Efeitos do tratamento com dupilumabe em uma população etnicamente diversa com rinossinusite crônica com polipose nasal (CRSwNP)
9 de setembro de 2026 atualizado por: Montefiore Medical Center
Efeitos do tratamento com dupilumabe em uma população etnicamente diversa com rinossinusite crônica com polipose nasal (CRSwNP)
A hipótese central deste estudo é que a adição do tratamento com dupilumabe aos corticosteróides intranasais padrão melhorará as medidas relatadas pelo paciente sobre a atividade da doença e o olfato em uma coorte de pacientes de minorias étnicas e raciais com RSCcPN
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
Primeiro, confirmará a eficácia do dupilumabe no tratamento da RSCcPN em pacientes de minorias étnicas e raciais que tradicionalmente têm sido sub-representados nos ensaios clínicos existentes de produtos biológicos na RSCcPN Em segundo lugar, esta pesquisa estabelecerá um biomarcador de resposta terapêutica ao dupilumabe identificando o efeito biológico do dupilumabe em pacientes com RSCcPN e sua associação com a melhora dos sintomas.
Finalmente, os investigadores medirão o efeito do dupilumabe nos sintomas da asma e na função pulmonar em pacientes com RSCcPN e asma comórbida.
Haverá uma visita de triagem, seguida de uma visita inicial onde o medicamento será administrado. As visitas de acompanhamento serão agendadas em 2 semanas e, em seguida, 16 semanas a partir da linha de base. As visitas de longo prazo ocorrerão em 36 e 52 semanas.
Tipo de estudo
Observacional
Inscrição (Real)
60
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
New York
-
The Bronx, New York, Estados Unidos, 10461
- Montefiore Medical Center
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 99 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
60 pacientes com RSCcPN diagnosticados por médicos, com ou sem asma comórbida que atendem aos critérios de indicação para uso de Dupilumabe aprovado pela FDA.
Esses pacientes terão 18 anos ou mais e terão seguro que permite cobertura de Dupilumabe ou cobertura de Dupilumabe obtida por meio do "Programa Dupixent MyWay"
Descrição
Critério de inclusão:
- Pacientes com RSCcPN diagnosticados por médicos, com ou sem asma comórbida que atendem aos critérios de indicação para uso de Dupilumabe aprovado pela FDA.
- Pacientes com idade igual ou superior a 18 anos.
- Paciente disposto a fornecer consentimento para ser um participante do estudo.
- Doentes com seguro que permite cobertura de Dupilumab ou cobertura de Dupilumab obtida através do "Dupixent MyWay Program"
Critério de exclusão:
- Idade inferior a 18 anos
- Suspeita ou diagnóstico de rinossinusite fúngica alérgica.
- Fibrose cística suspeita ou diagnosticada.
- Cobertura de dupilumabe negada por meio de seguro ou "Programa Dupixent MyWay"
- Pacientes que necessitaram de redução gradual de esteroides nos 30 dias anteriores. No entanto, pacientes em uso crônico de esteroides menores ou iguais a 20 mg de prednisona diariamente são elegíveis.
- Pacientes que estavam tomando um medicamento biológico diferente nos últimos 3 meses.
- Pacientes com diagnóstico de EGPA/Síndrome de Churg-Strauss
- pacientes grávidas
- Pacientes com crescimento de papiloma invertido
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
CRSwNP participants receiving dupilumab
Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.
|
Tratamento padrão de cuidados com dupilumabe
|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in Sino-Nasal outcome test (SNOT-22) score
Prazo: 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.
|
Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
|
Change from baseline in Smell Function
Prazo: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
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.
|
Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
|
Change from baseline in Nasal Peak Flow (NPF)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in urinary Leukotriene E4 (uLTE₄) levels
Prazo: 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.
|
Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
|
Change from Baseline in Absolute Peripheral Blood Eosinophil Count
Prazo: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
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.
|
Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
|
Change from Baseline in Serum Total Immunoglobulin E (IgE) Levels
Prazo: 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.
|
Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Golda Hudes, MD, Montefiore Medical Center
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Van Zele T, Gevaert P, Watelet JB, Claeys G, Holtappels G, Claeys C, van Cauwenberge P, Bachert C. Staphylococcus aureus colonization and IgE antibody formation to enterotoxins is increased in nasal polyposis. J Allergy Clin Immunol. 2004 Oct;114(4):981-3. doi: 10.1016/j.jaci.2004.07.013. No abstract available.
