Dupilumab-behandlingseffekter i en etnisk forskelligartet befolkning med kronisk rhinosinusitis med nasal polypose (CRSwNP)
9. september 2026 opdateret af: Montefiore Medical Center
Dupilumab-behandlingseffekter i en etnisk forskelligartet befolkning med kronisk rhinosinusitis med nasal polypose (CRSwNP)
Den centrale hypotese i denne undersøgelse er, at tilføjelsen af dupilumab-behandling til standard-of-care intranasale kortikosteroider vil forbedre patientrapporterede mål for sygdomsaktivitet og lugtesans i en kohorte af primært etniske og racemæssige minoritetspatienter med CRSwNP
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
For det første vil det bekræfte effektiviteten af dupilumab i behandlingen af CRSwNP hos etniske og racemæssige minoritetspatienter, som traditionelt har været underrepræsenteret i eksisterende kliniske forsøg med biologiske lægemidler i CRSwNP. For det andet vil denne forskning etablere en biomarkør for terapeutisk respons på dupilumab, der identificerer den biologiske effekt af dupilumab hos CRSwNP-patienter og dets sammenhæng med symptomforbedring.
Endelig vil efterforskerne måle effekten af dupilumab på astmasymptomer og lungefunktion hos patienter med CRSwNP og komorbid astma.
Der vil være et screeningsbesøg, efterfulgt af et baseline-besøg, hvor medicinen vil blive givet. Opfølgningsbesøg vil blive planlagt efter 2 uger og derefter 16 uger fra baseline. Langtidsbesøg vil finde sted om 36 og 52 uger.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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New York
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The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
60 patienter med lægediagnosticeret CRSwNP, med eller uden komorbid astma, der opfylder indikationskriterier for FDA-godkendt brug af Dupilumab.
Disse patienter vil være 18 år og ældre og vil have en forsikring, der tillader Dupilumab-dækning eller Dupilumab-dækning opnået gennem "Dupixent MyWay Program"
Beskrivelse
Inklusionskriterier:
- Patienter med lægediagnosticeret CRSwNP, med eller uden komorbid astma, der opfylder indikationskriterier for FDA-godkendt brug af Dupilumab.
- Patienter i alderen 18 år og ældre.
- Patient villig til at give samtykke til at deltage i undersøgelsen.
- Patienter med forsikring, der tillader Dupilumab-dækning eller Dupilumab-dækning opnået gennem "Dupixent MyWay Program"
Ekskluderingskriterier:
- Alder under 18
- Mistænkt eller diagnosticeret allergisk svampe rhinosinusitis.
- Mistænkt eller diagnosticeret cystisk fibrose.
- Dupilumab-dækning nægtet gennem forsikring eller "Dupixent MyWay-program"
- Patienter, der krævede en nedtrapning af steroider i de foregående 30 dage. Patienter på kroniske steroider mindre eller lig med 20 mg prednison dagligt er dog berettigede.
- Patienter, der var på en anden biologisk medicin i de foregående 3 måneder.
- Patienter med diagnosen EGPA/Churg-Strauss Syndrom
- Gravide patienter
- Patienter med omvendt papilloma vækst
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
CRSwNP participants receiving dupilumab
Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.
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Standardbehandling med dupilumab
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Non-CRSwNP surgical controls
Patients undergoing sinonasal surgery for septal deviation, facial trauma with sinus fracture, cerebrospinal fluid (CSF) rhinorrhea, or sinonasal tumor.
Single tissue collection at the time of surgery.
No dupilumab administered.
No subsequent study visits.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in Sino-Nasal outcome test (SNOT-22) score
Tidsramme: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
Change in sinonasal values from baseline will be assessed using the 22-item Sino-Nasal Outcome Test (SNOT-22).
The SNOT-22 is a 22-item patient questionnaire used to measure symptom severity and related quality of life in people with chronic rhinosinusitis or nasal problems.
