1 # patients with exacerbations requiring oral steroids
|
25 |
9833 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.88 [0.78, 0.98] |
1.1 Baseline FEV1 >= 80 % predicted
|
11 |
4755 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.97 [0.83, 1.13] |
1.2 Baseline FEV1 61-79 % predicted
|
12 |
4106 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.81 [0.68, 0.95] |
1.3 Baseline FEV1 <60% predicted
|
1 |
489 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.62 [0.36, 1.05] |
1.4 Baseline FEV1 unclear
|
1 |
483 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.33 [0.30, 5.87] |
2 # patients with exacerbations requiring hospitalisation
|
33 |
12573 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.02 [0.67, 1.56] |
2.1 Baseline FEV1 >= 80 % predicted
|
8 |
2721 |
Risk Ratio (M-H, Fixed, 95% CI) |
3.04 [0.48, 19.15] |
2.2 Baseline FEV1 61-79 % predicted
|
20 |
8266 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.00 [0.63, 1.57] |
2.3 Baseline FEV1 <= 60 % predicted
|
1 |
488 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.98 [0.06, 15.64] |
2.4 Baseline FEV1 unclear
|
4 |
1098 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.33 [0.03, 3.18] |
3 # withdrawals due to poor asthma control or exacerbation
|
29 |
10923 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.71 [0.56, 0.91] |
3.1 Baseline FEV1 >= 80 % predicted
|
9 |
2443 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.65 [0.45, 0.93] |
3.2 Baseline FEV1 61-79 % predicted
|
17 |
7111 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.81 [0.58, 1.12] |
3.3 Baseline FEV1 <= 60 % predicted
|
1 |
488 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.14 [0.01, 2.71] |
3.4 Baseline FEV1 predicted not reported
|
2 |
881 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.33 [0.01, 8.11] |
4 Total # withdrawals
|
39 |
13654 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.92 [0.84, 1.00] |
4.1 Baseline FEV1 >= 80 % predicted
|
9 |
2799 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.76 [0.61, 0.95] |
4.2 Baseline FEV1 61-79 % predicted
|
23 |
8851 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.95 [0.86, 1.05] |
4.3 Baseline FEV1 <= 60 % predicted
|
1 |
488 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.87 [0.56, 1.37] |
4.4 Baseline FEV1 predicted not reported
|
6 |
1516 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.99 [0.73, 1.34] |
5 # withdrawals due to adverse events
|
30 |
10017 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.99 [0.78, 1.26] |
5.1 Baseline FEV1 >= 80 % predicted
|
9 |
2799 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.92 [0.48, 1.76] |
5.2 Baseline FEV1 61-79 % predicted
|
18 |
6095 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.95 [0.72, 1.25] |
5.3 Baseline FEV1 <= 60 % predicted
|
1 |
488 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.18 [0.37, 3.82] |
5.4 Baseline FEV1 predicted not reported
|
2 |
635 |
Risk Ratio (M-H, Fixed, 95% CI) |
2.35 [0.68, 8.08] |
6 FEV1 at endpoint
|
11 |
2841 |
L (Fixed, 95% CI) |
0.08 [0.03, 0.13] |
6.1 Baseline FEV1 >= 80 % predicted |
0 |
0 |
L (Fixed, 95% CI) |
Not estimable |
6.2 Baseline FEV1 61-79 % predicted
|
10 |
2841 |
L (Fixed, 95% CI) |
0.09 [0.03, 0.14] |
6.3 Baseline FEV1 <= 60 % predicted |
0 |
0 |
L (Fixed, 95% CI) |
Not estimable |
6.4 Baseline FEV1 not reported
|
1 |
0 |
L (Fixed, 95% CI) |
−0.14 [−0.50, 0.22] |
7 FEV1 (predicted) at endpoint
|
7 |
|
Mean Difference (Fixed, 95% CI) |
1.78 [0.39, 3.18] |
7.1 Baseline FEV1 >= 80 % predicted
|
2 |
|
Mean Difference (Fixed, 95% CI) |
4.46 [1.38, 7.53] |
7.2 Baseline FEV1 61-79 % predicted
|
5 |
|
Mean Difference (Fixed, 95% CI) |
1.10 [−0.46, 2.66] |
8 Change in FEV1 at endpoint
|
22 |
8888 |
L (Fixed, 95% CI) |
0.08 [0.06, 0.09] |
8.1 Baseline FEV1 >= 80 % predicted
|
4 |
1798 |
L (Fixed, 95% CI) |
0.07 [0.05, 0.10] |
8.2 Baseline FEV1 61-79 % predicted
|
14 |
5874 |
L (Fixed, 95% CI) |
0.09 [0.06, 0.11] |
8.3 Baseline FEV1 <= 60 % predicted
|
1 |
478 |
L (Fixed, 95% CI) |
0.01 [−0.07, 0.09] |
8.4 Baseline FEV1 not reported
|
3 |
738 |
L (Fixed, 95% CI) |
0.05 [−0.00, 0.11] |
9 Change in FEV1 stratifying on treatment period
|
19 |
|
L (Fixed, 95% CI) |
0.09 [0.08, 0.11] |
9.1 At 6 +/− 2 weeks
|
5 |
|
L (Fixed, 95% CI) |
0.09 [0.05, 0.13] |
9.2 At 12 +/− 4 weeks
|
10 |
|
L (Fixed, 95% CI) |
0.10 [0.08, 0.12] |
9.3 At 24 +/− 4 weeks
|
8 |
|
L (Fixed, 95% CI) |
0.09 [0.06, 0.12] |
9.4 At 52 +/− 4 weeks
|
2 |
|
L (Fixed, 95% CI) |
0.07 [0.03, 0.12] |
10 Change in FEV1 (predicted) at endpoint
|
2 |
|
% (Fixed, 95% CI) |
0.35 [−0.18, 0.87] |
10.1 Baseline FEV1 >= 80 % predicted
|
1 |
|
% (Fixed, 95% CI) |
0.28 [−0.25, 0.81] |
10.2 Baseline FEV1 61-79 % predicted
|
1 |
|
% (Fixed, 95% CI) |
3.9 [−0.01, 7.81] |
11 Morning PEF at endpoint
|
14 |
2938 |
L/min (Random, 95% CI) |
23.31 [18.09, 28.52] |
11.1 Baseline FEV1 >= 80 % predicted
|
2 |
77 |
L/min (Random, 95% CI) |
26.43 [−11.11, 63.97] |
11.2 Baseline FEV1 61-79 % predicted
|
12 |
2861 |
L/min (Random, 95% CI) |
23.86 [17.94, 29.77] |
11.3 Baseline FEV1 <=60% predicted |
0 |
0 |
L/min (Random, 95% CI) |
Not estimable |
12 Change in morning or clinic PEF at endpoint
|
30 |
11143 |
L/min (Random, 95% CI) |
16.30 [13.48, 19.11] |
12.1 Baseline FEV1 >= 80 % predicted
|
7 |
2314 |
L/min (Random, 95% CI) |
11.74 [8.47, 15.00] |
12.2 Baseline FEV1 61-79 % predicted
|
17 |
6788 |
L/min (Random, 95% CI) |
18.64 [13.93, 23.34] |
12.3 Baseline FEV1 <=60% pedicted
|
1 |
478 |
L/min (Random, 95% CI) |
13.70 [4.13, 23.27] |
12.4 Baseline FEV1 not reported
|
5 |
1563 |
L/min (Random, 95% CI) |
16.30 [9.03, 23.56] |
13 Morning PEF (% predicted) at endpoint
|
5 |
1646 |
Mean Difference (IV, Random, 95% CI) |
3.45 [1.28, 5.63] |
13.1 Baseline FEV1 >=80% predicted
|
4 |
1299 |
Mean Difference (IV, Random, 95% CI) |
3.86 [1.37, 6.35] |
13.2 Baseline FEV1 61-79% of predicted
|
1 |
347 |
Mean Difference (IV, Random, 95% CI) |
1.0 [−4.68, 6.68] |
14 Evening PEF at endpoint
|
4 |
|
L/min (Fixed, 95% CI) |
16.79 [10.72, 22.85] |
14.1 Baseline FEV1 >=80% predicted
|
1 |
|
L/min (Fixed, 95% CI) |
4.0 [−37.59, 45.59] |
14.2 Baseline FEV1 61-79% of predicted
|
3 |
|
L/min (Fixed, 95% CI) |
17.07 [10.93, 23.20] |
14.3 Baseline FEV1 <= 60 % predicted |
0 |
|
L/min (Fixed, 95% CI) |
Not estimable |
15 Change in morning PEF (predicted) |
0 |
|
% (Random, 95% CI) |
Not estimable |
15.1 Baseline FEV1 >= 80 % predicted |
0 |
|
% (Random, 95% CI) |
Not estimable |
15.2 Baseline FEV1 61-79 % predicted |
0 |
|
% (Random, 95% CI) |
Not estimable |
15.3 Baseline FEV1 <=60% predicted |
0 |
|
% (Random, 95% CI) |
Not estimable |
15.4 Baseline FEV1 not reported |
0 |
|
% (Random, 95% CI) |
Not estimable |
16 Change in evening PEF at endpoint
|
22 |
8544 |
L/min (Random, 95% CI) |
13.70 [10.28, 17.12] |
16.1 Baseline FEV1 >=80% predicted
|
6 |
2737 |
L/min (Random, 95% CI) |
12.01 [7.99, 16.02] |
16.2 Baseline FEV1 61-79% of predicted
|
11 |
4332 |
L/min (Random, 95% CI) |
15.05 [8.98, 21.12] |
16.3 Baseline FEV1 <=60% predicted
|
1 |
478 |
L/min (Random, 95% CI) |
14.5 [5.47, 23.53] |
16.4 Baseline FEV1 not reported
|
4 |
997 |
L/min (Random, 95% CI) |
11.31 [3.85, 18.78] |
17 Change in evening PEF predicted |
0 |
|
% (Random, 95% CI) |
Totals not selected |
17.1 Baseline FEV1 >=80% predicted |
0 |
|
% (Random, 95% CI) |
Not estimable |
17.2 Baseline FEV1 61-79% of predicted |
0 |
|
% (Random, 95% CI) |
Not estimable |
17.3 Baseline FEV1 not reported |
0 |
|
% (Random, 95% CI) |
Not estimable |
18 PEF variability at endpoint
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
18.1 Baseline FEV1 61-79 % predicted
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
19 Change in PEF variability at endpoint
|
7 |
2353 |
Mean Difference (IV, Fixed, 95% CI) |
−4.55 [−6.32, −2.78] |
19.1 Baseline FEV1 >= 80 % predicted
|
1 |
232 |
Mean Difference (IV, Fixed, 95% CI) |
−5.4 [−7.83, −2.97] |
19.2 Baseline FEV1 61-79 % predicted
|
4 |
1245 |
Mean Difference (IV, Fixed, 95% CI) |
−4.66 [−7.95, −1.36] |
19.3 Baseline FEV1 <= 60 % predicted
|
2 |
876 |
Mean Difference (IV, Fixed, 95% CI) |
−1.90 [−6.05, 2.26] |
20 Change in daytime symptom score at endpoint
|
5 |
1965 |
Std. Mean Difference (IV, Fixed, 95% CI) |
−0.26 [−0.35, −0.17] |
20.1 Baseline FEV1 >= 80 % predicted
|
1 |
225 |
Std. Mean Difference (IV, Fixed, 95% CI) |
−0.14 [−0.40, 0.13] |
20.2 Baseline FEV1 61-79 % predicted
|
4 |
1740 |
Std. Mean Difference (IV, Fixed, 95% CI) |
−0.27 [−0.37, −0.18] |
20.3 Baseline FEV1 <= 60 % predicted |
0 |
0 |
Std. Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
21 Change in overall (24 hrs) symptom score at endpoint
|
6 |
2279 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.23 [−0.37, −0.08] |
21.1 Baseline FEV1 >= 80 % predicted
|
1 |
558 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.12 [−0.29, 0.05] |
21.2 Baseline FEV1 61-79 % predicted
|
4 |
1243 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.27 [−0.52, −0.03] |
21.3 Baseline FEV1 % <= 60%
|
1 |
478 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.26 [−0.44, −0.08] |
22 Change in % symptom-free days at endpoint
|
12 |
6039 |
% (Random, 95% CI) |
9.18 [6.02, 12.33] |
22.1 Baseline FEV1 >=80% predicted
|
3 |
1646 |
% (Random, 95% CI) |
5.67 [2.87, 8.46] |
22.2 Baseline FEV1 61-79% of predicted
|
8 |
3925 |
% (Random, 95% CI) |
12.32 [8.44, 16.21] |
22.3 Baseline FEV1 <=60% predicted |
0 |
0 |
% (Random, 95% CI) |
Not estimable |
22.4 Baseline FEV1 % predicted not reported
|
1 |
468 |
% (Random, 95% CI) |
1.9 [−1.18, 4.98] |
23 % symptom-free days at endpoint
|
8 |
3901 |
Mean Difference (IV, Random, 95% CI) |
5.81 [−1.14, 12.76] |
23.1 Baseline FEV1 >= 80 % predicted
|
2 |
555 |
Mean Difference (IV, Random, 95% CI) |
−2.38 [−6.92, 2.17] |
23.2 Baseline FEV1 61-79 % predicted
|
5 |
2960 |
Mean Difference (IV, Random, 95% CI) |
6.58 [−1.73, 14.90] |
23.3 Baseline FEV1 % predicted not reported
|
1 |
386 |
Mean Difference (IV, Random, 95% CI) |
18.80 [9.64, 27.96] |
24 Daytime symptom score at endpoint
|
5 |
2465 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.28 [−0.67, 0.11] |
24.1 Baseline FEV1 >= 80 % predicted
|
1 |
48 |
Std. Mean Difference (IV, Random, 95% CI) |
0.12 [−0.45, 0.69] |
24.2 Baseline FEV1 61-79 % predicted
|
4 |
2417 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.38 [−0.84, 0.07] |
25 Nighttime symptom score at endpoint
|
3 |
2082 |
Std. Mean Difference (IV, Fixed, 95% CI) |
−0.24 [−0.49, 0.01] |
25.1 Baseline FEV1 >= 80% predicted
|
1 |
48 |
Std. Mean Difference (IV, Fixed, 95% CI) |
−0.16 [−0.73, 0.41] |
25.2 Baseline FEV1 61-79 % predicted
|
2 |
2034 |
Std. Mean Difference (IV, Fixed, 95% CI) |
−0.26 [−0.54, 0.02] |
26 Change in nighttime symptom score at endpoint
|
2 |
710 |
Mean Difference (IV, Fixed, 95% CI) |
−0.01 [−0.04, 0.01] |
26.1 Baseline FEV1 61-79 % predicted
|
1 |
484 |
Mean Difference (IV, Fixed, 95% CI) |
−0.01 [−0.04, 0.02] |
26.2 Baseline FEV1 >= 80 % predicted
|
1 |
226 |
Mean Difference (IV, Fixed, 95% CI) |
−0.08 [−0.19, 0.03] |
27 % symptom-free nights at endpoint
|
2 |
580 |
Mean Difference (IV, Fixed, 95% CI) |
−2.10 [−7.98, 3.79] |
27.1 Baseline FEV1 >= 80 % predicted
|
1 |
231 |
Mean Difference (IV, Fixed, 95% CI) |
1.60 [−8.49, 11.69] |
27.2 Baseline FEV1 61-79 % predicted
|
1 |
349 |
Mean Difference (IV, Fixed, 95% CI) |
−4.0 [−11.24, 3.24] |
28 Change in night time awakenings ( number of nights) at endpoint
|
7 |
3172 |
Std. Mean Difference (IV, Fixed, 95% CI) |
−0.03 [−0.10, 0.04] |
28.1 Baseline FEV1 >= 80 % predicted
|
1 |
558 |
Std. Mean Difference (IV, Fixed, 95% CI) |
0.03 [−0.13, 0.20] |
28.2 Baseline FEV1 61-79 % predicted
|
4 |
167 |
Std. Mean Difference (IV, Fixed, 95% CI) |
−0.07 [−0.16, 0.03] |
28.3 Baseline FEV1 <= 60 % predicted
|
1 |
478 |
Std. Mean Difference (IV, Fixed, 95% CI) |
0.03 [−0.15, 0.20] |
28.4 Baseline FEV1 % predicted not reported
|
1 |
469 |
Std. Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
29 % nighttime awakenings at endpoint
|
2 |
2175 |
Mean Difference (IV, Fixed, 95% CI) |
−0.40 [−0.55, −0.25] |
29.1 Baseline FEV1 61-79% predicted
|
2 |
2175 |
Mean Difference (IV, Fixed, 95% CI) |
−0.40 [−0.55, −0.25] |
30 % nights with no awakenings at endpoint
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
30.1 Baseline FEV1 61-79 % predicted
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
31 Change in % nights with no awakenings at endpoint
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
31.1 Baseline FEV1 61-79 % predicted
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
32 Change in # daytime rescue inhalations at endpoint
|
5 |
3455 |
Mean Difference (IV, Random, 95% CI) |
−0.48 [−0.77, −0.20] |
32.1 Baseline FEV1 >= 80 % predicted |
0 |
0 |
Mean Difference (IV, Random, 95% CI) |
Not estimable |
32.2 Baseline FEV1 61-79 % predicted
|
5 |
3455 |
Mean Difference (IV, Random, 95% CI) |
−0.48 [−0.77, −0.20] |
32.3 Baseline FEV1 <= 60 % predicted |
0 |
0 |
Mean Difference (IV, Random, 95% CI) |
Not estimable |
33 Change in # nighttime rescue inhalations at endpoint
|
4 |
2980 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.13 [−0.21, −0.05] |
33.1 Baseline FEV1 61-79 % predicted
|
4 |
2980 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.13 [−0.21, −0.05] |
