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)

AstraZeneca200 enrolled

Overview

PETRICHOR is a prospective, non-interventional, single-arm, multi-centre study in Germany evaluating real-world clinical and patient-reported outcomes in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), whose disease is inadequately controlled with systemic corticosteroids (SCS) and/or surgery. Eligible participants are newly initiated on subcutaneous tezepelumab in routine clinical practice, in accordance with the European Summary of Product Characteristics (SmPC). Treatment decisions are made jointly by patients and their physicians, independent of study enrollment. No additional diagnostic or monitoring procedures are applied; data are collected using epidemiological methods at baseline and during routine clinical visits for up to 104 weeks.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \- Participant must be 18 years of age or older, at the time of signing the informed consent. * \- Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1. * \- Stable standard of care (SoC) treatment with Intranasal corticosteroids (INCS) for CRSwNP for at least 30 days prior to routine care visit 1. * \- Physician decision that participant is eligible for treatment with Tezepelumab according to locally approved CRSwNP label. * Participants must be able and willing to read and comprehend written instructions, to collect Patient-reported outcome (PROs) and medication intake via app or alternative mode (paper) and to sign the informed consent document. Use of the mobile app is optional; participants without smartphones will not be excluded. Mode of data capture will be recorded and adjusted for in analyses where relevant. * \- Participants who will be enrolled after index date need to have at least one measurement for SNOT-22 prior (within a maximum of 4 weeks) to index date. * \- - Exclusion Criteria: * \- Participants who participate in an observational study that might influence the assessment of the current study (participants can be part of the German National Registry for Chronic rhinosinusitis (GENRE-CRS)); or participate in an interventional clinical trial in the last 3 months. * \- Concurrent biologic therapy for CRSwNP or Asthma except where the last dose was administered ≥ 30 days. Stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment) is allowed. * \- Endoscopic NP surgery within 6 months prior to index date. * \- Condition (acute or chronic) that, in the investigator's opinion, would limit the participant's ability to complete questionnaires or participate in this study. * \- History of documented anaphylactic reactions/hypersensitivity/serious allergic reactions (immune complex disease) following any biologic therapy. * \- Known hypersensitivity to Tezepelumab or any of its excipients. * \- Pregnancy, planned pregnancy or lactation period. * \- -

Outcomes

Primary Outcomes

Mean change from baseline in sino-nasal symptoms measured by SNOT-22 total score at clinical routine visits.

To describe changes from baseline in patient-reported sino-nasal symptoms as evaluated by Sinonasal outcome test (SNOT)-22 total score following initiation of tezepelumab treatment. SNOT-22 scores are participant-reported and assess physical problems, functional limitations and emotional consequences of SinoNasal conditions. Patient-reported symptom severity and symptom impact over the past 2 weeks are captured via a 6-point scale (0-No Problem to 5-Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes).

Time frame: From Baseline up to 104 weeks, during each routine care visit

Secondary Outcomes

Proportion of SNOT-22 total score responders (minimal clinically important difference (MCID) from baseline = -8.9) at clinical routine visits.

To describe responder proportion in sino-nasal symptoms as evaluated by SNOT-22 total score following initiation of tezepelumab treatment.