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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) (PETRICHOR)

2026年8月24日 更新者：AstraZeneca
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.

調査の概要

状態

募集

条件

研究の種類

観察的

入学 (推定)

200

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • ドイツ
      • Dortmund、ドイツ
        • 募集
        • Research Site
      • Hamburg、ドイツ
        • 募集
        • Research Site
      • Heilbronn、ドイツ
        • 募集
        • Research Site
      • Jena、ドイツ
        • 募集
        • Research Site
      • Kiel、ドイツ
        • 募集
        • Research Site
      • München、ドイツ
        • 募集
        • Research Site
      • Neuenhagen、ドイツ
        • 募集
        • Research Site
      • Rosenheim、ドイツ
        • 募集
        • Research Site
      • Starnberg、ドイツ
        • 募集
        • Research Site
      • Tübingen、ドイツ
        • 募集
        • Research Site
      • Wiesbaden、ドイツ
        • 募集
        • Research Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The study population will consist of male and female participants aged ≥ 18 years treated by ear-nose-throat specialists with diagnosed severe uncontrolled CRSwNP, for whom a tezepelumab biologic treatment for CRSwNP will be initiated in line with the applicable European Summary of Product Characteristics (SmPC) within routine clinical practice. The decision to initiate or switch to Tezepelumab must be made by the treating physician according to the participant's medical needs and a positive benefit/risk balance. Eligible patients will be included into the study after and independently of the treating physician's treatment and diagnostic decisions. Each participant should meet all the Inclusion Criteria and none of the Exclusion Criteria for this study in order to be part of the study.

説明

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.
  • - -

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean change from baseline in sino-nasal symptoms measured by SNOT-22 total score at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during each routine care visit

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).
From Baseline up to 104 weeks, during each routine care visit

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of SNOT-22 total score responders (minimal clinically important difference (MCID) from baseline = -8.9) at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe responder proportion in sino-nasal symptoms as evaluated by SNOT-22 total score following initiation of tezepelumab treatment.
From Baseline up to 104 weeks, during clinical routine visit
Mean change from baseline in NB measured by VAS-NB at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit

To describe changes in nasal blockage (NB) as evaluated by a visual analog scale (VAS)-NB following initiation of tezepelumab treatment.

VAS-NB is a 10-cm line with a bottom anchor of 0 = None and 10 = As bad as you can imagine. Participants will be requested to answer the following question: Please rate your [NB] at its worst over the previous 14 days.
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.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe changes in nasal blockage (NB) as evaluated by a VAS-NB following initiation of tezepelumab treatment.
From Baseline up to 104 weeks, during clinical routine visit
Mean change from baseline in loss of smell score evaluated by SST-12/16.
時間枠：From Baseline up to 104 weeks, during clinical routine visit

To describe changes in sense of smell as evaluated by Sniffin Sticks Test (SST)-12/16 odours following initiation of tezepelumab treatment.

SST-12/16 is a validated tool to assess the chemosensory olfactory performance of an individual. The SST is based on 12 or 16 pen-like odor dispensing devices. The participant will have to name the smell using a multiple-choice form which offers 4 answers for every pen, only one of the answers is correct. Participants with a SST-16 result will be converted to the range of SST-12 results through percentage based conversion.
From Baseline up to 104 weeks, during clinical routine visit
Proportion of SST-16 responders (MCID from baseline = 3) at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe changes in sense of smell as evaluated by SST-12/16 odours following initiation of tezepelumab treatment.
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.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe changes in sense of smell as evaluated by SST-12/16 odours following initiation of tezepelumab treatment.
From Baseline up to 104 weeks, during clinical routine visit
Mean change from baseline in loss of smell score evaluated by VAS-Smell.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe changes in sense of smell as evaluated by VAS-Smell following initiation of tezepelumab treatment.
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.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe changes in sense of smell as evaluated by VAS-Smell following initiation of tezepelumab treatment.
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.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe changes in nasal polyp (NP) severity as evaluated by VAS-NP. The VAS-NP is a 10-cm line with a bottom anchor of 0 = None and 10 = As bad as you can imagine. Participants will be requested to answer the following question: Please rate your [loss of smell] at its worst over the previous 14 days.
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.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe changes in nasal polyp (NP) severity as evaluated by VAS-NP.
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.
時間枠：From Baseline up to 104 weeks, during clinical routine visit

To describe changes in nasal polyp score (NPS) following initiation of tezepelumab treatment.