- Orlandi RR, Kingdom TT, Hwang PH, Smith TL, Alt JA, Baroody FM, Batra PS, Bernal-Sprekelsen M, Bhattacharyya N, Chandra RK, Chiu A, Citardi MJ, Cohen NA, DelGaudio J, Desrosiers M, Dhong HJ, Douglas R, Ferguson B, Fokkens WJ, Georgalas C, Goldberg A, Gosepath J, Hamilos DL, Han JK, Harvey R, Hellings P, Hopkins C, Jankowski R, Javer AR, Kern R, Kountakis S, Kowalski ML, Lane A, Lanza DC, Lebowitz R, Lee HM, Lin SY, Lund V, Luong A, Mann W, Marple BF, McMains KC, Metson R, Naclerio R, Nayak JV, Otori N, Palmer JN, Parikh SR, Passali D, Peters A, Piccirillo J, Poetker DM, Psaltis AJ, Ramadan HH, Ramakrishnan VR, Riechelmann H, Roh HJ, Rudmik L, Sacks R, Schlosser RJ, Senior BA, Sindwani R, Stankiewicz JA, Stewart M, Tan BK, Toskala E, Voegels R, Wang de Y, Weitzel EK, Wise S, Woodworth BA, Wormald PJ, Wright ED, Zhou B, Kennedy DW. International Consensus Statement on Allergy and Rhinology: Rhinosinusitis. Int Forum Allergy Rhinol. 2016 Feb;6 Suppl 1:S22-209. doi: 10.1002/alr.21695.
- Patou J, Gevaert P, Van Zele T, Holtappels G, van Cauwenberge P, Bachert C. Staphylococcus aureus enterotoxin B, protein A, and lipoteichoic acid stimulations in nasal polyps. J Allergy Clin Immunol. 2008 Jan;121(1):110-5. doi: 10.1016/j.jaci.2007.08.059. Epub 2007 Nov 5.
- Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, Hellings P, Jiao L, Wang L, Evans RR, Pirozzi G, Graham NM, Swanson B, Hamilton JD, Radin A, Gandhi NA, Stahl N, Yancopoulos GD, Sutherland ER. Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):469-79. doi: 10.1001/jama.2015.19330.
- Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, Busse WW, Ford L, Sher L, FitzGerald JM, Katelaris C, Tohda Y, Zhang B, Staudinger H, Pirozzi G, Amin N, Ruddy M, Akinlade B, Khan A, Chao J, Martincova R, Graham NMH, Hamilton JD, Swanson BN, Stahl N, Yancopoulos GD, Teper A. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018 Jun 28;378(26):2486-2496. doi: 10.1056/NEJMoa1804092. Epub 2018 May 21.
- Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, Mullol J, Greos LS, Bosso JV, Laidlaw TM, Cervin AU, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1. Epub 2019 Sep 19.
- Fokkens W, Desrosiers M, Harvey R, Hopkins C, Mullol J, Philpott C, Alobid I, Anselmo-Lima WT, Bachert C, Baroody F, Bernal-Sprekelsen M, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Douglas R, Gevaert P, Hafner A, Hellings P, Joos G, Kalogjera L, Kern R, Knill A, Kocks J, Landis BN, Limpens J, Lebeer S, Lourenco O, Matricardi PM, Meco C, O Mahony L, Reitsma S, Ryan D, Schlosser R, Senior B, Smith T, Teeling T, Tomazic PV, Toppila-Salmi S, Wang DY, Wang D, Zhang L, Lund V. EPOS2020: development strategy and goals for the latest European Position Paper on Rhinosinusitis. Rhinology. 2019 Jun 1;57(3):162-168. doi: 10.4193/Rhin19.080.
- Gevaert P, Omachi TA, Corren J, Mullol J, Han J, Lee SE, Kaufman D, Ligueros-Saylan M, Howard M, Zhu R, Owen R, Wong K, Islam L, Bachert C. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020 Sep;146(3):595-605. doi: 10.1016/j.jaci.2020.05.032. Epub 2020 Jun 7.
- Bachert C, Hellings PW, Mullol J, Naclerio RM, Chao J, Amin N, Grabher A, Swanson BN, Hamilton JD, Guillonneau S, Taniou C, Zhang D, Pirozzi G, Graham NMH, Staudinger H, Mannent LP, Khan A. Dupilumab improves patient-reported outcomes in patients with chronic rhinosinusitis with nasal polyps and comorbid asthma. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2447-2449.e2. doi: 10.1016/j.jaip.2019.03.023. Epub 2019 Mar 27. No abstract available.
