Table 2.

Change from baseline in trough FEV₁ at week 8 (A) and analysis of change from baseline in FEV₁ at week 8 by smoking status and previous use of fixed-dose combination of inhaled β₂-agonist and ICS (B)

	Indacaterol, LS, mean ± SE	Placebo, LS, mean ± SE	Treatment difference, LS, mean (95% CI)	P-value
A
ITT	0.08±0.02	−0.06±0.02	0.14 (0.09, 0.18)	<0.001
PP	0.10±0.02	−0.04±0.02	0.14 (0.09, 0.19)	<0.001
B
Smoking status
ITT
Yes	0.07±0.03	−0.07±0.02	0.14 (0.07, 0.21)	<0.001
No	0.09±0.02	−0.05±0.02	0.14 (0.08, 0.19)	<0.001
PP
Yes	0.11±0.02	−0.05±0.02	0.16 (0.09, 0.23)	<0.001
No	0.10±0.02	−0.03±0.03	0.13 (0.05, 0.20)	0.001
ICS/LABA use
ITT
Yes	0.05±0.03	−0.07±0.03	0.12 (0.03, 0.20)	0.01
No	0.10±0.02	−0.05±0.02	0.15 (0.10, 0.21)	<0.001
PP
Yes	0.08±0.03	−0.04±0.03	0.12 (0.03, 0.20)	0.007
No	0.11±0.02	−0.04±0.02	0.15 (0.09, 0.21)	<0.001

Abbreviations: CI, confidence interval; FEV₁, forced expiratory volume in 1 s; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting β₂-agonist; LS, least squares; PP, per protocol; SE, standard error.