Ciclesonide Reduces the Need for Oral Steroid Use in Adult Patients With Severe, Persistent Asthma: Research
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 Use: There were no significant between-treatment differences in baseline to end point changes in mean 24-h asthma symptom scores (CIC640, 0.1 [SE 0.22]; CIC1280, -0.31 [SE 0.21]; placebo, -0.24 [SE 0.23]) or in mean daily albuterol use (CIC640, – 0.07 puffs per day [SE 0.51]; CIC1280, -0.08 puffs per day [SE 0.51]; placebo, 0.32 puffs per day [SE 0.54]) in any of the treatment groups. website
Discontinuation Due to Lack of Efficacy: A total of 114 patients (80.9%) completed the study. There was a significant difference across the treatment groups with regard to the number of patients who discontinued prematurely due to a lack of efficacy; the withdrawal rate was significantly higher in the placebo group (CIC640, 6 patients [12.8%]; CIC1280, 3 patients [6.3%]; placebo, 13 patients [28.9%]; p = 0.0108) [Fig 5].
AEs: Overall, both ciclesonide doses were well tolerated during the 12 weeks of therapy; however, 14.9%, 8.2%, and 26.7% of patients in the CIC640, CIC1280, and placebo groups, respectively, discontinued the study due to treatment-emergent AEs (TEAEs), the most common of which, across all treatment groups, was worsening asthma. A higher percentage of patients in the placebo group had at least one TEAE compared with the ciclesonide groups (CIC640, 85.1%; CIC1280, 79.6%; placebo, 88.9%). Over 12 weeks, 17.0%, 14.3%, and 22.2% of patients in the CIC640, CIC1280, and placebo groups, respectively, reported at least one TEAE that was considered possibly related to the study medication. Eight patients (CIC640, four patients [8.5%]; CIC1280, two patients [4.1%]; placebo, two patients [4.4%]) had a serious TEAE, none of which were considered possibly related to the study medication. There were no deaths during the study. Local TEAEs that were possibly related to the study medication included hoarseness (CIC640, three patients [6.4%]; CIC1280, zero patients [0%]; placebo, one patient [2.2%]); pharyngitis (CIC640, one patient [2.1%]; CIC1280, zero patients [0%]; placebo, three patients [6.7%]); and oral candidiasis (CIC640, three patients [6.4%]; CIC1280, four patients [8.2%]; placebo, zero patients [0%]). Overall, the percentage of patients with possibly related TEAEs was lower in the ciclesonide treatment groups (CIC640, 17.0%; CIC1280, 14.3%) than in the placebo-treated group (22.2%).
Figure 5. Kaplan-Meier plot of patient discontinuation from the study due to a lack of efficacy in patients with severe asthma receiving treatment with ciclesonide, 320 ^g/d bid (CIC640); ciclesonide, 640 |j,g/d bid (CIC1280); or placebo. p = 0.0108 for both CIC640 and CIC1280 treatment groups compared with placebo. See Figure 2 legend for expansion of abbreviation.