[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653725":3},{"organization":4,"outcomesModule":7,"designInfo":108,"detailedDescription":107,"studyPopulation":111,"armGroups":112,"interventions":118,"overallOfficials":107,"centralContacts":126,"locations":107,"responsibleParty":132,"collaborators":107,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":136,"sex":142,"minAge":143,"maxAge":107,"enrollmentInfo":144,"targetDuration":107,"studyType":147,"phases":107,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":157,"whyStopped":107,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":107},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":107},[9],{"measure":10,"description":11,"timeFrame":12},"Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score","To describe the changes in participant-reported sinonasal symptoms as evaluated by sinonasal outcome test, 22 item (SNOT-22) total score.","at 24 weeks from initiation of tezepelumab treatment.",[14,17,21,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,73,76,79,82,86,90,92,94,96,98,101,103,105],{"measure":10,"description":15,"timeFrame":16},"To describe the changes in participant-reported sinonasal symptoms as SNOT-22 total score following initiation of tezepelumab treatment.","at 4, 12, and 52 weeks from initiation of tezepelumab treatment",{"measure":18,"description":19,"timeFrame":20},"Proportion of tezepelumab SNOT-22 responders","Proportion of responders in sinonasal symptoms as evaluated by SNOT-22 total score, defined as patients achieving the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.","up to 52 weeks",{"measure":22,"description":23,"timeFrame":20},"Odds to achieve tezepelumab SNOT-22 response","Odds to achieve tezepelumab SNOT-22 response meeting or exceeding the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.",{"measure":25,"description":26,"timeFrame":20},"Median time to first MCID-defined responder in sinonasal symptoms","To describe time to response in sinonasal symptoms as evaluated by SNOT-22 total score (time from baseline to the first occurrence of ≥ 8.9-point decrease).",{"measure":28,"description":29,"timeFrame":20},"Mean change from baseline in nasal blockage (NB) measured by VAS-NB","To describe changes in nasal blockage (NB) as evaluated by a visual analogue scale (VAS-NB) at each collected timepoint.",{"measure":31,"description":32,"timeFrame":20},"Proportion of NB responders","To describe proportion of NB responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline; in participants with VAS-NB ≥ 7 at baseline) at each collected timepoint.",{"measure":34,"description":35,"timeFrame":20},"Median time to meeting or exceeding the MCID for VAS-NB","Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-NB ≥ 7 at baseline.",{"measure":37,"description":38,"timeFrame":20},"Mean change from baseline in sense of smell score by VAS-smell","To describe changes in sense of smell as evaluated by VAS-Smell",{"measure":40,"description":41,"timeFrame":20},"Proportion of VAS-Smell responders","Proportion of VAS-Smell responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline) in participants with VAS-Smell ≥ 7 at baseline at each collected timepoint.",{"measure":43,"description":44,"timeFrame":20},"Median time to meeting or exceeding the MCID for VAS-Smell","Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-Smell ≥ 7 at baseline.",{"measure":46,"description":47,"timeFrame":20},"Mean change from baseline in NP severity as measured by VAS-NP symptoms","To describe changes in NP severity (VAS-NP) at each collected timepoint.",{"measure":49,"description":50,"timeFrame":20},"Proportion of VAS-NP symptom responders","To describe responders proportion of VAS-NP symptom responders, defined as patients achieving the MCID (≥ 2.5-point decrease from baseline) at each collected timepoint.",{"measure":52,"description":53,"timeFrame":20},"Median time to meeting or exceeding the MCID for VAS-NP symptom","Median time from baseline to the first occurrence of a ≥2.5-point decrease by each collected timepoint.",{"measure":55,"description":56,"timeFrame":20},"Mean change from baseline in total NPS evaluated by nasal endoscopy","To describe changes in nasal polyp score (NPS) at each collected timepoint.",{"measure":58,"description":59,"timeFrame":20},"Proportion of NPS responders","To describe proportion of NPS responders, defined as patients achieving the MCID (≥ 1.0-point decrease from baseline).",{"measure":61,"description":62,"timeFrame":20},"Median time to meeting or exceeding the MCID for NPS","To describe median time to meeting or exceeding the MCID for NPS by each collected timepoint.",{"measure":64,"description":65,"timeFrame":20},"Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question","To describe responder proportion for NP control.",{"measure":67,"description":68,"timeFrame":20},"Median time to first attainment of NP well control or NP complete control","To describe median time to first attainment of NP well control or NP complete control by each collected timepoint.",{"measure":70,"description":71,"timeFrame":72},"Average SCS daily dose after initiating tezepelumab","To describe overall systemic steroid use in participants, measured as average SCS daily dose (e.g., prednisone-equivalent milligrams).","From baseline up to 24 weeks and from baseline up to 52 weeks",{"measure":74,"description":75,"timeFrame":72},"Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use","To describe proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use.",{"measure":77,"description":78,"timeFrame":72},"Number of patients with ≥ 100, 200 and 400 mg cumulative SCS","Number of patients with ≥ 100, 200 and 400 mg cumulative