Efficacy and Safety of Inhaled Ciclesonide Compared with Chlorofluorocarbon Beclomethasone Dipropionate in Adults with Moderate to Severe Persistent Asthma

Background and objective: Inhaled corticosteroids are recognized as first‐line therapy in the management of asthma; however, their use may be limited by systemic and local side‐effects. Ciclesonide, a novel pro‐drug inhaled corticosteroid, is activated in the lungs and is expected to have less systemic and local side‐effects. This study evaluated the efficacy and safety of ciclesonide in hydrofluoroalkane (HFA) compared with beclomethasone dipropionate (BDP) in a chlorofluorocarbon (CFC) formulation in adult patients with moderate to severe asthma.Methods: This was a multicentre, randomized, open‐label, parallel‐group comparative study. The patients were given 800 μg/day of CFC‐BDP in the four‐week baseline period. After the baseline period, 319 patients were randomly allocated into three groups which, respectively, received HFA‐ciclesonide 400 μg/day (without a spacer), HFA‐ciclesonide 800 μg/day (without spacer) and CFC‐BDP 800 μg/day (with spacer) for the eight‐week treatment period. The primary efficacy variable was morning PEF.Results: The morning PEF increased by 16.02 L/min in the 400 μg HFA‐ciclesonide group, 23.98 L/min in the 800 μg HFA‐ciclesonide group and 5.91 L/min in the 800 μg CFC‐BDP group. Better outcomes were achieved by the use of 800 μg/day of HFA‐ciclesonide compared with 800 μg/day of CFC‐BDP (P = 0.001). There was no difference in adverse events between the groups.Conclusion: In adult patients with moderate to severe asthma, 800 μg/day of HFA‐ciclesonide was significantly more effective than 800 μg/day of CFC‐BDP. Ciclesonide at doses of 400 μg/day and 800 μg/day was safe and well tolerated.