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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)

24 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Dortmund, Allemagne
        • Recrutement
        • Research Site
      • Hamburg, Allemagne
        • Recrutement
        • Research Site
      • Heilbronn, Allemagne
        • Recrutement
        • Research Site
      • Jena, Allemagne
        • Recrutement
        • Research Site
      • Kiel, Allemagne
        • Recrutement
        • Research Site
      • München, Allemagne
        • Recrutement
        • Research Site
      • Neuenhagen, Allemagne
        • Recrutement
        • Research Site
      • Rosenheim, Allemagne
        • Recrutement
        • Research Site
      • Starnberg, Allemagne
        • Recrutement
        • Research Site
      • Tübingen, Allemagne
        • Recrutement
        • Research Site
      • Wiesbaden, Allemagne
        • Recrutement
        • Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.
  • - -

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean change from baseline in sino-nasal symptoms measured by SNOT-22 total score at clinical routine visits.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of SNOT-22 total score responders (minimal clinically important difference (MCID) from baseline = -8.9) at clinical routine visits.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AstraZeneca

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 juin 2026

Achèvement primaire (Estimé)

31 décembre 2029

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

3 juin 2026

Première soumission répondant aux critères de contrôle qualité

3 juin 2026

Première publication (Réel)

8 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • D5242R00004

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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