Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and…
PETRICHOR is a prospective, non-treatment, 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).
Official registry: https://clinicaltrials.gov/study/NCT07633158 · AstraZeneca · enrollment listed as 200
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 200 people at 19 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
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)
Primary outcome (registry wording): Mean change from baseline in sino-nasal symptoms measured by SNOT-22 total score at clinical routine visits.
Who it is for (from inclusion criteria)
- Ages 18 Years to 130 Years
- \- 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 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
Who the registry excludes
- \- 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
Public study contact (from the registry)
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
19 listed- Research Site — Berlin, Germany (recruiting)
- Research Site — Bochum, Germany (recruiting)
- Research Site — Braunschweig, Germany (recruiting)
- Research Site — Dortmund, Germany (recruiting)
- Research Site — Dresden, Germany (recruiting)
- Research Site — Erfurt, Germany (recruiting)
- Research Site — Göppingen, Germany (recruiting)
- Research Site — Hagen, Germany (recruiting)
- Research Site — Hamburg, Germany (recruiting)
- Research Site — Heilbronn, Germany (recruiting)
- Research Site — Jena, Germany (recruiting)
- Research Site — Kiel, Germany (recruiting)
FAQ about this NCT record
Is NCT07633158 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07633158?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07633158?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary