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.
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
Patients below the age of 12 years at initiation
Patients who do not provide written consent or withdraw their consent
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.
Cohort
Prospective
Not listed
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
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
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)
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)
Peak Nasal Inspiratory Flow (PNIF)
measured in l/min
Blood eosinophils
1/µl
Lund-Mackay Score
opacification of nasal sinuses in CT imaging: scores 0-24 with 0=no opacification and 24 complete opacification of all sinuses
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
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Ärzteverband Deutscher Allergologen e.V.
Lead sponsor
German Society of Otorhinolaryngology, Head and Neck Surgery
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
