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)

Обзор

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.

Первичные конечные точки

• Mean change from baseline in sino-nasal symptoms measured by SNOT-22 total score at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during each routine care visit]

Вторичные конечные точки (12)

• Proportion of SNOT-22 total score responders (minimal clinically important difference (MCID) from baseline = -8.9) at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Mean change from baseline in NB measured by VAS-NB at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Proportion of NB responders (minimal clinically important difference (MCID) from baseline = -3.0; in participants with VAS-NB ≥ 7 at baseline) at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Mean change from baseline in loss of smell score evaluated by SST-12/16. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Proportion of SST-16 responders (MCID from baseline = 3) at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Proportion of participants in each category of olfactory function based on SST-12 results (normosmia 11-12, hyposmia 7-10 and anosmia 0-6) at clinical routine visits. Participants with a SST-16 result will be converted to the range of SST-12 results. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Mean change from baseline in loss of smell score evaluated by VAS-Smell. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Proportion of VAS-Smell responders (MCID from baseline = -3.0; in participants with VAS-Smell ≥ 7 at baseline) at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Mean change from baseline in NP severity as measured by VAS-NP symptoms at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Proportion of NB responders (MCID from baseline = -3.0; in participants with VAS-NB ≥ 7 at baseline) at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Mean change from baseline in total NPS evaluated by nasal endoscopy by analysing data at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]
• Proportion of NPS responders (MCID from baseline = -1.0) at clinical routine visits. [Срок оценки: From Baseline up to 104 weeks, during clinical routine visit]

Критерии участия

Критерии включения

• \- 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.
• \- -

Критерии исключения

• \- 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.
• \- -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 8 центров

• Research Site — Hamburg
• Research Site — Kiel
• Research Site — München
• Research Site — Neuenhagen
• Research Site — Rosenheim
• Research Site — Starnberg
• Research Site — Tübingen
• Research Site — Wiesbaden

Идентификаторы

NCT: NCT07633158 · D5242R00004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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