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

NCT06815211 | Not Yet Recruiting

• 1 other identifier: GenreCRS_2024_V1.0
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Rhinosinusitis (CRS); Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Keywords

CRSwNP; CRSsNP; Nasal Polyps; Registry; Patient Reported Outcome Measures (PROM)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Peak Nasal Inspiratory Flow (PNIF)

  1 year

• Blood eosinophils

  1 year

• Lund-Mackay Score

  1 year

• Allergic Rhinitis Visual Analogue Scale (AR-VAS)

  1 year

• Forced Expiratory Volume in 1 Second (FEV1)

  1 year

Study Arms (3)

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jan Hagemann, Dr. med.

CONTACT

+49611308608273; jan.hagemann@allergiezentrum.org

Friederike Bärhold, Dr. med.

CONTACT

+49611308608273; friederike.baerhold@allergiezentrum.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-06