Table 2.

LS mean differences in changes from baseline in peak FEV₁ and FEV₁ AUC outcomes (ITT population)

FEV1 variable (L)	Comparison	Abediterol 0.625 μg (N = 67)			Abediterol 2.5 μg (N = 66)			Abediterol 5 μg (N = 66)			Abediterol 10 μg (N = 67)
		LS mean	95 % CI	p-value	LS mean	95 % CI	p-value	LS mean	95 % CI	p-value	LS mean	95 % CI	p-value
Normalised AUC0-12 at Day 1	vs placebo	0.164	0.134, 0.195	<0.0001	0.246	0.216, 0.277	<0.0001	0.255	0.224, 0.285	<0.0001	0.283	0.252, 0.313	<0.0001
	vs indacaterol	0.027	−0.004, 0.057	0.0826	0.109	0.079, 0.139	<0.0001	0.117	0.087, 0.148	<0.0001	0.145	0.115, 0.176	<0.0001
Normalised AUC12-24 at Day 1	vs placebo	0.131	0.095, 0.167	<0.0001	0.227	0.192, 0.263	<0.0001	0.264	0.228, 0.299	<0.0001	0.290	0.254, 0.326	<0.0001
	vs indacaterol	−0.002	−0.038, 0.035	0.9296	0.095	0.058, 0.131	<0.0001	0.131	0.095, 0.167	<0.0001	0.157	0.121, 0.193	<0.0001
Normalised AUC0-24 at Day 1	vs placebo	0.148	0.118, 0.179	<0.0001	0.237	0.206, 0.268	<0.0001	0.260	0.229, 0.291	<0.0001	0.286	0.255, 0.317	<0.0001
	vs indacaterol	0.014	−0.017, 0.045	0.3799	0.102	0.071, 0.134	<0.0001	0.125	0.094, 0.157	<0.0001	0.152	0.120, 0.183	<0.0001
Peak FEV1 at Day 1	vs placebo	0.185	0.147, 0.223	<0.0001	0.255	0.217, 0.292	<0.0001	0.257	0.219, 0.295	<0.0001	0.285	0.247, 0.323	<0.0001
	vs indacaterol	0.019	−0.019, 0.057	0.3350	0.089	0.050, 0.127	<0.0001	0.091	0.053, 0.129	<0.0001	0.119	0.081, 0.157	<0.0001

Analyses were performed on the ITT population. For both placebo and indacaterol, N = 68

LS mean differences and p-values obtained from an ANCOVA model for crossover designs with change from baseline in FEV₁ variable as response, sequence, treatment group and period as fixed effect factors, patient within sequence as a random effect and the corresponding baseline value at each period as a covariate

ANCOVA, analysis of covariance; AUC _0-12 area under the curve over the 12 h period immediately after morning IMP administration, AUC _12-24 area under the curve over the 12 h nighttime period after morning IMP administration, AUC _0-24 area under the curve over the 24 h period immediately after morning IMP administration, FEV ₁ forced expiratory volume in 1 s, IMP investigational medicinal product, ITT intent-to-treat, LS least squares, N ITT population size of treatment group