Ciclesonide | place in therapy review Table 6 | Effect on lung function of ciclesonide compared with active treatment in patients aged >12 years with moderate to severe asthma (level 2 evidence; all trials double-blind unless stated) FEV1 (mL) FEV1 (%) change from baseline FVC (mL) Morning PEF (L/min) Evening PEF (L/min) Outcome Increase in both groups (no values given); CIC>BUD (P=0.0359) +530c +499c +5d (P=0.905) +2d (P=0.970) 0 NR NR NR NR NR NR –120 (P=0.01 vs BUD) –3c –210 –10c –4.4d (P=0.464) +9.3d (P=0.131) 0 –1.1d (P=0.855) +4.0d (P=0.490) 0 +16c +24c (P=0.001 vs BUD) +6c NR +33c +36c 18.11c 20.71c 31.73c –9.69c +36c +22c NR +12c +17c +21c +52c +53c NR NR NR NR –2c –4c NR NR NR Similar to morning PEF (data shown graphically) Reference Biberger et al. 2003 Buhl et al. 2005a Niphadkar et al. 2005 Weinstein et al. 2005 Adachi et al. 2006 Bateman et al. 2006c Boulet et al. 2006a Boulet et al. 2006b Hansel et al. 2006 Postma et al. 2006 Treatment (mcg) n [duration] CIC 320 qd BUD 400 qd [12 w] CIC 160 qd FP 88 bid [12 w] CIC 160 qd A CIC 160 qd P BUD 200 bid [12 w] CIC 160 bid CIC 320 bid FP 440 bidb Placebo [12 w] CIC 320 qd CIC 320 bid BUD 400 bid [8 w] CIC 320 bid FP 330 bid [24 w] CIC 320 qd BUD 320 qd [12 w] CIC 320 qd FP 200 bid [12 w] CIC 80 qd CIC 320 qd BUD 200 bid [12 w] CIC 640 bid PRED 40 mg qd [2 w] 240 399a 266 263 139 131 133 179 180 182 195 177 130a 531a 54 319a,e NR 528a,e ≥80 472a,e 60–80 65–95 73c 72c 72c NR Baseline FEV1 (% of predicted) 50–90 80–100 ≥70 +411c +319c CIC>BUD (P=0.0374) +489c +499c –36d (P=0.383) +22d (P=0.598) 0 NR NR +11 +38 –170 –220 +171 +186 +267c +256c +355c +429 +428 NR +20.45 +20.4 NR +21.24c +24.46c +30.09c NR NR –6 –8 NR +10.8 +10.4 +14.4 NR aNumbers of patients in each group not specified. bFP dose 37% higher to maintain blinding. cReported as a mean value. dLeast squares mean vs budesonide; intent-to-treat analysis. eOpen-label design. +, increase; –, decrease; A, AM; bid, twice daily; BUD, budesonide; CIC, ciclesonide; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; FP, fluticasone propionate; NR, not reported; P, PM; PRED, prednisolone; PEF, peak expiratory flow; qd, once daily; w, week. © 2006 Core Medical Publishing Limited