D3.161 - Efficacy and Safety of Ciclesonide in Achieving Asthma Control: Results of an Observational Multicenter Study in Real-World Clinical Practice

Small airway involvement plays an important role in asthma pathogenesis. Inflammatory changes in small airways impede achievement of disease control. Ciclesonide is a fine-particle inhaled corticosteroid (ICS) with high pulmonary deposition; more than 50% of the drug is distributed to the distal airways. The drug is characterized by absence of systemic effects and low frequency of local adverse effects, making it a promising agent for asthma maintenance therapy. The aim of the study to evaluate the efficacy and safety of ciclesonide 160 mcg (pressurized metered-dose inhaler, pMDI) in achieving and maintaining asthma control in adult patients with previously uncontrolled disease at treatment steps 1-2 in real-world clinical practice.

Open-label, observational, prospective, multicenter study. Thirty-five patients with atopic mild partially controlled or uncontrolled asthma were enrolled; 30 participants completed the study per protocol, 5 participants discontinued (2 due to adverse events, 3 due to poor adherence). Demographic characteristics: mean age 36.86±15.16 years, 17 males (56%), 13 females (43%), 9 smokers (30%), including 4 dual users (cigarettes and electronic nicotine delivery systems). Disease severity: mild asthma – 73%, moderate – 26%. Baseline therapy: SABA – 40%, ICS/LABA as needed – 30%, ICS monotherapy – 20%. Laboratory parameters were determined in 20 patients: eosinophils 378.5±230.8 cells/μL, IgE 465.2±441.2 IU/ml. Patients received ciclesonide 160 mcg once daily by inhalation for 12 weeks. Follow-up visits were conducted on days 28, 56, and 82. Asthma Control Test (ACT), GINA symptom control questionnaire, and FEV₁ (at visits 1 and 4) were assessed. Statistical analysis included paired t-test, Wilcoxon test, and repeated measures ANOVA, Mauchly's test, and Greenhouse-Geisser test with calculation of estimated marginal means and 95% confidence intervals.

Ciclesonide therapy resulted in statistically significant improvement in asthma control. ACT scores increased from 17.03±2.83 to 21.07±2.83 points (p=0.021, SD=19.317, 95% CI 18.459 to 20.175). According to the GINA questionnaire (n=20), mean score decreased from 3.3 to 2.8, corresponding to controlled or partly controlled asthma. FEV₁ increased from 81.05±12.88% to 88.95±11.03% predicted, mean increase was 7.5% (p<0.0001). In the smoking subpopulation (n=9), ACT scores increased from 15.67±1.5 to 19.4±2.24 points (p=0.612, SD=17.722, 95% CI 16.567 to 18.877), FEV₁ increased from 78% to 83%, mean increase 8.33% (p<0.05). One mild asthma exacerbation related to the pollen season was recorded. Adverse events: headache (n=1), impaired sputum expectoration (n=1), transient dry mouth (n=1, without drug discontinuation).

Ciclesonide 160 mcg demonstrates high efficacy and safety in maintenance therapy of mild uncontrolled asthma in real-world clinical practice. The fine-particle structure of the drug provides targeting of peripheral airways, leading to significant improvement in disease control and functional parameters. Positive dynamics in the smoking subpopulation indicates the potential of ciclesonide use in this patient category.