Scientific Articles

Chronic rhinosinusitis: budesonide and nasal irrigation

Chronic rhinosinusitis: addition of budesonide improves the efficacy of low-pressure, high-volume nasal irrigation

The addition of budesonide to nasal irrigation low-pressure, high-volume of saline could improveoutcome in patients with chronic rhinosinusitis (CRS), according to the results of a study recently published in JAMA Otolaryngology-Head & Neck Surgery and conducted by Washington University School of Medicine in St Louis.

Objectives of the study

The research team evaluated the incremental effect ofadding budesonide to low-pressure, high-volume salinenasal irrigation. This randomized double-blind, placebo-controlled clinical trial was conducted at the academic medical center between January 1, 2016 and February 16, 2017. A total of 80 adult patients with chronic rhinosinusitis were enrolled; 74 completed baseline assessments; and 61 remained in the trial to complete all analyses. Data analysis was conducted from March 2017 to August 2017.

Mode

All study participants were provided with nasal irrigation kits that included capsules containing budesonide (treatment group) or lactose (control group). Patients were asked to dissolve the capsules in the saline solution and use the resulting solution to irrigate both nasal cavities, using half of the solution for each cavityonce a day for 30 days..

NASIR®Nasal Irrigation System

The primaryoutcome measure was the change in Sino-Nasal Outcome Test (SNOT-22) scores from pre-treatment to post-treatment in the budesonide group compared with the control group. Secondary outcome measures included patient-reported response to treatment as measured by a modification of the Clinical Global Impression (CGI) scale and endoscopic examination obtained from the Lund-Kennedy grading system.

Results

Of the 74 participants who completed baseline assessments (37 in each branch of the study), mean (SD) age, 51 (14.7) years, 50 (68%) were women. Of the 61 who remained in the trial to complete all analyses, 29 were randomized to budesonide treatment and 32 to saline alone. The mean change in SNOT-22 scores was 20.7 points for those in the budesonide group and 13.6 points for those in the control group, for a mean difference of 7 points in favor of the budesonide group (95% CI, -2 to 16).

A total of 23 participants (79%) in the budesonide group experienced a clinically significant reduction in SNOT-22 scores compared with 19 (59%) in the control group, for a difference of 20% (95% CI, -2.5% to 42.5%). The mean change in endoscopic scores was 3.4 points for the budesonide group and 2.7 points for the control group. There were no related adverse events.

Conclusions

This study shows that budesonide in nasal irrigation with saline produces clinically significant benefits over and above the benefits of saline alone for patients with chronic rhinosinusitis.

Article: Tait S et al. Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. doi:10.1001/jamaoto.2018.0667; Published online June 7, 2018.