Prof. Dr. Otto Chris Burghuber, Dr. Gerhard Köberl, Dr. Susanna Lenk-Feik, and Dr. Monika Schantl: on behalf of the ATEM study group in Austria.
This study was funded by Takeda Pharma Ges.m.b.H (previously Nycomed Pharma GmbH).
Clinical Trial Registration Number: NCT01147224.
Effectiveness and safety profile of ciclesonide in the treatment of persistent allergic or non-allergic asthma was evaluated in real-life setting in Austria.
Prospective, single-arm, 3-month observational, non-interventional, open-label cohort study in patients with persistent asthma (with or without allergic component) of any severity grade was conducted. Patients were either treatment naïve or switched to treatment with ciclesonide and had an indication for treatment with inhaled corticosteroids.
In all, 307 patients (50.8 % female; mean age, 45.7 years) were prescribed ciclesonide. After 3 months of observation, the percentage of patients with daily symptoms had declined from 33.2 to 3.9 %, night-time symptoms from 21.8 to 5.2 %, physical activity limitations from 73.9 to 24.4 %, and rescue medication usage from 70.0 to 45.9 %. The mean total Asthma Control Questionnaire (ACQ) score was 2.32 ± 1.14 at the first and 1.08 ± 0.88 at the final visit. The number of patients with well-controlled asthma (ACQ score < 1) increased considerably from 11.0 % at baseline to 52.2 % at study end. Clinically important mean improvements were observed in the total self-assessed Asthma Quality of Life score and all four domain scores. The mean forced expiratory volume in 1 s (FEV1) increased by 0.3 L from 2.60 ± 0.87 L to 2.89 ± 0.86 L, and the mean FEV1% predicted increased from 75.1 ± 15.4 % to 83.7 ± 14.9 %. Incidence of adverse drug reactions (ADRs) was low (4 ADRs in 3 of 307 patients, or 1.0 %).
This study confirmed the effectiveness and safety of ciclesonide under routine conditions in Austria. Improvements in symptom control, lung function, and quality of life were observed. Ciclesonide was well tolerated.