Online data repository

Contents

Figure S1 Study design schematic

Table S1 Trough FEV1 at Week 12 for the ITT population (including non-conforming patients excluded from the mITT population)

Table S2 Trough FEV1 at Week 12 expressed as changes from baseline

Figure S2 Serial measurements of FVC from −15 min to 24 h post-dose measured in sub-set of patients with 12-h serial spirometry measurements

Table S3 Patient numbers at each time point for the serial measurements of FEV1 and FVC shown in figs 3 and S2

Table S4 Peak FEV1 in the first 4 h following the morning dose, FEV1 AUC (5 min to 4 h) and FEV1 AUC (5 min to 11 h 45 min) measured at Week 12 in sub-set of patients with 12-h serial spirometry assessments

Table S5 Change from baseline in peak FEV1 in the first 4 h following the morning dose measured at Week 12 in sub-set of patients with 12-h serial spirometry assessments

Figure S1 Study design schematic

Table S1 Trough FEV1 at Week 12 for the ITT population (including patients from sites excluded from the mITT analysis owing to non-conformance with good clinical practice)

Placebo
(least squares mean, SE) / Difference vs placebo (least squares mean, 95% CI)
Indacaterol 300 μg / Indacaterol 600 μg / Formoterol
1.31 (0.013) / +0.16 (0.12, 0.19)***††† / +0.16 (0.13, 0.20)***††† / +0.07 (0.04, 0.10)***
n=414 (indacaterol 300 µg), n=396 (indacaterol 600 µg), n=408 (formoterol); n=395 (placebo). ***p<0.001. Dagger symbols denote significant treatment differences (not shown) versus formoterol (†††p≤0.001).

Table S2 Trough FEV1 at baseline and at Week 12, expressed as changes from baseline

Placebo / Formoterol / Indacaterol 300 μg / Indacaterol 600 μg
Baseline (L) / 1.33 (0.461) / 1.32 (0.428) / 1.28 (0.407) / 1.29 (0.446)
Change from baseline (mL) /
20 (219) /
80 (238) /
190 (254) /
180 (257)
Change from baseline (%) /
1.5 /
6.1 /
14.8 /
14.0
Data are unadjusted means (SD).

Figure S2 Serial measurements of FVC from −15 min to 24 h post-dose measured in sub-set of patients with serial spirometry measurements. Data are least squares means ± SE. Treatment differences: p<0.001 for indacaterol 600 μg vs placebo at each time point, and for indacaterol 300 μg vs placebo apart from at 8 h (p=0.004), 10 h (p=0.003) and 23 h 10 min (p=0.014); p<0.05 for formoterol vs placebo at time points from 5 min to 8 h and at 11 h 45 min post-dose. P<0.05 for indacaterol 300 μg vs formoterol at −15 min and 11 h 45 min, and for indacaterol 600 μg vs formoterol at all time points apart from 5 min and 1 h post-dose. Patient numbers at each time point are shown in supplementary table S3.

Table S3 Patient numbers at each time point (relative to morning dosing) for the serial measurements of FEV1 and FVC in the serial spirometry sub-set of patients at Week 12.

Time / Indacaterol
300 µg / Indacaterol
600 µg /
Formoterol /
Placebo
−15 min / 102 / 100 / 103 / 94
5 min / 102 / 100 / 103 / 93
30 min / 102 / 100 / 103 / 94
1 h / 102 / 100 / 101 / 93
2 h / 102 / 97 / 102 / 91
4 h / 102 / 97 / 102 / 90
6 h / 102 / 93 / 101 / 88
8 h / 103 / 94 / 100 / 84
10 h / 102 / 95 / 99 / 87
11h 45 min / 99 / 96 / 97 / 87
23 h 10 min / 101 / 98 / 104 / 95
23 h 45 min / 101 / 98 / 103 / 94

Table S4 Peak FEV1 in the first 4 h following the morning dose, FEV1 AUC (5 min to 4 h) and FEV1 AUC (5 min to 11 h 45 min) measured at Week 12 in sub-set of patients with 12-h spirometry assessments

Difference vs placebo (mean, 95% CI)
Placebo (mean, SE) /
Formoterol / Indacaterol
300 μg / Indacaterol
600 μg
Peak FEV1 (L) / 1.41
(0.027) / +0.16
(0.10, 0.23)*** / +0.21
(0.15, 0.28)*** / +0.25
(0.18, 0.31)***†
FEV1 AUC 5 min to 4 h (L) / 1.31
(0.025) / +0.18
(0.12, 0.25)*** / +0.24
(0.18, 0.30)*** / +0.27
(0.21, 0.33)***††
FEV1 AUC 5 min to
11 h 45 min (L) / 1.33
(0.027) / +0.13
(0.07, 0.20)*** / +0.21
(0.14, 0.27)***† / +0.22
(0.16, 0.29)***††
Data are least squares means. AUC = area under curve. ***p<0.001 vs placebo; †p<0.05, ††p<0.01 vs formoterol

Table S5 Change from baseline in peak FEV1 in the first 4 h following the morning dose measured at Week 12 in sub-set of patients with 12-h spirometry assessments

Placebo /
Formoterol / Indacaterol
300 μg / Indacaterol
600 μg
Change from baseline (L) /
+0.12 (0.245) /
+0.27 (0.237) /
+0.32 (0.251) /
+0.34 (0.283)
Change from baseline (%) /
+8.6 /
+20.6 /
+25.4 /
+27.4
Data are unadjusted means and SD.