- Maspero JF, Katelaris CH, Busse WW, Castro M, Corren J, Chipps BE, Peters AT, Pavord ID, Ford LB, Sher L, Rabe KF, Rice MS, Rowe P, Lu Y, Harel S, Jagerschmidt A, Khan AH, Kamat S, Pirozzi G, Amin N, Ruddy M, Graham NMH, Mannent LP, Teper A. Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2020 Feb;8(2):527-539.e9. doi: 10.1016/j.jaip.2019.07.016. Epub 2019 Jul 24.
- Cardell LO, Stjarne P, Jonstam K, Bachert C. Endotypes of chronic rhinosinusitis: Impact on management. J Allergy Clin Immunol. 2020 Mar;145(3):752-756. doi: 10.1016/j.jaci.2020.01.019. Epub 2020 Jan 28.
- Mahdavinia M, Benhammuda M, Codispoti CD, Tobin MC, Losavio PS, Mehta A, Jeffe JS, Bandi S, Peters AT, Stevens WW, Landay A, Keshavarzian A, Schleimer RP, Batra PS. African American Patients with Chronic Rhinosinusitis Have a Distinct Phenotype of Polyposis Associated with Increased Asthma Hospitalization. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):658-664.e1. doi: 10.1016/j.jaip.2015.11.031. Epub 2016 Jan 20.
- Borish L, Chipps B, Deniz Y, Gujrathi S, Zheng B, Dolan CM; TENOR Study Group. Total serum IgE levels in a large cohort of patients with severe or difficult-to-treat asthma. Ann Allergy Asthma Immunol. 2005 Sep;95(3):247-53. doi: 10.1016/S1081-1206(10)61221-5.
- Vergara C, Murray T, Rafaels N, Lewis R, Campbell M, Foster C, Gao L, Faruque M, Oliveira RR, Carvalho E, Araujo MI, Cruz AA, Watson H, Mercado D, Knight-Madden J, Ruczinski I, Dunston G, Ford J, Caraballo L, Beaty TH, Mathias RA, Barnes KC. African ancestry is a risk factor for asthma and high total IgE levels in African admixed populations. Genet Epidemiol. 2013 May;37(4):393-401. doi: 10.1002/gepi.21702. Epub 2013 Apr 2.
- Nyenhuis SM, Krishnan JA, Berry A, Calhoun WJ, Chinchilli VM, Engle L, Grossman N, Holguin F, Israel E, Kittles RA, Kraft M, Lazarus SC, Lehman EB, Mauger DT, Moy JN, Peters SP, Phipatanakul W, Smith LJ, Sumino K, Szefler SJ, Wechsler ME, Wenzel S, White SR, Ackerman SJ. Race is associated with differences in airway inflammation in patients with asthma. J Allergy Clin Immunol. 2017 Jul;140(1):257-265.e11. doi: 10.1016/j.jaci.2016.10.024. Epub 2017 Jan 6.
- Fitzpatrick AM, Gillespie SE, Mauger DT, Phillips BR, Bleecker ER, Israel E, Meyers DA, Moore WC, Sorkness RL, Wenzel SE, Bacharier LB, Castro M, Denlinger LC, Erzurum SC, Fahy JV, Gaston BM, Jarjour NN, Larkin A, Levy BD, Ly NP, Ortega VE, Peters SP, Phipatanakul W, Ramratnam S, Teague WG. Racial disparities in asthma-related health care use in the National Heart, Lung, and Blood Institute's Severe Asthma Research Program. J Allergy Clin Immunol. 2019 Jun;143(6):2052-2061. doi: 10.1016/j.jaci.2018.11.022. Epub 2019 Jan 8.
- Matsui EC, Adamson AS, Peng RD. Time's up to adopt a biopsychosocial model to address racial and ethnic disparities in asthma outcomes. J Allergy Clin Immunol. 2019 Jun;143(6):2024-2025. doi: 10.1016/j.jaci.2019.03.015. Epub 2019 Mar 30. No abstract available.
- Pino-Yanes M, Thakur N, Gignoux CR, Galanter JM, Roth LA, Eng C, Nishimura KK, Oh SS, Vora H, Huntsman S, Nguyen EA, Hu D, Drake KA, Conti DV, Moreno-Estrada A, Sandoval K, Winkler CA, Borrell LN, Lurmann F, Islam TS, Davis A, Farber HJ, Meade K, Avila PC, Serebrisky D, Bibbins-Domingo K, Lenoir MA, Ford JG, Brigino-Buenaventura E, Rodriguez-Cintron W, Thyne SM, Sen S, Rodriguez-Santana JR, Bustamante CD, Williams LK, Gilliland FD, Gauderman WJ, Kumar R, Torgerson DG, Burchard EG. Genetic ancestry influences asthma susceptibility and lung function among Latinos. J Allergy Clin Immunol. 2015 Jan;135(1):228-35. doi: 10.1016/j.jaci.2014.07.053. Epub 2014 Oct 6.
