1 Change from baseline in FEV1 |
5 |
1633 |
L (Fixed, 95% CI) |
‐0.02 [‐0.05, 0.00] |
1.1 Children |
1 |
621 |
L (Fixed, 95% CI) |
‐0.02 [‐0.06, 0.02] |
1.2 Adults |
4 |
1012 |
L (Fixed, 95% CI) |
‐0.03 [‐0.06, 0.01] |
2 Change from baseline in FVC |
5 |
1637 |
L (Fixed, 95% CI) |
‐0.01 [‐0.04, 0.03] |
2.1 Children |
1 |
621 |
L (Fixed, 95% CI) |
‐0.02 [‐0.07, 0.02] |
2.2 Adults |
4 |
1016 |
L (Fixed, 95% CI) |
0.02 [‐0.03, 0.07] |
3 Change in clinic PEF |
1 |
|
L/min (Fixed, 95% CI) |
Totals not selected |
3.1 Children |
0 |
|
L/min (Fixed, 95% CI) |
0.0 [0.0, 0.0] |
3.2 Adults |
1 |
|
L/min (Fixed, 95% CI) |
0.0 [0.0, 0.0] |
4 Change in am PEF |
4 |
1423 |
L/min (Fixed, 95% CI) |
0.07 [‐5.05, 5.19] |
4.1 Children |
1 |
621 |
L/min (Fixed, 95% CI) |
‐2.3 [‐8.90, 4.30] |
4.2 Adults |
3 |
802 |
L/min (Fixed, 95% CI) |
3.64 [‐4.47, 11.74] |
5 Change in pm PEF |
4 |
1423 |
L/min (Fixed, 95% CI) |
3.29 [‐1.62, 8.19] |
5.1 Children |
1 |
621 |
L/min (Fixed, 95% CI) |
3.3 [‐1.00, 9.60] |
5.2 Adults |
3 |
802 |
L/min (Fixed, 95% CI) |
3.27 [‐4.54, 11.09] |
6 Change in quality of life (Paediatric AQLQ) |
2 |
1010 |
AQLQ (Fixed, 95% CI) |
‐0.00 [‐0.09, 0.09] |
7 Adverse events |
6 |
1912 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.92, 1.17] |
7.1 Children |
1 |
621 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.00 [0.81, 1.24] |
7.2 Adults |
5 |
1291 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.91, 1.23] |
8 Worsening asthma |
2 |
404 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.91 [0.49, 1.69] |
8.1 Children |
0 |
0 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
8.2 Adults |
2 |
404 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.91 [0.49, 1.69] |
9 Upper respiratory tract infection |
6 |
1802 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.05 [0.75, 1.47] |
9.1 Children |
1 |
621 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.57 [0.28, 1.17] |
9.2 Adults |
5 |
1181 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.27 [0.86, 1.88] |
10 Pharyngitis |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
10.1 Children |
0 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
10.2 Adults |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
11 Rhinitis |
2 |
404 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.37 [0.08, 1.62] |
11.1 Children |
0 |
0 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
11.2 Adults |
2 |
404 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.37 [0.08, 1.62] |
12 Oral candidiasis |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
12.1 Children |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
12.2 Adults |
0 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
13 Withdrawals |
4 |
1427 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.31 [0.82, 2.11] |
13.1 Children |
1 |
621 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.17 [0.83, 5.64] |
13.2 Adults |
3 |
806 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.61, 1.84] |
14 Withdrawals (lack of efficacy) |
3 |
1024 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.45 [0.84, 7.13] |
14.1 Children |
1 |
621 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.96 [0.67, 13.09] |
14.2 Adults |
2 |
403 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.95 [0.42, 9.10] |
15 Withdrawals (adverse events) |
4 |
777 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.61 [0.96, 7.07] |
15.1 Children |
0 |
0 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
15.2 Adults |
4 |
777 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.61 [0.96, 7.07] |