Tait S, et al. - Experts assessed the incremental impact of adding budesonide to large-volume, low-pressure saline sinus irrigation for chronic rhinosinusitis (CRS). In patients with CRS, clinically meaningful benefits beyond the benefits of saline alone were achieved with budesonide in saline nasal lavage.

Methods

• Authors conducted this double-blind, placebo-controlled, randomized clinical trial at a quaternary care academic medical center between January 1, 2016, and February 16, 2017.
• They enrolled a total of 80 adult patients with CRS; 74 completed baseline assessments; and 61 remained in the trial to complete all analyses.
• They conducted data analysis from March 2017 to August 2017.
• A sinus rinse kit including saline and identical-appearing capsules that contained either budesonide (treatment group) or lactose (control group) was provided to all study participants.
• Researchers instructed the patients to dissolve the capsules in the saline and use the resulting solution to irrigate both nasal cavities, using half the solution for each cavity, once daily for 30 days.
• The change in Sino-Nasal Outcome Test (SNOT-22) scores, pretreatment to posttreatment, in the budesonide group compared with the control group were the primary outcome measure.
• Patient-reported response to treatment, as measured with a modification of the Clinical Global Impressions scale, and endoscopic examination scored by the Lund-Kennedy grading system were secondary outcome measures.

Results

• As per data, out of the 74 participants who completed baseline assessments (37 in each study arm), mean (SD) age, 51 (14.7) years, 50 (68%) were women.
• Findings suggested that of the 61 who remained in the trial to complete all analyses, 29 were randomized to budesonide treatment, and 32 to saline alone.
• Results demonstrated that the 20.7 points was average change in SNOT-22 scores 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 clinically meaningful reduction in their SNOT-22 scores was experienced by a total of 23 participants (79%) in the budesonide group vs 19 (59%) in the control group, for a difference of 20% (95% CI, -2.5% to 42.5%).
• Authors noted that 3.4 points was the average change in endoscopic scores for the budesonide group and 2.7 points for the control group.
• They did not note any related adverse events.