- Salari K, Burchard EG. Latino populations: a unique opportunity for epidemiological research of asthma. Paediatr Perinat Epidemiol. 2007 Nov;21 Suppl 3:15-22. doi: 10.1111/j.1365-3016.2007.00880.x.
- Jerschow E, Edin ML, Pelletier T, Abuzeid WM, Akbar NA, Gibber M, Fried M, Lih FB, Gruzdev A, Bradbury JA, Han W, Hudes G, Keskin T, Schuster VL, Spivack S, Zeldin DC, Rosenstreich D. Plasma 15-Hydroxyeicosatetraenoic Acid Predicts Treatment Outcomes in Aspirin-Exacerbated Respiratory Disease. J Allergy Clin Immunol Pract. 2017 Jul-Aug;5(4):998-1007.e2. doi: 10.1016/j.jaip.2016.11.021. Epub 2017 Jan 31.
- Jerschow E, Edin ML, Chi Y, Hurst B, Abuzeid WM, Akbar NA, Gibber M, Fried MP, Han W, Pelletier T, Ren Z, Keskin T, Roizen G, Lih FB, Gruzdev A, Bradbury JA, Schuster V, Spivack S, Rosenstreich D, Zeldin DC. Sinus Surgery Is Associated with a Decrease in Aspirin-Induced Reaction Severity in Patients with Aspirin Exacerbated Respiratory Disease. J Allergy Clin Immunol Pract. 2019 May-Jun;7(5):1580-1588. doi: 10.1016/j.jaip.2018.12.014. Epub 2018 Dec 21.
- Shah SJ, Abuzeid WM, Ponduri A, Pelletier T, Ren Z, Keskin T, Roizen G, Rosenstreich D, Ferastraoaru D, Jerschow E. Endoscopic sinus surgery improves aspirin treatment response in aspirin-exacerbated respiratory disease patients. Int Forum Allergy Rhinol. 2019 Dec;9(12):1401-1408. doi: 10.1002/alr.22418. Epub 2019 Sep 30.
- Higashi N, Taniguchi M, Mita H, Yamaguchi H, Ono E, Akiyama K. Aspirin-intolerant asthma (AIA) assessment using the urinary biomarkers, leukotriene E4 (LTE4) and prostaglandin D2 (PGD2) metabolites. Allergol Int. 2012 Sep;61(3):393-403. doi: 10.2332/allergolint.11-RA-0403. Epub 2012 May 25.
- Kim JE, Kountakis SE. The prevalence of Samter's triad in patients undergoing functional endoscopic sinus surgery. Ear Nose Throat J. 2007 Jul;86(7):396-9.
- McMains KC, Kountakis SE. Medical and surgical considerations in patients with Samter's triad. Am J Rhinol. 2006 Nov-Dec;20(6):573-6. doi: 10.2500/ajr.2006.20.2913.
- Buchheit KM, Hulse KE. Local immunoglobulin production in nasal tissues: A key to pathogenesis in chronic rhinosinusitis with nasal polyps and aspirin-exacerbated respiratory disease. Ann Allergy Asthma Immunol. 2021 Feb;126(2):127-134. doi: 10.1016/j.anai.2020.09.016. Epub 2020 Oct 13.
- Higashi N, Mita H, Ono E, Fukutomi Y, Yamaguchi H, Kajiwara K, Tanimoto H, Sekiya K, Akiyama K, Taniguchi M. Profile of eicosanoid generation in aspirin-intolerant asthma and anaphylaxis assessed by new biomarkers. J Allergy Clin Immunol. 2010 May;125(5):1084-1091.e6. doi: 10.1016/j.jaci.2009.12.977. Epub 2010 Mar 20.
- Higashi N, Mita H, Yamaguchi H, Fukutomi Y, Akiyama K, Taniguchi M. Urinary tetranor-PGDM concentrations in aspirin-intolerant asthma and anaphylaxis. J Allergy Clin Immunol. 2012 Feb;129(2):557-9, 559.e1-2. doi: 10.1016/j.jaci.2011.09.019. Epub 2011 Oct 22. No abstract available.
- Hayes SM, Biggs TC, Goldie SP, Harries PG, Walls AF, Allan RN, Pender SLF, Salib RJ. Staphylococcus aureus internalization in mast cells in nasal polyps: Characterization of interactions and potential mechanisms. J Allergy Clin Immunol. 2020 Jan;145(1):147-159. doi: 10.1016/j.jaci.2019.06.013. Epub 2019 Jun 27.
