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

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 to -43.14) in patients in the CIC640 and CIC1280 groups, respectively, compared with an increase in the placebo group of 4.21% (SE 10.34; 95% CI, – 16.27 to 24.68) at end point. For both doses of ciclesonide, the differences vs placebo were statistically significant (Fig 2). Although the CIC1280 group had a larger percentage reduction in prednisone dose than the CIC640 group, this difference (15.15% [SE 13.80]; 95% CI, – 42.48 to 12.18) was not statistically significant (p = 0.274; Fig 2). read more

Patients in both ciclesonide treatment groups were able to reduce their prednisone dose as early as week 2 of the study, and this reduction was sustained for the study duration. Overall, 74.4% of patients treated with CIC640 and 85.4% of patients treated with CIC1280 were able to reduce or discontinue prednisone, compared with 40% of patients in the placebo group (Fig 3). Almost one third of patients receiving ciclesonide (29.8% and 31.3% in the CIC640 and CIC1280 groups, respectively) were able to discontinue their use of prednisone entirely, compared with 11.1% of patients receiving placebo (p = 0.0386 and p = 0.0233 for the CIC640 and CIC1280 groups, respectively, vs placebo). An increase in prednisone use was observed in 23.4% and 10.4% of patients in the CIC640 and CIC1280 groups, respectively, at the end of the study, compared with 53.3% of patients in the placebo group. Pulmonary Function: There was no significant change from baseline in FEV1 for either ciclesonide treatment group; however, both groups showed a trend toward higher FEV1 values. In contrast, FEVj values worsened significantly from baseline to end point in the placebo group (95% CI, – 0.24 to – 0.02). The between-treatment differences in FEVj were statistically significant vs placebo for the CIC1280 group (p = 0.0277; 95% CI, 0.02 to 0.31) and the CIC640 group (p = 0.0237; 95% CI, 0.02 to 0.31) [Fig 4].

Figure 2. Mean percentage change in prednisone dose from baseline to study end in patients with severe, persistent asthma receiving treatment with ciclesonide, 320 |j,g bid (CIC640); ciclesonide, 640 |j,g bid (CIC1280); or placebo (PBO). *p = 0.0003 vs placebo. fp = 0.0001 vs placebo.

Figure 3. The distribution of patients in the ITT population grouped by percentage change in prednisone use at the end of the study, after treatment with ciclesonide, 320 |j,g bid (CIC640); ciclesonide, 640 |j,g bid (CIC1280); or placebo. CIC640, p s 0.05; CIC1280, p = 0.0001 both vs placebo at the end of the study. Note that a percentage of patients showed no change in prednisone use at the end of study: 6.7% of patients from the placebo group, 2.1% of patients from the CIC640 group, and 4.2% of patients from the CIC1280 group. See Figure 2 legend for expansion of abbreviation.

Figure 4. Mean (SE) change in FEV1 over 12 weeks from baseline to end of study (last observation carried forward) in patients with severe asthma receiving treatment with ciclesonide, 320 |j,g bid (CIC640); ciclesonide, 640 |j,g bid (CIC1280); or placebo. See Figure 2 legend for expansion of abbreviation. p < 0.03 for both the CIC640 and CIC1280 treatment groups vs placebo at week 12; BL = baseline; EOS = end of study).