An observational study in Chronic Rhinosinusitis (CRS) and Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, sponsored by Ärzteverband Deutscher Allergologen e.V.. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Ärzteverband Deutscher Allergologen e.V. · Observational
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.
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:
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 47 observational studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →This is the only study on the registry with Ärzteverband Deutscher Allergologen e.V. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
all patients who received sinus surgery during the observation period
all patients who are treated with a biologic drug
all patients without surgery or biologic treatment during observation period
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 1 year
Peak Nasal Inspiratory Flow (PNIF)
measured in l/min
Time frame: 1 year
Blood eosinophils
1/µl
Time frame: 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
Time frame: 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
Time frame: 1 year
Forced Expiratory Volume in 1 Second (FEV1)
lung function measured in l
Time frame: 1 year
Fractional exhaled nitric oxide (FeNO)
measured in ppb
Time frame: 1 year
Immunoglobulin E (IgE)
kU/l
Time frame: 1 year
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2025; primary completion for May 2028, 31 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.