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.
- 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 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.
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.
Cohort
Prospective
Not listed
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).
Proportion of SNOT-22 total score responders (minimal clinically important difference (MCID) from baseline = -8.9) at clinical routine visits.
To describe responder proportion in sino-nasal symptoms as evaluated by SNOT-22 total score following initiation of tezepelumab treatment.
Mean change from baseline in NB measured by VAS-NB at clinical routine visits.
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.
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.
To describe changes in nasal blockage (NB) as evaluated by a VAS-NB following initiation of tezepelumab treatment.
Mean change from baseline in loss of smell score evaluated by SST-12/16.
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.
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