Ciclesonide Reduces the Need for Oral Steroid Use in Adult Patients With Severe, Persistent Asthma: Conclusion

The potential benefit of this switch to ciclesonide from other forms of ICS on the long-term AEs of OCS is suggested by evidence implying diminished HPA-axis suppression in patients who received ciclesonide. Conversely, a larger proportion of patients receiving placebo had HPA-axis suppression. These and other potential benefits of the oral steroid-sparing effects of ciclesonide will need to be confirmed in longer-term clinical studies. Compared with this study, other published OCS-sparing studies using the ICS fluticasone propionate and budesonide have reported larger reductions in prednisone usage and higher prednisone discontinuation rates. However, a comparison of the results of such studies is hampered by differences in the patient populations and study designs. In particular, there are differences in the method of ensuring that patients are receiving a minimum effective dose of OCS before the initiation of the study treatments, and in the procedure for reducing the dose of OCS throughout the study. Both the size of the dosage steps and the duration of each step may influence the results. Sufficient time must be allowed between dose reductions to permit evaluation of the full effects of each change in treatment. there

The step-down approach used to establish the minimum effective OCS dose in this study is identical to that used by Fish et al to evaluate the effect of mometasone furoate. The rapid (weekly) step-down routine is based on criteria for asthma control that, although not ideal (ie, do not represent complete control as recommended in guidelines), may be considered satisfactory when viewed against the potential harm caused by prolonged use of OCS. The same criteria and dosing steps were used during the active treatment phase. This approach is slow enough to ensure little carryover of efficacy between the doses but rapid enough to avoid seasonal and other temporal factors that influence asthma control.

In a study by Nelson et al, who examined the OCS-sparing effect of fluticasone propionate in patients with severe asthma, the minimal effective dose was not established at baseline, and all patients entered the study receiving the same dose of OCS as they were at recruitment. Additionally, the screening period in the study by Nelson et al was only 2 weeks, rather than 4 weeks as in our current study. In a second study involving budesonide, all patients had their OCS dose increased at baseline, calling into question the significance of the reductions in OCS dosage that were achieved later in the study.