SCS (e.g., prednisone-equivalent milligrams).",{"measure":80,"description":81,"timeFrame":72},"Time-to-first disease-related SCS use","Time-to-first disease-related SCS use, with cumulative incidence CRSwNP-related SCS use, asthma-related SCS use, other indications related SCS use and unknown indication-related SCS use.",{"measure":83,"description":84,"timeFrame":85},"Proportion of participants with AEs, SAEs, DAEs, and AESIs","To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.","Up to 52 weeks",{"measure":87,"description":88,"timeFrame":89},"Individual goal attainment","Proportion of participants achieving symptoms goal: SNOT-22\\* ≤ 20","At Week 24 and Week 52",{"measure":87,"description":91,"timeFrame":89},"Proportion of participants achieving Exacerbations goal: No SCS for sino-nasal exacerbations",{"measure":87,"description":93,"timeFrame":89},"Proportion of participants achieving Surgery goal: No sino-nasal surgery",{"measure":87,"description":95,"timeFrame":89},"Proportion of participants achieving Polyp burden goal: NPS improvement or NPS ≤2",{"measure":87,"description":97,"timeFrame":89},"Proportion of participants achieving olfaction goal: Smell PRO improvement following initiation of tezepelumab",{"measure":99,"description":100,"timeFrame":89},"Composite goal attainment","Proportion of participants achieving the following goals combinations: Combined symptom\u002Fexacerbation\u002Fsurgery",{"measure":99,"description":102,"timeFrame":89},"Proportion of participants achieving the following goals combinations: Combined symptom\u002Fexacerbation\u002Fsurgery\u002Fpolyp",{"measure":99,"description":104,"timeFrame":89},"Proportion of participants achieving the following goals combinations: Combined symptom\u002Fexacerbation\u002Fsurgery\u002Folfaction",{"measure":99,"description":106,"timeFrame":89},"Proportion of participants achieving the following goals combinations: Combined symptom\u002Fexacerbation\u002Fsurgery\u002Fpolyp burden\u002Folfaction",null,{"allocation":107,"interventionModel":107,"interventionModelDescription":107,"primaryPurpose":107,"observationalModel":109,"timePerspective":110,"maskingInfo":107},"COHORT","PROSPECTIVE","The study population will consist of male and female participants aged ≥ 18 years with diagnosed severe uncontrolled CRSwNP, for whom a tezepelumab biologic treatment for CRSWNP will be initiated. Eligible participant will be identified in routine care and enrolled prospectively at participating sites.",[113],{"label":114,"type":107,"description":115,"interventionNames":116},"Tezepelumab Treatment Group","Adult patients with severe CRSwNP who are newly initiated on subcutaneous (SC) tezepelumab. Eligible participants are those for whom therapy with systemic corticosteroids and\u002For surgery does not provide adequate disease control.",[117],"Drug: Tezepelumab",[119],{"type":120,"name":121,"description":122,"armGroupLabels":123,"otherNames":124},"DRUG","Tezepelumab","Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.",[114],[125],"Tezspire",[127],{"name":128,"role":129,"phone":130,"phoneExt":107,"email":131},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",{"type":133,"investigatorFullName":107,"investigatorTitle":107,"investigatorAffiliation":107,"oldNameTitle":107,"oldOrganization":107},"SPONSOR","100653725","tezepelumab-crswnp-real-world-study-crew-study-100653725",false,"NCT07790198","Tezepelumab CRSwNP Real World Study (CREW Study)","Tezepelumab CRSwNP Real World Study (CREW Study): Non-interventional Prospective, Observational Study in Patients With CRSwNP Treated by Tezepelumab, Evaluating Patient-reported Outcomes in Japan Real World Practice.","CREW","Inclusion Criteria:\n\n* Participant must be 18 years of age or older, at the time of signing the informed consent\n* Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1\n* Participants who will be enrolled after index date need to have at least SNOT-22 prior (maximum of 4 weeks) to index date\n* Documented SNOT-22 total score\\>=30, collected within the 4 weeks prior to the first tezepelumab dose (index date)\n* Treated per the Japanese Handbook for the Management of Chronic Rhinosinusitis with Nasal Polyps for at least 30 days prior to routine care visit 1\n* Physician decision that participant is eligible for treatment with tezepelumab according to local approved CRSwNP label and Optimal Clinical Use Guidelines\n* Patients must be able and willing to read and comprehend written instructions, to collect PROs and medication intake and to sign the informed consent document\n\nExclusion Criteria:\n\n* Patients who participate in an interventional clinical trial in the last 4 months\n* Known hypersensitivity to tezepelumab or any of its excipients\n* Patients who have received any biologic therapy for asthma or CRSwNP\n* Condition (acute or chronic) that, in the investigator's opinion, would limit the participant´s ability to complete questionnaires or participate in this study\n* Pregnancy or lactation period or planning pregnancy during the study period","ALL","18 Years",{"count":145,"type":146},100,"ESTIMATED","OBSERVATIONAL","The CREW Study is a non-interventional prospective, observational study in patients with CRSwNP that will evaluate patient-reported outcomes and describe the proportion of participants achieving treatment goals.)",[150],"Chronic Rhinosinusitis With Nasal Polyps",[121,152,153,154,155,156],"Chronic rhinosinusitis with nasal polyps","CRSwNP","Observational Study","Patient-Reported Outcomes","Japan","NOT_YET_RECRUITING","2026-08-24",{"date":160,"type":161},"2026-08-27","ACTUAL",{"date":163,"type":146},"2026-10-01",{"date":165,"type":146},"2029-09-28",{"name":5,"class":6}]