms
7 secondary outcomes
Peak Nasal Inspiratory Flow (PNIF)
Time frame: 1 year
Blood eosinophils
Time frame: 1 year
Lund-Mackay Score
Time frame: 1 year
Allergic Rhinitis Visual Analogue Scale (AR-VAS)
Time frame: 1 year
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 1 year
Fractional exhaled nitric oxide (FeNO)
Time frame: 1 year
Immunoglobulin E (IgE)
Time frame: 1 year
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 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis (CRS) and Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, run by Ärzteverband Deutscher Allergologen e.V..
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 2 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: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jan Hagemann, Dr. med. (+49611308608273, jan.hagemann@allergiezentrum.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Polyp Score (time frame: 1 year). The study lists 6 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 4 Jun 2025.