RESULTS: A total of 3362 patients were randomized in the FLAME study, and 744 patients were randomized in the LANTERN study. IND/GLY significantly reduced the annualized rate of moderate or severe COPD exacerbations in patients with ≥1 exacerbation in previous year from the FLAME study (rate ratio [RR], 0.83; 95% CI, 0.75 to 0.91; P < 0.001), demonstrating a clinically meaningful 17% reduction versus SFC. The rate reduction was also significant with IND/GLY versus SFC in patients with a history of 0-1 exacerbation in the LANTERN study (RR, 0.69; 95% CI, 0.48 to 1.00; P = 0.048). In patients with ≥1 exacerbation in previous year, IND/GLY delayed the time to first moderate or severe exacerbation, with a clinically meaningful 22% risk reduction compared with SFC (HR, 0.78; 95% CI, 0.70 to 0.86; P < 0.001). The time to first moderate or severe exacerbation was also significantly prolonged with IND/GLY in patients with ≤1 exacerbation in the previous year, with a risk reduction of 35% versus SFC (HR, 0.65; 95% CI, 0.44 to 0.95; P = 0.028).