TABLE 2

Mean annual moderate/severe exacerbation rates by subgroup (intent-to-treat (ITT) population; up to week 24)

Subgroup	FF/UMEC/VI		BUD/FOR		Rate reduction % (95% CI)
Subgroup	n	Rate	n	Rate	Rate reduction % (95% CI)
Patients	911		899
Prior medication
ICS+LABA	266	0.10	258	0.27	63 (29–80)***
BUD+FOR	87	0.05	83	0.10	54 (−74–88)
ICS+LABA+LAMA	256	0.28	254	0.53	47 (13–67)*
LAMA alone	79	0.12	79	0.23	49 (−42–81)
TIO alone	65	0.15	67	0.20	24 (−125–74)
LAMA+LABA	100	0.38	83	0.26	−44 (−194–29)
Disease severity
FEV₁ % pred <50%, no moderate/severe exacerbations	311	0.22	315	0.33	33 (−4–57)
FEV₁ % pred <50%, ≥1 moderate/severe exacerbation	299	0.22	290	0.41	45 (11–66)*
FEV₁ % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations	296	0.22	289	0.30	27 (−21–56)
Exacerbation history
0/1 moderate exacerbations	599	0.25	609	0.40	36 (11–54)**
≥2 moderate exacerbations	308	0.24	283	0.32	25 (−23–55)
≥1 severe exacerbations	185	0.13	198	0.32	59 (17–80)*

FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg); ICS: inhaled corticosteroid; LABA: long-acting β₂-agonist; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FEV₁: forced expiratory volume in 1 s. *: p<0.05; **: p<0.01; ***: p<0.005, statistically significant difference for FF/UMEC/VI:BUD/FOR ratio.