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The safety profile of ciclesonide in the treatment of persistent asthma

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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 g/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.

Keywords: Adverse events; asthma; ciclesonide; growth; hypothalamic‐pituitary‐adrenal axis; inhaled corticosteroid; oral candidiasis; oropharyngeal adverse events; safety; systemic adverse events

Document Type: Research Article


Affiliations: Department of Medicine and Pediatrics, Penn State University, College of Medicine, Hershey, Pennsylvania, USA.

Publication date: May 1, 2009

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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