Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Conditions
Keywords
Tezepelumab, Chronic rhinosinusitis with nasal polyps (CRSwNP)
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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. * \- -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in sino-nasal symptoms measured by SNOT-22 total score at clinical routine visits. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in average cumulative SCS use in participants at clinical routine visits. | From Baseline up to 104 weeks, during clinical routine visit | To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab. |
| Proportion of participants with ≥ 500, 1000 and 2000 mg cumulative SCS at clinical routine visits. | From Baseline up to 104 weeks, during clinical routine visit | To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab. |
| 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. | 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. |
| Proportion of participants who reach 5 EUFOREA 2023 criteria at clinical routine visits. | From Baseline up to 104 weeks, during clinical routine visit | To describe proportion of participants who show response based on EUFOREA 2023 criteria. |
| Proportion of participants with AEs, SAEs. | 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. |
| 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 | 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. | 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. |
| 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 | 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. | 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. |
| Proportion of SST-16 responders (MCID from baseline = 3) at clinical routine visits. | 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. |
| 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. | 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. |
| Mean change from baseline in loss of smell score evaluated by VAS-Smell. | 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. |
| Proportion of VAS-Smell responders (MCID from baseline = -3.0; in participants with VAS-Smell ≥ 7 at baseline) at clinical routine visits. | 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. |
| Mean change from baseline in NP severity as measured by VAS-NP symptoms at clinical routine visits. | 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. |
| Proportion of NB responders (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 | To describe changes in nasal polyp (NP) severity as evaluated by VAS-NP. |
| Mean change from baseline in total NPS evaluated by nasal endoscopy by analysing data at clinical routine visits. | 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). |
| Proportion of NPS responders (MCID from baseline = -1.0) at clinical routine visits. | From Baseline up to 104 weeks, during clinical routine visit | To describe changes in nasal polyp score (NPS) following initiation of tezepelumab treatment. |
| Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the patient-reported NP control question at clinical routine visits. | 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. |
| Mean change from baseline in average SCS daily dose (only for long-term use) after initiating tezepelumab at clinical routine visits. | From Baseline up to 104 weeks, during clinical routine visit | To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab. |
| Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use at clinical routine visits. | From Baseline up to 104 weeks, during clinical routine visit | To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab. |
| Proportion of participants who reduced/stopped using SCS (only for long-term use) after initiating tezepelumab at clinical routine visits. | From Baseline up to 104 weeks, during clinical routine visitit | To describe overall prescribed systemic cortico steroids (SCS) in participants following initiation of tezepelumab. |
Countries
Germany
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed