Table 2.

Effect of 52 weeks’ treatment on pre-bronchodilator FEV₁ according to baseline severity and therapy group

Analysis	Population (n)	Placebo (353)	Sal/FP (345)	Sal (361)	FP (371)
Categorical	FEV1<50% predicted
	Patients (n)	234	226	238	233
	Mean baseline FEV1(L)	1.02	1.03	1.03	1.03
	Treatment differencea vs placebo (95% CI)	-	110 (75, 145)	42 (7, 76)	18 (−16, 53)
	Treatment difference vs Sal/FP (95% CI)	-	-	69 (34, 103)	92 (57, 126)
	p-value vs placebo	-	<0.001	0.017	0.296
	p-value vs Sal/FP	-	-	<0.001	<0.001
	FEV1≥50% predicted
	Patients (n)	119	119	123	138
	Mean baseline FEV1(L)	1.73	1.84	1.65	1.65
	Treatment difference vs placebo (95% CI)	-	176 (128, 225)	96 (48, 143)	79 (33, 126)
	Treatment difference vs Sal/FP (95% CI)	-	-	81 (33, 129)	97 (51, 144)
	p-value vs placebo	-	<0.001	<0.001	<0.001
	p-value vs Sal/FP	-	-	<0.001	<0.001
	At 25th percentile (33% predicted)
Continuous	Treatment difference vs placebo (95% CI)	-	113 (77, 149)	38 (2, 74)	18 (−18, 54)
	Treatment difference vs Sal/FP (95% CI)	-	-	75 (39, 110)	94 (58, 130)
	p-value vs placebo	-	<0.001	0.037	0.316
	p-value vs Sal/FP	-	-	<0.001	<0.001
	At median (44% predicted)
	Treatment difference vs placebo (95% CI)	-	132 (104, 160)	61 (33, 89)	40 (13, 67)
	Treatment difference vs Sal/FP (95% CI)	-	-	71 (43, 99)	92 (64, 119)
	p-value vs placebo	-	<0.001	<0.001	0.004
	p-value vs Sal/FP	-	-	<0.001	<0.001
	At 75th percentile (55% predicted)
	Treatment difference vs placebo (95% CI)	-	151 (116, 186)	84 (49, 119)	62 (27, 96)
	Treatment difference vs Sal/FP (95% CI)	-	-	67 (32, 102)	89 (55, 124)
	p-value vs placebo	-	<0.001	<0.001	<0.001
	p-value vs Sal/FP	-	-	<0.001	<0.001

^aTreatment difference=mL.

Abbreviations: FP, fluticasone propionate; Sal, salmeterol; Sal/FP, salmeterol and fluticasone propionate combination.