| 1 Trough FEV1 (by dose) |
10 |
5001 |
Mean Difference (Fixed, 95% CI) |
149.11 [137.09, 161.12] |
| 1.1 Indacaterol 75 mcg |
2 |
594 |
Mean Difference (Fixed, 95% CI) |
130.0 [101.72, 158.28] |
| 1.2 Indacaterol 150 mcg |
6 |
2521 |
Mean Difference (Fixed, 95% CI) |
146.52 [129.94, 163.11] |
| 1.3 Indacaterol 300 mcg |
5 |
1438 |
Mean Difference (Fixed, 95% CI) |
169.27 [144.52, 194.02] |
| 1.4 Indacaterol 600 mcg |
1 |
448 |
Mean Difference (Fixed, 95% CI) |
150.0 [100.62, 199.38] |
| 2 Trough FEV1 (by trial duration) |
10 |
4993 |
Mean Difference (Fixed, 95% CI) |
149.16 [137.06, 161.26] |
| 2.1 Trials < 24 weeks |
5 |
1340 |
Mean Difference (Fixed, 95% CI) |
148.99 [129.11, 168.86] |
| 2.2 Trials ≥ 24 weeks |
5 |
3653 |
Mean Difference (Fixed, 95% CI) |
149.26 [134.01, 164.51] |
| 3 Quality of life (by dose) |
10 |
4938 |
Mean Difference (Fixed, 95% CI) |
‐3.60 [‐4.36, ‐2.83] |
| 3.1 Indacaterol 75 mcg |
2 |
583 |
Mean Difference (Fixed, 95% CI) |
‐3.70 [‐5.66, ‐1.74] |
| 3.2 Indacaterol 150 mcg |
6 |
2502 |
Mean Difference (Fixed, 95% CI) |
‐3.43 [‐4.53, ‐2.32] |
| 3.3 Indacaterol 300 mcg |
5 |
1408 |
Mean Difference (Fixed, 95% CI) |
‐3.49 [‐4.94, ‐2.03] |
| 3.4 Indacaterol 600 mcg |
1 |
445 |
Mean Difference (Fixed, 95% CI) |
‐4.6 [‐7.07, ‐2.13] |
| 4 Quality of lIfe (by trial duration) |
10 |
4975 |
Mean Difference (Fixed, 95% CI) |
‐3.44 [‐4.25, ‐2.63] |
| 4.1 Trials < 24 weeks |
5 |
1329 |
Mean Difference (Fixed, 95% CI) |
‐4.11 [‐5.60, ‐2.62] |
| 4.2 Trials ≥ 24 weeks |
5 |
3646 |
Mean Difference (Fixed, 95% CI) |
‐3.15 [‐4.12, ‐2.19] |
| 5 Number of participants with a clinically significant improvement in quality of life (by dose) |
9 |
4906 |
Odds Ratio (Fixed, 95% CI) |
1.64 [1.46, 1.85] |
| 5.1 Indacaterol 75 mcg |
2 |
583 |
Odds Ratio (Fixed, 95% CI) |
1.73 [1.24, 2.41] |
| 5.2 Indacaterol 150 mcg |
6 |
2502 |
Odds Ratio (Fixed, 95% CI) |
1.67 [1.41, 1.98] |
| 5.3 Indcaterol 300 mcg |
4 |
1376 |
Odds Ratio (Fixed, 95% CI) |
1.46 [1.15, 1.85] |
| 5.4 Indacaterol 600 mcg |
1 |
445 |
Odds Ratio (Fixed, 95% CI) |
1.95 [1.30, 2.94] |
| 6 Number of participants with a clinically significant improvement in quality of life (by trial duration) |
9 |
4972 |
Odds Ratio (Fixed, 95% CI) |
1.56 [1.38, 1.76] |
| 6.1 Trials < 24 weeks' duration |
4 |
1284 |
Odds Ratio (Fixed, 95% CI) |
1.90 [1.51, 2.38] |
| 6.2 Trials ≥ 24 weeks' duration |
5 |
3688 |
Odds Ratio (Fixed, 95% CI) |
1.45 [1.26, 1.67] |
| 7 End‐of‐study dyspnoea (by dose) |
8 |
4577 |
Mean Difference (Fixed, 95% CI) |
1.00 [0.82, 1.17] |
| 7.1 Indacaterol 300 mcg |
4 |
1403 |
Mean Difference (Fixed, 95% CI) |
1.13 [0.83, 1.43] |
| 7.2 Indacaterol 75 mcg |
2 |
597 |
Mean Difference (Fixed, 95% CI) |
0.77 [0.27, 1.27] |
| 7.3 Indacaterol 150 mcg |
5 |
2138 |
Mean Difference (Fixed, 95% CI) |
0.96 [0.70, 1.22] |
| 7.4 Indacaterol 600 mcg |
1 |
439 |
Mean Difference (Fixed, 95% CI) |
0.98 [0.51, 1.45] |
| 8 Number of participants experiencing a clinically significant improvement in dyspnoea |
8 |
4577 |
Odds Ratio (Fixed, 95% CI) |
1.96 [1.73, 2.22] |
| 8.1 Indacaterol 75 mcg |
2 |
597 |
Odds Ratio (Fixed, 95% CI) |
1.76 [1.26, 2.45] |
| 8.2 Indacaterol 150 mcg |
5 |
2138 |
Odds Ratio (Fixed, 95% CI) |
1.87 [1.56, 2.24] |
| 8.3 Indacaterol 300 mcg |
4 |
1403 |
Odds Ratio (Fixed, 95% CI) |
2.25 [1.81, 2.81] |
| 8.4 Indacaterol 600 mcg |
1 |
439 |
Odds Ratio (Fixed, 95% CI) |
1.80 [1.20, 2.70] |
| 9 Peak FEV1 |
6 |
1657 |
Mean Difference (IV, Fixed, 95% CI) |
181.21 [129.10, 233.32] |
| 9.1 Indacaterol 75 mcg |
2 |
545 |
Mean Difference (IV, Fixed, 95% CI) |
196.56 [107.15, 285.98] |
| 9.2 Indacaterol 150 mcg |
3 |
601 |
Mean Difference (IV, Fixed, 95% CI) |
200.91 [111.71, 290.12] |
| 9.3 Indacaterol 300 mcg |
3 |
383 |
Mean Difference (IV, Fixed, 95% CI) |
173.50 [69.92, 277.09] |
| 9.4 Indacterol 600 mcg |
1 |
128 |
Mean Difference (IV, Fixed, 95% CI) |
30.0 [‐172.77, 232.77] |
| 10 Serious adverse events |
9 |
6065 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.00 [0.82, 1.23] |
| 10.1 Indacaterol 75 mcg |
2 |
641 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.60 [0.24, 1.46] |
| 10.2 Indacaterol 150 mcg |
6 |
2958 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.01 [0.75, 1.37] |
| 10.3 Indacaterol 300 mcg |
4 |
1825 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.74, 1.45] |
| 10.4 Indacaterol 600 mcg |
1 |
641 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.09 [0.65, 1.83] |
| 11 Mortality |
9 |
5694 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.42 [0.16, 1.08] |
| 11.1 Indacaterol 75 mcg |
2 |
641 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.19 [0.01, 4.07] |
| 11.2 Indacaterol 150 mcg |
5 |
2586 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.86 [0.23, 3.16] |
| 11.3 Indacaterol 300 mcg |
4 |
1826 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.25 [0.02, 2.72] |
| 11.4 Indacaterol 600 mcg |
1 |
641 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.10 [0.00, 2.11] |
| 12 Number of participants experiencing at least 1 protocol‐defined exacerbation |
7 |
4807 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.70, 0.94] |
| 12.1 75 mcg |
2 |
638 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.49, 1.45] |
| 12.2 150 mcg |
4 |
2170 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.66, 1.02] |
| 12.3 300 mcg |
3 |
1403 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.84 [0.65, 1.09] |
| 12.4 600 mcg |
1 |
596 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.74 [0.51, 1.06] |
