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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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. 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Angela Donaldson, M.D.

Contact us for the latest status

Contact information:

Angela Donaldson M.D.

(904)953-6778

Donaldson.Angela@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Michael Marino, M.D.

Contact us for the latest status

Contact information:

Devyani Lal M.D.

Lal.Devyani@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20482118

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