Main outcomes of the IMPACT and ETHOS trials
| Study | Primary outcome: rate of moderate/severe exacerbations per year | Secondary/exploratory outcomes | ||
| Mean SGRQ | Lung function | Mortality | ||
| IMPACT | • 0.91 with triple therapy | Mean change from baseline in SGRQ: | Mean change from baseline in FEV1: | • 50 (1.2%) deaths in the FF/UMEC/VI arm |
| • 1.07 with FF/VI (RR with triple therapy of 0.85 (95% CI 0.80–0.90); p<0.001) | • −1.8 (−2.4 to −1.1; p <0.001) with triple therapy compared with FF/VI | • +97 mL (85–109); p<0.001 with triple therapy compared with FF/VI | • 49 (1.2%) in the FF/VI arm (no difference with FF/UMEC/VI) | |
| • 1.21 with UMEC/VI (RR with triple therapy of 0.75 (95% CI 0.70–0.81); p<0.001) | • −1.8 (−2.6 to −1.0; p <0.001) with triple therapy compared with UMEC/VI | • +54 mL (39–69); p<0.001 with triple therapy compared with UMEC/VI | • 39 (1.9%) in the UMEC/VI arm (HR of 0.58 (95% CI 0.38–0.88), p=0.011, between FF/UMEC/VI and UMEC/VI) | |
| ETHOS | • 1.08 with high-dose triple-therapy | Mean change from baseline in SGRQ: | Least square means change from baseline in FEV1: | • 28 (1.3%) deaths in the high-dose triple therapy arm |
| • 1.07 with low-dose triple-therapy | • −1.88 (−2.84 to −0.91) with high-dose triple therapy compared with GLY/FOR | • +35 mL (12–57); p=0.003 with triple therapy compared with GLY/FOR | • 39 (1.8%) in the low-dose triple therapy arm (no difference with high-dose triple therapy arm) | |
| • 1.42 with GLY/FOR (RR with high-dose triple therapy of 0.76 (95% CI 0.69–0.83); p<0.001) | • −1.47 (−2.43 to −0.51) with high-dose triple therapy compared with BUD/FOR | • +76 mL (54–99); p<0.0001 with triple therapy compared with GLY/FOR | • 49 (2.3%) in the GLY/FOR arm (HR of 0.51 (95% CI 0.33–0.80), p=0.004, between triple therapy and GLY/FOR) | |
| • 1.24 with BUD/FOR (RR with high-dose triple therapy of 0.87 (95% CI 0.79–0.95); p=0.003) | • 34 (1.6%) in the BUD/FOR arm (HR of 0.72 (95% CI 0.44–1.16), p=0.17, between triple therapy and BUD/FOR) | |||
SGRQ: St George's Respiratory Questionnaire; FEV1: forced expiratory volume in 1 s; FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol; RR: rate ratio; HR: hazard ratio; BUD: budesonide; GLY: glycopyrrolate; FOR: formoterol.