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. 2008 Apr 23;2008(2):CD006217. doi: 10.1002/14651858.CD006217.pub2

Comparison 2. Ciclesonide versus placebo 200mcg/d (ex‐valve, parallel group studies).

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