Personalization of therapy for mild asthma in adolescents to achieve control: a multicenter study of ciclesonide in real clinical practice

In real-world clinical practice, mild asthma is the most common type of asthma but selection of the basic therapy for these patients can present certain challenges. Monotherapy with inhaled corticosteroids (ICS) in the form of finely dispersed metered-dose aerosols (e.g., ciclesonide) may prove highly effective in adolescents with poorly controlled mild asthma.

The aim of this multicenter, open-label study was to evaluate the efficacy of ciclesonide in different dosing regimens for achieving and maintaining asthma control in adolescents with initially uncontrolled asthma.

Methods. An open, prospective, non-comparative study lasting 90 ± 7 days included patients (n = 129: 69.8% boys; mean age 14.2 ± 1.7 years) with uncontrolled mild atopic asthma (household, epidermal sensitization, and tree pollen in some patients) in 14 centers. The patients received background therapy with ciclesonide 160 μg per day. Asthma control tests (Global Initiative for Asthma (GINA) questionnaires and the Asthma Control Test (ACT) were completed at 3 visits. The number of asthma exacerbations, days with use of emergency medications and/or school absences due to asthma symptoms, and adverse events were taken into account. Spirometry with a salbutamol challenge was performed, and absolute eosinophil blood counts were measured at Visits 1 and 3. Subanalyses were performed for the subgroups of patients who were switched to ciclesonide 80 μg/day at Visit 2 (n = 26) by the treating physician and for those with tree pollen allergy (n = 49).

Results. The proportion of individuals with controlled asthma increased with regular ciclesonide treatment: 94 (77.7%) at Visit 2 and 111 (95.7%) at Visit 3. No significant differences in asthma control criteria were found between the groups with and without tree pollen allergy. When comparing spirometric indices at Visits 1 and 3, the proportion of patients whose baseline forced expiratory volume in 1 second was > 80% of predicted value increased to 100% (p = 0.026 compared to Visit 1 – 34.6%), and the proportion of individuals with a negative result in the salbutamol test increased to 83.6% (p = 0.0001 compared to Visit 1 – 12.4%). No changes in blood eosinophil content were shown between Visits 1 and 3 (Me (Q25; Q75)): 310 (180; 500) and 290 (150; 450) cells/μl. The results of questionnaires, spirometry and the number of emergency inhalations showed maintained asthma control in the subgroup of patients who received ciclesonide at a dose of 80 μg per day after Visit 2. No adverse events of clinical significance or requiring discontinuation of ciclesonide were reported.

Conclusion. Background therapy with ciclesonide (Asmalib® Air, metered-dose aerosol for inhalation, LLC PSK Pharma, Russia) in adolescents has a positive effect on asthma control (assessed using the ACT and GINA) and spirometry results. A reduction in the frequency of rescue medication inhalations was also noted.

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