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 (GenreCRS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps; Chronic Rhinosinusitis (CRS)

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jan Hagemann, Dr. med.; Phone Number: +49611308608273; Email: jan.hagemann@allergiezentrum.org
• Study Contact Backup: Name: Friederike Bärhold, Dr. med.; Phone Number: +49611308608273; Email: friederike.baerhold@allergiezentrum.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients below the age of 12 years at initiation
• Patients who do not provide written consent or withdraw their consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	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)	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	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Nasal Inspiratory Flow (PNIF)	measured in l/min	1 year
Blood eosinophils	1/µl	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	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	1 year
Forced Expiratory Volume in 1 Second (FEV1)	lung function measured in l	1 year
Fractional exhaled nitric oxide (FeNO)	measured in ppb	1 year
Immunoglobulin E (IgE)	kU/l	1 year

Collaborators and Investigators

• Sponsor: Ärzteverband Deutscher Allergologen e.V.
• Collaborators: German Society of Otorhinolaryngology, Head and Neck Surgery

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Registry; CRSwNP; Nasal Polyps; CRSsNP; Patient Reported Outcome Measures (PROM)
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Paranasal Sinus Diseases; Polyps; Rhinosinusitis; Nasal Polyps; Sinusitis
• Other Study ID Numbers: GenreCRS_2024_V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No