| 1 FEV1 at endpoint |
1 |
|
L (Fixed, 95% CI) |
Totals not selected |
| 1.1 Children |
0 |
|
L (Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 1.2 Adults |
1 |
|
L (Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 2 Change in FEV1 |
4 |
1543 |
L (Fixed, 95% CI) |
0.12 [0.08, 0.15] |
| 2.1 Children |
1 |
507 |
L (Fixed, 95% CI) |
0.07 [0.02, 0.12] |
| 2.2 Adults |
3 |
1036 |
L (Fixed, 95% CI) |
0.17 [0.12, 0.22] |
| 3 Change in FEV1 predicted |
3 |
1171 |
Mean Difference (IV, Fixed, 95% CI) |
3.06 [1.85, 4.26] |
| 3.1 Children |
1 |
507 |
Mean Difference (IV, Fixed, 95% CI) |
3.48 [0.86, 6.10] |
| 3.2 Adults |
2 |
664 |
Mean Difference (IV, Fixed, 95% CI) |
2.94 [1.58, 4.30] |
| 4 Change in FVC |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 4.1 Children |
0 |
|
Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 4.2 Adults |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 5 Change in clinic PEF (L/min) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 5.1 Children |
0 |
|
Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 5.2 Adults |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 6 Change in am PEF |
5 |
1768 |
L/min (Fixed, 95% CI) |
18.66 [14.74, 22.57] |
| 6.1 Children |
1 |
507 |
L/min (Fixed, 95% CI) |
7.53 [0.49, 14.57] |
| 6.2 Adults |
4 |
1261 |
L/min (Fixed, 95% CI) |
23.64 [18.93, 28.35] |
| 7 Change in pm PEF (L/min) |
4 |
1383 |
Mean Difference (IV, Fixed, 95% CI) |
13.93 [9.52, 18.35] |
| 7.1 Children |
1 |
507 |
Mean Difference (IV, Fixed, 95% CI) |
8.7 [2.40, 15.00] |
| 7.2 Adults |
3 |
876 |
Mean Difference (IV, Fixed, 95% CI) |
18.97 [12.78, 25.15] |
| 8 Change in rescue 2‐agonists use |
3 |
1034 |
Puffs/d (Fixed, 95% CI) |
‐1.11 [‐1.32, ‐0.89] |
| 8.1 Children |
0 |
0 |
Puffs/d (Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 8.2 Adults |
3 |
1034 |
Puffs/d (Fixed, 95% CI) |
‐1.11 [‐1.32, ‐0.89] |
| 9 Change in asthma symptom scores |
3 |
1091 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.51 [‐0.65, ‐0.38] |
| 9.1 Children |
0 |
0 |
Std. Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 9.2 Adults |
3 |
1091 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.51 [‐0.65, ‐0.38] |
| 10 Change in nighttime awakenings (SMD) |
2 |
874 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.34 [‐0.47, ‐0.20] |
| 10.1 Children |
0 |
0 |
Std. Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 10.2 Adults |
2 |
874 |
Std. Mean Difference (IV, Fixed, 95% CI) |
‐0.34 [‐0.47, ‐0.20] |
| 11 Change in quality of life score (paediatric AQLQ) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 12 Change from baseline in quality of life score (AQLQ) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 12.1 Children |
0 |
|
Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 12.2 Adults |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 13 Loss of efficacy |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 14 Withdrawals |
3 |
877 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.55 [0.43, 0.70] |
| 14.1 Children |
1 |
510 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.62 [0.41, 0.93] |
| 14.2 Adults |
2 |
367 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.51 [0.38, 0.69] |
| 15 Withdrawals (lack of efficacy) |
3 |
1159 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.31 [0.22, 0.45] |
| 15.1 Children |
1 |
510 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.44 [0.24, 0.81] |
| 15.2 Adults |
2 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.26 [0.16, 0.41] |
| 16 Withdrawals (adverse events) |
3 |
1159 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.39 [0.27, 0.56] |
| 16.1 Children |
1 |
510 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.48 [0.27, 0.84] |
| 16.2 Adults |
2 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.34 [0.22, 0.55] |
| 17 Changes in cortisol levels (serum) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 18 Changes in cortisol levels (urinary) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
| 19 Asthma (not otherwise specified) |
2 |
724 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.59 [0.43, 0.83] |
| 19.1 Children |
1 |
507 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.67 [0.44, 1.01] |
| 19.2 Adults |
1 |
217 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.48 [0.28, 0.84] |
| 20 Candidiasis |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 20.1 Children |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 20.2 Adults |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 21 Sore throat |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 22 Voice alteration |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 23 Headache |
3 |
877 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.96 [0.66, 1.41] |
| 23.1 Children |
1 |
510 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.13 [0.69, 1.87] |
| 23.2 Adults |
2 |
367 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.76 [0.41, 1.38] |
| 24 Upper respiratory tract infection |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 24.2 Adults |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 25 Symptoms of asthma (wheeze, dsypnea or cough) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 26 Rhinitis |
2 |
727 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.58 [0.33, 1.00] |
| 26.1 Children |
1 |
510 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.54 [0.23, 1.26] |
| 26.2 Adults |
1 |
217 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.60 [0.29, 1.26] |
| 27 Adverse event |
2 |
670 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.84, 1.05] |
| 27.1 Children |
1 |
510 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.99 [0.89, 1.11] |
| 27.2 Adults |
1 |
160 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.74 [0.54, 1.01] |
| 28 Pharyngitis |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 28.1 Children |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 28.2 Adults |
0 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 29 Nasopharyngitis |
2 |
660 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.14 [0.81, 1.61] |
| 29.1 Children |
1 |
510 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.29 [0.79, 2.09] |
| 29.2 Adults |
1 |
150 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.60, 1.59] |