Synopsis: This 52-week, phase 3, randomized, double-blind, parallel-group trial compared the efficacy and safety of twice-daily inhaled triple therapy with budesonide at 2 different doses (160 and 320-μg) plus a LAMA (18-μg of glycopyrrolate) and a LABA (9.6-μg of formoterol) in comparison with either glycopyrrolate-formoterol (18 and 9.6-μg) or budesonide-formoterol (320 and 9.6-μg) in patients with moderate-to-very-severe COPD with at least 1 exacerbation in the past year. Similar to previous trials, there was a significant reduction in the annual rate of moderate-to-severe exacerbations and improved patient-reported outcomes with triple therapy at both doses of budesonide in comparison to either dual therapy of LAMA-LABA or inhaled glucocorticoid-LABA, and lower all-cause mortality in the 320-μg budesonide triple-therapy group in comparison to the LAMA-LABA dual therapy group.
Source: Rabe KF, Martinez FJ, Ferguson GT, et al. Triple inhaled therapy at two glucocorticoid doses in moderate-to-very-severe COPD. N Engl J Med. 2020;383:35–48.