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)

NCT07633158 | Recruiting

• 1 other identifier: D5242R00004
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Keywords

Tezepelumab; Chronic rhinosinusitis with nasal polyps (CRSwNP)

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (21)

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

  From Baseline up to 104 weeks, during clinical routine visit

• Mean change from baseline in NB measured by VAS-NB at clinical routine visits.

  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.

  From Baseline up to 104 weeks, during clinical routine visit

• Mean change from baseline in loss of smell score evaluated by SST-12/16.

  From Baseline up to 104 weeks, during clinical routine visit

• Proportion of SST-16 responders (MCID from baseline = 3) at clinical routine visits.

  From Baseline up to 104 weeks, during clinical routine visit

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \- 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.
• \- -

You may not qualify if:

• \- 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.
• \- -

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

Hamburg, Germany

RECRUITING

Research Site

Kiel, Germany

RECRUITING

Research Site

München, Germany

RECRUITING

Research Site

Neuenhagen, Germany

RECRUITING

Research Site

Rosenheim, Germany

RECRUITING

Research Site

Starnberg, Germany

RECRUITING

Research Site

Tübingen, Germany

RECRUITING

Research Site

Wiesbaden, Germany

RECRUITING

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.

Locations

DE (8)