Effect of Budesonide Nasal Irrigation in Patients With Chronic Rhinosinusitis With Nasal Polyps Without Prior Sinus Surgery: A Randomized, Double-Blind, Placebo-Controlled Study.

BACKGROUND

The indication for nasal irrigation with corticosteroids after sinus surgery in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is well established, as surgery facilitates distribution throughout the sinonasal cavity. However, it remains unknown whether this approach could also provide therapeutic benefit prior to surgery. This study aims to compare the effect of budesonide versus saline nasal irrigation in surgically naive CRSwNP patients.

METHODS

A randomized, double-blind, placebo-controlled parallel-group study was conducted in 52 patients with diffuse type 2 CRSwNP with no previous sinus surgery. Patients were randomized to receive either 1 mg budesonide or saline nasal irrigation twice daily for four weeks. The primary outcome was the change in the 22-item Sinonasal Outcome Test (SNOT-22). Secondary outcomes included the Visual Analogue Scale (VAS), Nasal Polyp Score (NPS), and the Connecticut (CCCRC) olfactory test.

RESULTS

A total of 52 patients were randomized (mean age 50.1 ± 12.9 years; 51.9% female). The intention-to-treat (ITT) analysis showed that the budesonide nasal irrigation group demonstrated a significantly greater improvement in SNOT-22 (mean difference: 18.1 points [95% CI: 3.4 to 32.8; p = 0.017]), VAS (mean difference 2.24 points [95% CI: 0.35 to 4.13; p = 0.018]) and NPS (mean difference: 0.73 points [95% CI: 0.25 to 1.21]; p = 0.003). No significant differences were observed between groups in CCCRC.

CONCLUSION

Budesonide nasal irrigation may be an important tool for controlling sinonasal symptoms in patients with CRSwNP who are not candidates for sinus surgery or while awaiting surgical treatment.