Criteria for selecting an ICS for OCS-sparing therapy must include improved safety, with respect to both systemic and local AEs. The safety profile of an ICS is influenced by many factors, including the degree of systemic bioavailability. Suppression of HPA-axis function and adrenal insufficiency are indicative of a higher degree of systemic bioavailabil-ity and are […]
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 […]
HPA-Axis Evaluation: Unstimulated (basal) mean serum cortisol levels increased significantly from baseline to end point in the CIC640 group (3.58 ^g/dL [SE 0.97]; 95% CI, 1.66 to 5.51) and the CIC1280 group (2.34 ^g/dL [SE 1.01]; 95% CI, 0.33 to 4.35). Cortisol levels within the placebo group also rose but not significantly (1.33 ^g/dL [SE […]
Greater baseline to end point improvements were also observed in mean morning PEF scores in both ciclesonide groups (CIC640, 4.32 L/min [SE 6.55]; CIC1280, 15.97 L/min [SE 6.50]) compared with placebo (-0.7 L/min [SE 6.86]); this improvement from baseline was statistically significant in the CIC1280 group (95% CI, 3.10 to 28.84). Symptoms and Rescue Medication […]
Reduction in Prednisone Dose: At end point, the mean oral prednisone dose was lower in the ciclesonide groups compared with placebo (CIC640, 8.60 ^g/d; CIC1280, 4.66 ^g/d; placebo, 13.63 ^g/d). Mean use was reduced by 47.39% (SE 10.10; 95% confidence interval [CI] – 67.40 to – 27.38) and 62.54% (SE 9.80; 95% CI, – 81.94 […]
The trial was conducted between July 2001 and March 2003. Overall, 241 patients were screened, and 141 patients (80 in the United States and 61 in South Africa) were randomized to receive treatment at 60 sites within these countries (CIC640, n = 47; CIC1280, n = 49; placebo, n = 45). Patient disposition throughout the […]
The investigators assessed patients for AEs; in addition, patients reported AEs in their patient diaries. Data from physical examinations and clinical laboratory tests were collected at screening and week 12. HPA-axis function was assessed at randomization and at week 12 via cosyntropin stimulation. Blood samples for serum cortisol measurements were collected before and after stimulation […]