Abstract P272 Table 1

Mean annual exacerbation rates by subgroup (ITT population; up to Week 24)

Subgroup	FF/UMEC/VI 100/62.5/25 µg (n=911)		BUD/FOR 400/12 µg (n=899)		Reduction in annual exacerbation rate
Subgroup
n	rate	n	rate	%	(95% CI)

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<50%, no moderate/severe exacerbations	311	0.22	315	0.33	33	(−4–57)
FEV₁<50%,≥1 moderate/severe exacerbation	299	0.22	290	0.41	45*	(11–66)
FEV₁≥50–≤80%,≥2 moderate/≥1 severe exacerbations	296	0.22	289	0.30	27	(−21–56)
Exacerbation history
0/1 moderate	599	0.23	609	0.37	38*	(13–56)
≥2 moderate	308	0.01	283	0.02	27	(−20–55)
≥1 severe	185	0.12	200	0.29	57*	(14–78)

*Statistically significant difference for FF/UMEC/VI:BUD/FOR ratio; CI, confidence interval; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting beta agonists; LAMA, long-acting muscarinic antagonists; TIO, tiotropium.