Abstract
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 μg/day) or control-dose (256 μg/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.