33.2 Baseline FEV1 <= 60 % predicted |
0 |
0 |
Std. Mean Difference (IV, Random, 95% CI) |
Not estimable |
34 Absolute (or %) change in # rescue inhalations (per 24 hrs) at endpoint
|
12 |
4631 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.20 [−0.29, −0.11] |
34.1 Baseline FEV1 >= 80% predicted
|
4 |
1870 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.14 [−0.23, −0.05] |
34.2 Baseline FEV1 61-79 % predicted
|
6 |
1815 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.26 [−0.35, −0.17] |
34.3 Baseline FEV1 <= 60 % predicted
|
1 |
478 |
Std. Mean Difference (IV, Random, 95% CI) |
−0.42 [−0.60, −0.24] |
34.4 Baseline FEV1 not reported
|
1 |
468 |
Std. Mean Difference (IV, Random, 95% CI) |
0.12 [−0.07, 0.30] |
35 # daytime rescue inhalations (puffs/day) at endpoint
|
5 |
544 |
Mean Difference (IV, Random, 95% CI) |
−0.44 [−0.94, 0.06] |
35.1 Baseline FEV1 >= 80 % predicted
|
2 |
278 |
Mean Difference (IV, Random, 95% CI) |
−0.15 [−0.38, 0.07] |
35.2 Baseline FEV1 61-79 % predicted
|
2 |
242 |
Mean Difference (IV, Random, 95% CI) |
−1.44 [−1.96, −0.93] |
35.3 Baseline FEV1 not reported
|
1 |
24 |
Mean Difference (IV, Random, 95% CI) |
0.04 [−0.28, 0.36] |
36 # nighttime rescue inhalations at endpoint (puffs/day)
|
4 |
941 |
Mean Difference (IV, Random, 95% CI) |
−0.09 [−0.23, 0.04] |
36.1 Baseline FEV1 >=80% predicted
|
2 |
714 |
Mean Difference (IV, Random, 95% CI) |
−0.04 [−0.10, 0.01] |
36.2 Baseline FEV1 61-79 % predicted
|
1 |
203 |
Mean Difference (IV, Random, 95% CI) |
−0.74 [−1.13, −0.35] |
36.3 Baseline FEV1 not reported
|
1 |
24 |
Mean Difference (IV, Random, 95% CI) |
Not estimable |
37 % overall rescue-free days at endpoint
|
3 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
37.1 Baseline FEV1 61-79 % predicted
|
3 |
2516 |
Mean Difference (IV, Random, 95% CI) |
5.14 [−2.79, 13.08] |
38 Change in % symptom-free days at endpoint
|
1 |
|
% (Random, 95% CI) |
−0.24 [−1.20, 0.72] |
38.1 Baseline FEV1 >= 80% predicted |
0 |
|
% (Random, 95% CI) |
Not estimable |
38.2 Baseline FEV1 61% to 79% of predicted
|
1 |
|
% (Random, 95% CI) |
−0.24 [−1.20, 0.72] |
38.3 Baseline FEV1 <= 60% predicted |
0 |
|
% (Random, 95% CI) |
Not estimable |
38.4 Baseline FEV1 % predicted not reported |
0 |
|
% (Random, 95% CI) |
Not estimable |
39 Change in mean % rescue-free days at endpoint
|
3 |
1332 |
Mean Difference (IV, Fixed, 95% CI) |
11.48 [7.98, 14.98] |
39.1 Baseline FEV1 >= 80 % predicted
|
1 |
558 |
Mean Difference (IV, Fixed, 95% CI) |
5.40 [−0.14, 10.94] |
39.2 Baseline FEV1 61% to 79% predicted
|
2 |
774 |
Mean Difference (IV, Fixed, 95% CI) |
15.50 [10.99, 20.02] |
40 Change in asthma control days at endpoint (%)
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
40.1 Baseline FEV1 >= 80 % predicted
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
41 Change in quality of life (AQLQ score) at endpoint
|
4 |
341 |
Mean Difference (IV, Fixed, 95% CI) |
0.10 [−0.06, 0.26] |
41.1 Baseline FEV1 61% to 79 % predicted
|
3 |
323 |
Mean Difference (IV, Fixed, 95% CI) |
0.10 [−0.06, 0.26] |
41.2 Baseline FEV1 not reported
|
1 |
18 |
Mean Difference (IV, Fixed, 95% CI) |
0.18 [−0.72, 1.08] |
42 Change in Hyland QOL at endpoint
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
42.1 Baseline FEV1 >= 80 % predicted
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
43 # Achieving good asthma control
|
1 |
|
Risk Ratio (M-H, Fixed, 95% CI) |
Totals not selected |
43.1 Baseline FEV1 >= 80 % predicted |
0 |
|
Risk Ratio (M-H, Fixed, 95% CI) |
Not estimable |
43.2 Baseline FEV1 61% to 79 % predicted
|
1 |
|
Risk Ratio (M-H, Fixed, 95% CI) |
Not estimable |
43.3 Baseline FEV1 <= 60 % predicted |
0 |
|
Risk Ratio (M-H, Fixed, 95% CI) |
Not estimable |
44 % asthma control days at endpoint
|
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
44.1 Baseline FEV1 61% to 79 % predicted
|
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
45 Serum ECP( microg /L)
|
2 |
87 |
Mean Difference (IV, Fixed, 95% CI) |
0.62 [−2.45, 3.70] |
45.1 Baseline FEV1 >= 80% predicted
|
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
−0.70 [−4.51, 3.11] |
45.2 Baseline FEV1 61% to 79 % predicted
|
1 |
39 |
Mean Difference (IV, Fixed, 95% CI) |
3.10 [−2.11, 8.31] |
46 Plasma cortisol ( nmol/L) 8am at 8 weeks
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
46.1 Baseline FEV1 61% to 79 % predicted
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
47 Tidal exhaled NO(ppb)
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
47.1 Baseline FEV1 61% to 79 % predicted
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
48 PD20 @ 8 weeks
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
48.1 Baseline FEV1 61% to 79 % predicted
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
49 PC20
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
49.1 Baseline FEV1 not reported
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
50 Change in mean urine Cortisol/Creatinine ratio
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
50.1 Baseline FEV1 61% to 79 % predicted
|
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
51 Change in PC20 |
0 |
|
Doubl’g doses (Fixed, 95% CI) |
Totals not selected |
51.1 Baseline FEV1 >= 80 % predicted |
0 |
|
Doubl’g doses (Fixed, 95% CI) |
Not estimable |
51.2 Baseline FEV1 61% to 79 % predicted |
0 |
|
Doubl’g doses (Fixed, 95% CI) |
Not estimable |
51.3 Baseline FEV1 <= 60 % predicted |
0 |
|
Doubl’g doses (Fixed, 95% CI) |
Not estimable |
51.4 Baseline FEV1 not reported |
0 |
|
Doubl’g doses (Fixed, 95% CI) |
Not estimable |
52 Serious adverse events
|
35 |
13640 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.12 [0.91, 1.37] |
52.1 Baseline FEV1 >= 80 % predicted
|
6 |
2345 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.82 [0.50, 1.34] |
52.2 Baseline FEV1 61% to 79% predicted
|
18 |
7978 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.23 [0.97, 1.56] |
52.3 Baseline FEV1 <= 60 % predicted
|
1 |
488 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.38 [0.44, 4.28] |
52.4 Baseline FEV1 not reported
|
10 |
2829 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.77 [0.35, 1.72] |
53 # patients with tremor
|
11 |
5562 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.84 [1.20, 2.82] |
53.1 Baseline FEV1 >= 80 % predicted
|
1 |
233 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.15 [0.01, 2.90] |
53.2 Baseline FEV1 61% to 79 % predicted
|
9 |
4841 |
Risk Ratio (M-H, Fixed, 95% CI) |
2.03 [1.29, 3.19] |
53.3 Baseline FEV1 <= 60% predicted
|
1 |
488 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.97 [0.18, 21.56] |
