A Study to Evaluate the Effect of Medical Intervention on Sinonasal Inflammation in Patients with Chronic Sinusitis, Nasal Polyps and Positive Sinus Culture

Overview

Información sobre este estudio

The purpose of this study is to compare change in SNOT-22 score in patients who received medication therapy such as oral antibiotics, topical antibiotics, oral corticosteroids, topical corticosteroids, leukotriene receptor antagonist, and interleukin 5 receptor antagonist following endoscopic sinus surgery versus control in patient with chronic sinusitis with nasal polyps and a positive culture.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Patients 18 years old or older.
  • Patients that meet indications for chronic rhinosinusitis based on American Academy of Otolaryngology Head and Neck Surgery clinical practice consensus.
  • Patients should have twelve weeks are more of mucopurulent drainage, nasal congestion, facial pain and pressure, or reduction of smell, and inflammation documented by purulent mucus or edema within the middle meatus or anterior ethmoid region or radiographic findings of inflammation within the paranasal sinuses.
  • All patients most have endoscopic evidence of nasal polyps.
  • All patients must have a culture from the middle meatus, maxillary, ethmoid, sphenoid, or frontal sinus which is positive.

Exclusion Criteria: 

  • Patients with Cystic Fibrosis, Primary Ciliary Dyskinesia, history of immunodeficiency, Sarcoidosis, vasculitis disorders such as granulomatosis with polyangiitis and eosinophilic granulomatosis with polyangiitis.
  • Patients with a history of allergic reaction to Singulair (montelukast) or drug intolerance.
  • Patients that received oral corticosteroids within two weeks of 6 month follow up.
  • Patients who did not complete a pre-operative and post-operative SNOT-22 and modified Lund-Kennedy score 6 months after their surgery.
  • Patients if they do not meet criteria for chronic rhinosinusitis with nasal polyps based on the AAO-HNS clinical practice consensus statement.
  • Patients without a history of positive culture are excluded.
  • Patients age less than 18 years old. 

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Angela Donaldson, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Angela Donaldson M.D.

(904)953-6778

Donaldson.Angela@mayo.edu

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Michael Marino, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Devyani Lal M.D.

Lal.Devyani@mayo.edu

More information

Publicaciones

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