. 2016 Jul 20;16:102. doi: 10.1186/s12890-016-0266-5

Table 3.

Peak FVC and FVC AUC outcomes (safety population)

FVC variable (L)	Comparison	LS mean differences in changes from baseline
		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 AUC_0-12 at Day 1	vs placebo	0.227	0.169, 0.284	<0.0001	0.280	0.222, 0.337	<0.0001	0.301	0.243, 0.358	<0.0001	0.347	0.289, 0.405	<0.0001
Normalised AUC_0-12 at Day 1	vs indacaterol	0.010	−0.047, 0.068	0.7258	0.063	0.05, 0.121	0.0323	0.084	0.027, 0.142	0.0044	0.130	0.072, 0.188	<0.0001
Normalised AUC_12-24 at Day 1	vs placebo	0.182	0.114, 0.249	<0.0001	0.308	0.201, 0.376	<0.0001	0.352	0.285, 0.420	<0.0001	0.386	0.319, 0.454	<0.0001
Normalised AUC_12-24 at Day 1	vs indacaterol	−0.026	−0.094, 0.042	0.4471	0.100	0.031, 0.166	0.0045	0.144	0.076, 0.212	<0.0001	0.178	0.110, 0.247	<0.0001
Normalised AUC_0-24 at Day 1	vs placebo	0.208	0.153, 0.263	<0.0001	0.294	0.239, 0.349	<0.0001	0.332	0.276, 0.387	<0.0001	0.369	0.313, 0.424	<0.0001
Normalised AUC_0-24 at Day 1	vs indacaterol	−0.007	−0.063, 0.048	0.7996	0.079	0.023, 0.135	0.0058	0.117	0.061, 0.172	<0.0001	0.154	0.098, 0.209	<0.0001
Peak FVC at Day 1	vs placebo	0.152	0.035, 0.270	0.0110	0.191	0.074, 0.309	0.0015	0.201	0.083, 0.318	0.0009	0.244	0.127, 0.361	<0.0001
Peak FVC at Day 1	vs indacaterol	0.013	−0.104, 0.131	0.8219	0.052	−0.065, 0.170	0.3829	0.062	−0.056, 0.179	0.3024	0.105	−0.012, 0.222	0.0795

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 FVC 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 immediately after morning IMP administration, AUC _0-24 area under the curve over the 24 h period immediately after morning IMP administration, CI confidence interval, FVC forced vital capacity, IMP investigational medicinal product, ITT intent-to-treat, LS least squares, N ITT population size of treatment group