evening administration of ciclesonide 320 mcg and budesonide 400 mcg, onset of treatment effect as evidenced by daily recordings of morning PEF was observed on day 3 with ciclesonide compared with week 2 with budesonide (Biberger et al. 2003). Differences between ciclesonide and active control were not statistically significant. Similarly, maintenance of pulmonary function with ciclesonide 160 mcg (dosed either in the morning or evening) was not statistically different with budesonide 200 mcg twice daily (Niphadkar et al. 2005). However, an 8-week study reported in abstract form reported a significant difference (P=0.001) in PEF in favour of ciclesonide 320 mcg twice daily compared with budesonide 400 mcg twice daily (Adachi et al. 2006). These results are predominantly obtained from studies of 12 weeks’ duration. In a 40-week open-label extension of a 12-week double-blind study evaluating ciclesonide 800 mcg/day and 1600 mcg/day, the improvement in FEV1 was sustained throughout the study period (O'Connor et al. 2002). Over a 52-week study period, FEV1 increased significantly over baseline in patients treated with ciclesonide 200 mcg/day (P=0.0072) and 800 mcg/day (P=0.0237) (Chapman et al. 2002). Finally, ciclesonide 640 mcg twice daily was as effective as oral prednisolone 40 mg once daily in improving lung function in 130 patients with acute asthma exacerbation, without causing HPA suppression (Postma et al. 2006). Use of oral corticosteroids Since the regular use of oral corticosteroids is associated with significant adverse systemic effects, the impact of inhaled corticosteroid therapy on daily oral corticosteroids required to control symptoms in patients with persistent asthma is an important measure of efficacy. Use of inhaled corticosteroids has been associated with a reduction in the use of oral corticosteroids (Larj & Bleecker 2004). In a 12-week trial of 141 patients with severe, persistent asthma, use of ciclesonide significantly reduced the need for oral corticosteroid at doses of 320 or 640 mcg twice daily compared with placebo. Mean percentage change in oral corticosteroid use from baseline was –47.39 (low-dose ciclesonide, P=0.0003 vs placebo), –62.54 (high-dose ciclesonide, P=0.0001 vs placebo), and +4.2 (placebo) (Bateman et al. 2006b). Asthma symptom score and use of rescue medications Evidence from large controlled trials that have evaluated ciclesonide and either placebo or a comparator drug indicate that ciclesonide is at least as effective in reducing patient-reported asthma symptoms and use of rescue medications (Table 7). For example, daily albuterol use as rescue medication was reduced significantly in all ciclesonide-treated groups (80, 160, and 320 mcg) but increased in the placebo group (Pearlman et al. 2005). A dose–response effect has been demonstrated, with half as many patients receiving ciclesonide 320 mcg twice daily experiencing an asthma exacerbation compared with those taking ciclesonide 160 mcg/day (23 [6.7%] vs 43 [12.7%] patients) (Bateman et al. 2006a). The higher dose was also Core Evidence 2006;1(4) Ciclesonide | place in therapy review associated with significantly lower use of rescue medication (P=0.0005) and improved symptom scores (P=0.0108) than the lower dose. In one study comparing inhaled doses of ciclesonide 80 mcg once daily, ciclesonide 160 mcg once daily, and fluticasone propionate 88 mcg twice daily in patients with mild-to-moderate persistent asthma, the percentage of days without asthma symptoms and without the need for rescue medications (84–87% for mild disease; 70–79% for moderate disease) was similar for all treatment groups and was highest during the last 4 weeks of the 12-week study (Magnussen et al. 2005). This increase in the last 4 weeks of a 12- week trial was also observed by Buhl et al. (2005b). The percentage of symptom-free days was higher in those patients treated with ciclesonide (91%) than in patients treated with fluticasone (83%, significance not reported), although the percentage of days not requiring rescue medication was comparable (89 vs 91%, respectively) (Buhl et al. 2005b). A full publication of this study by the same authors reported comparable changes in asthma symptom scores for ciclesonide and fluticasone (reductions of 0.75 and 0.86, respectively) (Buhl et al. 2005a). Ciclesonide 320 mcg once daily was comparable to fluticasone 200 mcg twice daily in percentage of days without symptoms (88% both groups) or use of rescue medication (85 and 84%, respectively) after 12 weeks in 472 patients with moderate asthma (Boulet et al. 2006b). Bateman et al. (2006c) adds to the evidence that ciclesonide is equivalent in efficacy to fluticasone. Patients treated with ciclesonide 160 mcg (dosed either in the morning or in the evening) or budesonide 200 mcg twice daily experienced equivalent periods of symptom-free days (89, 91, and 93%, respectively) (Niphadkar et al. 2005). In addition, other outcomes including rescue medication use, days with control of asthma symptoms, and days without PEF fluctuation were maintained versus baseline with no significant differences between the three groups. In contrast, Adachi et al. (2006) reported significantly lower use of rescue medication (P=0.007) and improved symptom scores (P=0.008) with ciclesonide 320 mcg twice daily compared with budesonide 400 mcg twice daily after 8 weeks’ treatment in 319 patients with moderate to severe asthma. Similarly, although overall judged as having comparable efficacy, ciclesonide 320 mcg once daily resulted in significantly more symptom-free days compared with budesonide 320 mcg once daily in 359 patients with persistent asthma (Boulet et al. 2006a). Use in children The efficacy of ciclesonide in children has been compared with placebo, budesonide, and fluticasone. In a large double-blind, randomized trial involving 1031 children aged 4 –11 years, mean FEV1 percent predicted increased by 11.97, 13.58, and 14.17, and mean absolute FEV1 increased by 250, 280, and 290 mL versus placebo after 12 weeks’ treatment with ciclesonide 40, 80, and 160 mcg once daily, respectively (Gelfand et al. 2006). Morning and evening PEF also increased, the latter by 12.27, 18.34, and 15.78 L/min. The changes seen with ciclesonide 80 and 160 mcg/day were significant versus 241