The NPS is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy. Total NPS is graded based on polyp size described in Gevaert et al. 2023.

(0=no polyps; 1= Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate ; 2= Polyps reaching below the lower border of the middle turbinate; 3= Polyps reaching the lower border of the inferior turbinate or a middle meatal polyp with a score of 2 with any additional polyp medial to the middle turbinate; 4= Large polyps causing complete or near complete obstruction of the inferior nasal cavity i. e., touching the floor of the nose).
From Baseline up to 104 weeks, during clinical routine visit
Proportion of NPS responders (MCID from baseline = -1.0) at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe changes in nasal polyp score (NPS) following initiation of tezepelumab treatment.
From Baseline up to 104 weeks, during clinical routine visit
Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the patient-reported NP control question at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit

To describe responder proportion for NP control evaluated by patient-reported NP control question following initiation of tezepelumab treatment.

The NP control question was adapted from the asthma control test (ACT) and asks participants to rate how controlled their NP condition has been over the past 2 weeks. Response options are: Not controlled at all, Poorly controlled, Somewhat controlled, Well controlled, and Completely controlled.
From Baseline up to 104 weeks, during clinical routine visit
Mean change from baseline in average SCS daily dose (only for long-term use) after initiating tezepelumab at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab.
From Baseline up to 104 weeks, during clinical routine visit
Proportion of participants who reduced/stopped using SCS (only for long-term use) after initiating tezepelumab at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visitit
To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab.
From Baseline up to 104 weeks, during clinical routine visitit
Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab.
From Baseline up to 104 weeks, during clinical routine visit
Mean change from baseline in average cumulative SCS use in participants at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab.
From Baseline up to 104 weeks, during clinical routine visit
Proportion of participants with ≥ 500, 1000 and 2000 mg cumulative SCS at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab.
From Baseline up to 104 weeks, during clinical routine visit
Proportion of participants who are considered as 'good' (4-5 criteria), 'moderate' (2-3 criteria) or 'no - poor response' (0-1 criteria) based on EUFOREA 2023 criteria.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe proportion of participants who show response based on European Forum for Research and Education in Allergy and Airway diseases (EUFOREA) 2023 criteria (1: Reduced NP size (NPS), 2: Reduced need for SCS/ salvage surgery, 3: improved QoL (SNOT-22), 4: improved sense of smell (VAS-Smell or SST), 5: Reduced impact of comorbidities (ACT for asthma)) following initiation of tezepelumab.
From Baseline up to 104 weeks, during clinical routine visit
Proportion of participants who reach 5 EUFOREA 2023 criteria at clinical routine visits.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe proportion of participants who show response based on EUFOREA 2023 criteria.
From Baseline up to 104 weeks, during clinical routine visit
Proportion of participants with AEs, SAEs.
時間枠：From Baseline up to 104 weeks, during clinical routine visit
To describe the safety and tolerability of tezepelumab treatment. Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness.
From Baseline up to 104 weeks, during clinical routine visit

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AstraZeneca

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月10日

一次修了 (推定)

2029年12月31日

研究の完了 (推定)

2029年12月31日

試験登録日

最初に提出

2026年6月3日

QC基準を満たした最初の提出物

2026年6月3日

最初の投稿 (実際)

2026年6月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月25日

QC基準を満たした最後の更新が送信されました

2026年8月24日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • D5242R00004

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD 共有時間枠

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共有アクセス基準

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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