Short-term high-dose budesonide nasal spray for postoperative uncontrolled chronic rhinosinusitis: A randomized controlled trial

Background:The goal of treatments for chronic rhinosinusitis (CRS) is to achieve and maintain clinical control.However, more than 40% of patients showed uncontrolled disease after endoscopic sinus surgery (ESS).To date, research guidance on optimal dosing regimens for intranasal corticosteroid spray (INCS) in uncontrolled CRS remains limited.Methods: This prospective, randomized controlled trial enrolled 43 patients with uncontrolled CRS 6 months post-ESS.Participants received either high-dose (1024 g/day) or control-dose (256 g/day) budesonide nasal spray for 14 days in a non-blinded manner.Outcomes included symptom scores (TNSS, VAS), quality of life (SNOT-22), endoscopic findings.We also explored the subgroup analyses by comparing eosinophilic (ECRS) and non-eosinophilic CRS (NECRS).Intention-to-treat (ITT) analysis was used in this clinical trial. Results:The study recruited 43 patients (high-dose group = 21, control group = 22).The high-dose group exhibited significantly greater reductions in TNSS, endoscopic E score, and Lund-Kennedy score (P < 0.05), and improved nasal obstruction VAS (P = 0.027).Subgroup analysis revealed superior efficacy in ECRS patients (endoscopic score reduction: P < 0.05).Adverse events were mild and comparable between groups (high-dose group 2/21 [9.5%] vs.Control group 1/22 [4.5%], P > 0.05).Conclusions: Short-term high-dose budesonide nasal spray is effective and safe for postoperative uncontrolled CRS, particularly in ECRS, offering a rapid therapeutic alternative.