Abstract
Aim: To evaluate the efficacy and safety profile of ciclesonide (CIC) in the treatment of persistent allergic or non-allergic asthma in a real-life setting in Austria.
Methods: 307 patients suffering from persistent asthma of any severity grade (42% treatment-naive) were enrolled in this non-interventional study (NIS). After prescription of CIC (most frequently 160µg/d) patients were observed for 3 months. At study start 85% were prescribed concomitant medication, primarily short-acting ß2-agonists. Efficacy was evaluated by FEV1, Asthma Control Questionnaire (ACQ), Asthma Quality of Life- (AQLQ(S)), asthma symptoms, physical activity limitations and use of rescue medication.
Results: Mean FEV1 % predicted increased from 75.1±15.4% to 83.7±14.9%. At the end of the observation period, the percentage of patients with daily symptoms had declined from 33.2% to 3.9%, nighttime symptoms from 21.8% to 5.2%, physical activity limitations from 73.9% to 24.4%, and rescue medication usage from 70.0% to 29.3%. The mean total ACQ score was 2.32 ± 1.14 at baseline and 1.08 ±0.88 at study end. The number of patients with well-controlled asthma (ACQ-score <1) increased considerably from 11.0% to 52.2%. Accordingly, clinically important mean improvements were observed in the total self-assessed AQLQ(S) score. A low incidence of adverse drug reactions (ADR) was observed (4 ADRs in 3/307 patients).
Conclusion: This NIS in patients with persistent asthma confirmed the efficacy and safety of CIC in routine clinical care showing improvements in symptom control, lung function, and quality of life. CIC was well tolerated in this heterogeneous patient population.
- © 2012 ERS