Each of the 22 items is measured using a 6-point Likert scale ranging from 0 ("No problem") to 5 ("Worst possible problem"), yielding an overall scoring range of 0-110, such that higher scores are indicative of worsening symptom burden.
This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.
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Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
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Change from baseline in Smell Function
Tidsramme: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
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Change in smell function from baseline will be assessed using the University of Pennsylvania Smell Identification Test (UPSIT).
The UPSIT is a standardized 40-item "scratch-and-sniff" test of olfactory function.
Each participant is provided with four small booklets containing a total of 40 microencapsulated scent strips and is instructed to scratch the strip, sniff the odor, and pick the correct answer from a multiple-choice list of four options per item.
Each correct identification of a scratch-and-sniff odor gives one point, yielding an overall possible scoring range of 1-40.
Lower scores reflect a reduced ability to identify odors.
This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.
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Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
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Change from baseline in Nasal Peak Flow (NPF)
Tidsramme: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
Change in NPF values from baseline will be evaluated in the clinic.
Peak nasal inspiratory flow (PNIF) normal values typically range from 80-180 Liters per minute (L/min) in healthy adults, varying based on age, sex, and physical stature.
Higher values are indicative of greater nasal airway patency.
Change from baseline values will be expressed in units of L/min.
This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.
|
Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in urinary Leukotriene E4 (uLTE₄) levels
Tidsramme: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
Change in uLTE₄ levels from baseline will be assessed in the clinic.
Urine samples will be collected during each specified timepoint, and samples will be processed and analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) or the appropriate immunoassay.
Normal reference ranges for uLTE4 is ≤ 104 picograms per milligram (pg/mg) creatinine.
Elevated uLTE₄ levels are indicative of heightened systemic or airway cysteinyl leukotriene activity and serve as a reliable, non-invasive biomarker for several inflammatory, respiratory, and hypersensitivity disorders.
Change from baseline values will be expressed in units of pg/mg.
This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.
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Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
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Change from Baseline in Absolute Peripheral Blood Eosinophil Count
Tidsramme: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
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Changes in Absolute Eosinophil Count from peripheral blood from baseline will be assessed in the clinic.
Blood samples will be drawn during each prespecified timepoint and analyzed using automated hematology analyzers or manual microscopy as part of a Complete Blood Count (CBC) with differential.
Absolute Eosinophil Counts (AEC) vary by laboratory but are generally in the range of 0-500 cells per microliter (cells/µL) of blood.
Elevated AEC in peripheral blood is indicative of increased in eosinophilic conditions as evident from rashes, worsening pulmonary symptoms and/or neuropathy.
Change from baseline values will be expressed in cells/uL.
This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.
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Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
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Change from Baseline in Serum Total Immunoglobulin E (IgE) Levels
Tidsramme: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
Changes in total serum IgE levels from baseline will be assessed in the clinic.
Blood samples will be drawn during each prespecified timepoint and analyzed using automated immunoassay techniques to measure the concentration of circulating IgE.
Standard reference ranges vary by laboratory assay, age, and individual baseline factors but are generally in the range of 0-100 International Units per milliliter (IU/mL) of blood.
Elevated IGe concentrations can be indicative of a number of clinical indications including atopic and allergic diseases.
Change from baseline values will be expressed in IU/mL.
This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.
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Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Golda Hudes, MD, Montefiore Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Effect of 16-week Dupilumab Treatment on Sinonasal Respiratory Symptoms and Sense of Smell in Ethnically Diverse Patients with Chronic Rhinosinusitis with Nasal Polyposis
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. februar 2022
Primær færdiggørelse (Anslået)
1. august 2027
Studieafslutning (Anslået)
1. august 2027
Datoer for studieregistrering
Først indsendt
26. januar 2022
Først indsendt, der opfyldte QC-kriterier
8. februar 2022
Først opslået (Faktiske)
18. februar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021-13161
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .