Skip to main content
. Author manuscript; available in PMC: 2014 Sep 21.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Apr 14;(4):CD005533. doi: 10.1002/14651858.CD005533.pub2

Comparison 1.

LABA + ICS versus higher dose ICS

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
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