Primary and additional efficacy outcomes
| Placebo (least squares mean, SE) | Difference vs placebo (least squares mean, 95% CI) | |||
| Indacaterol 300 μg | Indacaterol 600 μg | Formoterol | ||
| Trough FEV1, l§ | ||||
| After 1 day | 1.31 (0.009) | +0.14 (0.11 to 0.16)***† | +0.17 (0.15 to 0.20)***††† | +0.11 (0.09 to 0.13)*** |
| At week 12 | 1.31 (0.013) | +0.17 (0.13 to 0.20)***††† | +0.17 (0.13 to 0.20)***††† | +0.07 (0.04 to 0.10)*** |
| At week 52 | 1.28 (0.017) | +0.16 (0.12 to 0.20)***††† | +0.15 (0.11 to 0.19)***††† | +0.05 (0.01 to 0.09)* |
| TDI score§ | ||||
| At week 12 | 1.22 (0.185) | +1.17 (0.76 to 1.58)***† | +1.13 (0.71 to 1.54)***† | +0.72 (0.30 to 1.13)*** |
| At week 52 | 1.57 (0.230) | +1.00 (0.53 to 1.47)*** | +0.98 (0.51 to 1.46)*** | +0.71 (0.24 to 1.19)** |
| Diary card data (over 52 weeks) | ||||
| Days of poor COPD control, % | 38.3 (1.47) | −4.7 (−8.4 to −1.0)* | −8.3 (−12.0 to −4.6)*** | −4.8 (−8.5 to −1.1)* |
| Change from baseline in mean daily inhalations of salbutamol as-needed | −0.02 (0.127) | −1.67 (−1.97 to 1.37)***† | −1.66 (−1.96 to −1.36)***† | −1.33 (−1.63 to 1.03)*** |
| Days with no use of as-needed salbutamol, % | 34.8 (1.88) | +23.6 (19.0 to 28.1)***†† | +26.6 (22.0 to 31.2)***††† | +17.3 (12.2 to 21.9)*** |
| Days with no daytime symptoms, % | 6.2 (0.93) | +2.7 (0.3 to 5.1)* | +2.4 (0.0 to 4.8) | +2.9 (0.5 to 5.3)* |
| Days able to perform usual daily activities, % | 34.1 (1.53) | +8.5 (4.6 to 12.5)*** | +9.0 (5.0 to 13.0)*** | +6.2 (2.3 to 10.2)** |
| Nights with no awakenings, % | 67.5 (1.40) | +6.6 (3.1 to 10.1)*** | +9.0 (5.5 to 12.4)***†† | +4.2 (0.8 to 7.7)* |
| Change from baseline in morning (predose) PEF, l/min | 1.7 (2.18) | +28.3 (22.8 to 33.8)***††† | +31.1 (25.6 to 36.7)***††† | +17.0 (11.5 to 22.6)*** |
| Change from baseline in evening PEF, l/min | 2.9 (2.20) | +24.6 (19.2 to 30.1)***††† | +28.3 (22.8 to 33.8)***††† | +15.7 (10.2 to 21.1)*** |
| SGRQ total score§ | ||||
| At week 12 | 41.3 (0.72) | −3.8 (−5.6 to −2.1)*** | −4.1 (−5.9 to −2.3)*** | −3.2 (−5.0 to −1.5)*** |
| At week 52 | 41.3 (0.87) | −4.7 (−6.7 to −2.7)*** | −4.6 (−6.6 to −2.6)*** | −4.0 (−6.0 to −2.0)*** |
| BODE index‡ | ||||
| At week 12 | 2.67 (0.064) | −0.40 (−0.56 to −0.25)*** | −0.24 (−0.40 to −0.08)** | −0.28 (−0.43 to −0.12)*** |
| At week 52 | 2.90 (0.076) | −0.55 (−0.73 to 0.37)*** | −0.49 (−0.68 to −0.31)*** | −0.53 (−0.72 to −0.35)*** |
Data are least squares means.
*p<0.05, **p<0.01, ***p<0.001. Dagger symbols denote where significant treatment differences (not shown) occur vs formoterol (†p<0.05, ††p<0.01, †††p≤0.001).
↵‡ Negative changes represent an improvement in the BODE index.
↵§ Minimum clinically important differences are 120 ml (trough FEV1), 1 point (TDI total score14 15) and 4 points (SGRQ total score16).
BODE index, body mass index, obstruction, dyspnoea, exercise; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; PEF, peak expiratory flow; SGRQ, St George's Respiratory Questionnaire; TDI, transition dyspnoea index.