title: The safety profile of ciclesonide in the treatment of persistent asthma.
abstract: Inhaled corticosteroids (ICSs) are considered the most effective therapy currently available for persistent asthma and is the guideline-recommended first-line treatment for all patients requiring controller medication; however, the potential for oropharyngeal and systemic adverse events can be a barrier to their use. Ciclesonide (CIC) is a new ICS with a unique pharmacologic profile that may confer a favorable safety profile. This study was designed to provide a comprehensive review of currently available safety data for CIC in adults and children with asthma of all severities. The literature was reviewed for all clinical trials with CIC reporting safety results (no date restrictions; English language only). Clinical trials with CIC in children and adults showed a very low occurrence of oropharyngeal adverse events (including oral candidiasis, pharyngitis, and hoarseness) and minimal systemic activity. In particular, no clinically relevant effect on cortisol levels was observed, compared with placebo or active comparators, even with high-dose CIC treatment (up to 1280 microg/day) and in asthma of all severities. Furthermore, there was no clinically relevant effect of CIC treatment on growth in children with mild asthma compared with placebo. The favorable safety profile of CIC may allay patient and physician concern regarding ICS when using this agent. Guideline-recommended use of ICS medications may help optimize treatment outcomes in asthma.
authors.affiliation: Department of Medicine and Pediatrics, Penn State University, College of Medicine, Hershey, Pennsylvania 17033, USA. tcraig@psu.edu
authors.forename: Timothy
authors.initials: T
authors.lastname: Craig