54 # patients with oral thrush
|
14 |
7727 |
Risk Ratio (M-H, Random, 95% CI) |
0.58 [0.40, 0.86] |
54.1 Baseline FEV1 >= 80 % predicted
|
3 |
1427 |
Risk Ratio (M-H, Random, 95% CI) |
0.38 [0.14, 1.05] |
54.2 Baseline FEV1 61-79 % predicted
|
9 |
5329 |
Risk Ratio (M-H, Random, 95% CI) |
0.74 [0.44, 1.24] |
54.3 Baseline FEV1 <= 60 % predicted
|
1 |
488 |
Risk Ratio (M-H, Random, 95% CI) |
0.33 [0.13, 0.81] |
54.4 Baseline FEV1 predicted not reported
|
1 |
483 |
Risk Ratio (M-H, Random, 95% CI) |
0.50 [0.05, 5.45] |
55 Total # adverse events
|
30 |
11483 |
Risk Ratio (M-H, Random, 95% CI) |
0.99 [0.95, 1.03] |
55.1 Baseline FEV1 >= 80 % predicted
|
7 |
2634 |
Risk Ratio (M-H, Random, 95% CI) |
0.99 [0.90, 1.09] |
55.2 Baseline FEV1 61-79 % predicted
|
17 |
7326 |
Risk Ratio (M-H, Random, 95% CI) |
0.99 [0.93, 1.05] |
55.3 Baseline FEV1<=60 % predicted
|
1 |
488 |
Risk Ratio (M-H, Random, 95% CI) |
1.03 [0.95, 1.11] |
55.4 Baseline FEV1 predicted not reported
|
5 |
1035 |
Risk Ratio (M-H, Random, 95% CI) |
0.94 [0.83, 1.07] |
56 # patients with adverse cardiovascular events
|
9 |
3439 |
Risk Ratio (M-H, Random, 95% CI) |
0.99 [0.49, 2.01] |
56.1 Baseline FEV1 >= 80 % predicted
|
1 |
233 |
Risk Ratio (M-H, Random, 95% CI) |
0.27 [0.03, 2.34] |
56.2 Baseline FEV1 61% to 79 % predicted
|
7 |
2718 |
Risk Ratio (M-H, Random, 95% CI) |
1.04 [0.47, 2.29] |
56.3 Baseline FEV1 <= 60% predicted
|
1 |
488 |
Risk Ratio (M-H, Random, 95% CI) |
2.95 [0.31, 28.17] |
57 # patients with headache
|
25 |
10824 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.02 [0.92, 1.12] |
57.1 Baseline FEV1 >= 80 % predicted
|
6 |
2179 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.11 [0.96, 1.28] |
57.2 Baseline FEV1 61% to 79 % predicted
|
15 |
7070 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.94 [0.82, 1.07] |
57.3 Baseline FEV1 <= 60 % predicted
|
1 |
488 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.23 [0.70, 2.15] |
57.4 Baseline FEV1 predicted not reported
|
3 |
1087 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.26 [0.70, 2.26] |
58 # patients with hoarseness
|
9 |
4963 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.95 [0.79, 1.14] |
58.1 Baseline FEV1 >/= 80% predicted
|
2 |
646 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.00 [0.82, 1.22] |
58.2 Baseline FEV1 61% to 79 % predicted
|
4 |
2957 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.86 [0.54, 1.36] |
58.3 Baseline FEV1 <= 60% predicted
|
1 |
488 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.98 [0.43, 2.23] |
58.4 Baseline FEV1 predicted not reported
|
2 |
872 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.62 [0.16, 2.37] |
59 # patients with tachycardia or palpitations
|
15 |
7284 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.20 [0.78, 1.84] |
59.1 Baseline FEV1 >= 80 % predicted
|
1 |
233 |
Risk Ratio (M-H, Fixed, 95% CI) |
0.15 [0.01, 2.90] |
59.2 Baseline FEV1 61% to 79 % predicted
|
11 |
5691 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.11 [0.61, 2.02] |
59.3 Baseline FEV1 <= 60 % predicted
|
1 |
488 |
Risk Ratio (M-H, Fixed, 95% CI) |
6.89 [0.36, 132.62] |
59.4 Baseline FEV1 predicted not reported
|
2 |
872 |
Risk Ratio (M-H, Fixed, 95% CI) |
1.39 [0.70, 2.74] |
60 Growth (paediatric data)
|
1 |
|
cm (Random, 95% CI) |
Totals not selected |