Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis · Nasal Polyps
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 4
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 504 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. The development of biologic medications over the last 5 years has revolutionized the treatment of CRSwNP. Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab. However, data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for patients in these trials. The result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. It is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Age \> 18 years
- Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria
- Bilateral nasal polyposis visible on sinonasal endoscopy
- Nasal polyp score \> 5
- Baseline SNOT-22 total score \> 30
- Patient elects biologic therapy for the management of CRSwNP
- Capable of receiving all 3 biologic therapy medications.
- Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit.
Exclusion Criteria:
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Endoscopic sinus surgery within 6-months preceding enrollment / randomization.
- Oral corticosteroid use within 30-days preceding enrollment / randomization.
- Serum IgE level outside the dosing range for omalizumab (i.e., \<30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)
- Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.
- Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization.
- Any previous treatment with any of the 3 biologic medications.
- Comorbid cystic fibrosis, CVID, or ciliary dyskinesia.
- Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Dupilumab
No informado en este registro.
Biological: Biologic Agents
Omalizumab
No informado en este registro.
Biological: Biologic Agents
Mepolizumab
No informado en este registro.
Biological: Biologic Agents
Biologic Agents BIOLOGICAL
Evidence by way of phase III clinical trials has shown efficacy of dupilumab, omalizumab, and mepolizumab to placebo, leading to regulatory approval and widespread clinical use. However, data from these clinical trials does not show universal improvement and ideal control of disease across all patients with Chronic Sinusitis with Nasal Polyps (CRSwNP). Successful completion of this trial will help answer some of the most pressing clinical questions related to biologics and CRSwNP. Specifically, findings will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Disease-Specific Quality of Life
Plazo: 24 weeks
The 22-item SinoNasal Outcome Test (SNOT-22; ©2006, Washington University, St. Louis, MO) will serve as the primary outcome of interest for all study aims/objectives. The SNOT-22 survey is a CRS-specific QOL instrument containing 22 questions (total summarized score range: 0-110) with high internal consistency and high test-retest reliability. The SNOT-22 utilizes Likert scales numbering from 0 ("No problem") to 5 "Problem as bad as it can be"). The SNOT-22 has been shown to discriminate between subjects with CRS and healthy controls, as well as identify significant differences after both medical and surgical treatments.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (5)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
5 centros
Mayo Clinic ArizonaPhoenix, Arizona, United StatesReclutando
UF Health ENT and Allergy - The OaksGainesville, Florida, United StatesReclutando
Oregon Health and Science UniversityPortland, Oregon, United StatesReclutando
Medical University of South CarolinaCharleston, South Carolina, United StatesReclutando
Vanderbilt University Medical CenterNashville, Tennessee, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Medical University of South Carolina
- Inicio del estudio
- 3 jun 2026 Real
- Finalización primaria
- 2030-02 Estimado
- Finalización del estudio
- 2030-02 Estimado
- Primera publicación
- 13 feb 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026