- Takeda K, Sakakibara S, Yamashita K, Motooka D, Nakamura S, El Hussien MA, Katayama J, Maeda Y, Nakata M, Hamada S, Standley DM, Hayama M, Shikina T, Inohara H, Kikutani H. Allergic conversion of protective mucosal immunity against nasal bacteria in patients with chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol. 2019 Mar;143(3):1163-1175.e15. doi: 10.1016/j.jaci.2018.07.006. Epub 2018 Jul 25.
- Corriveau MN, Zhang N, Holtappels G, Van Roy N, Bachert C. Detection of Staphylococcus aureus in nasal tissue with peptide nucleic acid-fluorescence in situ hybridization. Am J Rhinol Allergy. 2009 Sep-Oct;23(5):461-5. doi: 10.2500/ajra.2009.23.3367.
- Perez-Novo CA, Kowalski ML, Kuna P, Ptasinska A, Holtappels G, van Cauwenberge P, Gevaert P, Johannson S, Bachert C. Aspirin sensitivity and IgE antibodies to Staphylococcus aureus enterotoxins in nasal polyposis: studies on the relationship. Int Arch Allergy Immunol. 2004 Mar;133(3):255-60. doi: 10.1159/000076832. Epub 2004 Feb 17.
- Suh YJ, Yoon SH, Sampson AP, Kim HJ, Kim SH, Nahm DH, Suh CH, Park HS. Specific immunoglobulin E for staphylococcal enterotoxins in nasal polyps from patients with aspirin-intolerant asthma. Clin Exp Allergy. 2004 Aug;34(8):1270-5. doi: 10.1111/j.1365-2222.2004.02051.x.
- Bachert C, Maurer M, Palomares O, Busse WW. What is the contribution of IgE to nasal polyposis? J Allergy Clin Immunol. 2021 Jun;147(6):1997-2008. doi: 10.1016/j.jaci.2021.03.016. Epub 2021 Mar 20.
- Huang GX, Palumbo ML, Singer JI, Cahill KN, Laidlaw TM. Sinus surgery improves lower respiratory tract reactivity during aspirin desensitization for AERD. J Allergy Clin Immunol Pract. 2019 May-Jun;7(5):1647-1649. doi: 10.1016/j.jaip.2019.02.037. Epub 2019 Mar 12. No abstract available.
- Bergmark RW, Palumbo M, Rahman S, Maurer R, Dominas C, Roditi R, Bhattacharyya N, Maxfield A, Buchheit KM, Laidlaw TM. Aspirin-Exacerbated Respiratory Disease: Association Between Patient-Reported Sinus and Asthma Morbidity. J Allergy Clin Immunol Pract. 2021 Apr;9(4):1604-1611. doi: 10.1016/j.jaip.2020.11.051. Epub 2020 Dec 8.
- Hayworth JL, Mazzuca DM, Maleki Vareki S, Welch I, McCormick JK, Haeryfar SM. CD1d-independent activation of mouse and human iNKT cells by bacterial superantigens. Immunol Cell Biol. 2012 Aug;90(7):699-709. doi: 10.1038/icb.2011.90. Epub 2011 Nov 1.
- Ziegler C, Goldmann O, Hobeika E, Geffers R, Peters G, Medina E. The dynamics of T cells during persistent Staphylococcus aureus infection: from antigen-reactivity to in vivo anergy. EMBO Mol Med. 2011 Nov;3(11):652-66. doi: 10.1002/emmm.201100173. Epub 2011 Sep 2.
- Meltzer EO, Orgel HA, Rogenes PR, Field EA. Nasal cytology in patients with allergic rhinitis: effects of intranasal fluticasone propionate. J Allergy Clin Immunol. 1994 Oct;94(4):708-15. doi: 10.1016/0091-6749(94)90178-3.
- Thornton MA, Walshe P, Costello RW, McConn-Walsh R, Walsh MA. An alternative technique for nasal biopsy. Laryngoscope. 2004 Jun;114(6):1060-2. doi: 10.1097/00005537-200406000-00019.
- Effect of 16-week Dupilumab Treatment on Sinonasal Respiratory Symptoms and Sense of Smell in Ethnically Diverse Patients with Chronic Rhinosinusitis with Nasal Polyposis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de fevereiro de 2022
Conclusão Primária (Estimado)
1 de agosto de 2027
Conclusão do estudo (Estimado)
1 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
26 de janeiro de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de fevereiro de 2022
Primeira postagem (Real)
18 de fevereiro de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2021-13161
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .