Observational Study of Tezepelumab Treatment in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps CRSwNP in Routine Care

What this Trial Is About

Researchers are conducting a prospective, non-interventional, single-arm study called PETRICHOR in Germany to evaluate real-world clinical and patient-reported outcomes in adults with severe chronic rhinosinusitis with nasal polyps CRSwNP. The study focuses on patients whose disease is not well controlled by systemic corticosteroids or surgery and who are newly starting treatment with tezepelumab as part of routine clinical care. Treatment decisions are made by patients and their doctors independently of the study, and the study aims to observe outcomes without adding extra diagnostic or monitoring procedures. Participants receive subcutaneous tezepelumab in accordance with approved guidelines for CRSwNP. The study does not intervene but collects data during routine clinical visits over a period of up to 104 weeks. Treatment and monitoring follow usual clinical practice, with no additional procedures required by the study protocol. During the study, participants attend routine clinical visits where researchers collect data on symptom changes and quality of life using tools like the SNOT-22 questionnaire, smell tests, nasal endoscopy, and patient-reported measures. The study also tracks corticosteroid use, response rates, and safety events over two years. Data collection occurs at baseline and regularly during routine care visits to understand treatment outcomes and disease control in a real-world setting.

Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)