The role of nasal corticosteroid irrigation on preoperative control of chronic rhinosinusitis: randomized clinical trial

• Grant number: 21/00973-5
• Support Opportunities: Regular Research Grants
• Start date: July 01, 2021
• End date: June 30, 2023
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Eduardo Macoto Kosugi
• Grantee: Eduardo Macoto Kosugi
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

The goal of the chronic rhinosinusitis (CRS) treatment is the control of disease, that must be reached with surgical treatment and, at most, intranasal corticosteroids (CS). Currently, endoscopic sinus surgery (ESS) and high-volume CS nasal irrigation (HVCSNI) are considered the best choice to reach the control of CRS. However, ESS could not be performed soon due to medical or socioeconomic issues, like surgery waiting lines. Even in non-operated CRS patients, nasal irrigation presented more sinus penetration than nasal sprays, however, preoperative HVCSNI usage is considered option, whereas CS spray has strength of recommendation. HVCSNI superiority over CS spray must be tested in CRS patients without previous ESS. Objectives: To assess HVCSNI superiority over CS spray in non-operated CRS patients and to assess HVCSNI capability to reduce or postpone surgical need and to prevent CRS exacerbations. Methods: A double-blinded randomized clinical trial with non-operated CRS patients who failed routine initial medical therapy (CS spray 400µg per day and nasal saline irrigation for 3 months) and needed surgical intervention. These patients will be randomized to receive 1000µg budesonide per day for 3 months in one of two different ways: CE irrigation + Placebo spray or Placebo irrigation + CE spray). (AU)