Abstract
BackgroundCiclesonide is a new inhaled corticosteroids licensed for the prophylactic treatment of persistent asthma in adults. Currently beclomethasone dipropionate, budesonide and fluticasone propionate are the most commonly prescribed inhaled corticosteroids for the treatment of asthma but there has been no systematic review comparing the effectiveness and safety ciclesonide to these agents. We therefore aimed to systematically review published randomised controlled trials of the effectiveness and safety of ciclesonide compared to alternative inhaled corticosteroids in people with asthma.MethodsWe performed literature searches on MEDLINE, EMBASE, PUBMED, the COCHRANE LIBRARY and various Internet evidence sources for randomised controlled trials or systematic reviews comparing ciclesonide to beclomethasone or budesonide or fluticasone in adult humans with persistent asthma. Data was extracted by one reviewer.ResultsFive studies met the inclusion criteria. Methodological quality was variable. There were no trials comparing ciclesonide to beclomethasone. There was no significant difference between ciclesonide and budesonide or fluticasone on the following outcomes: lung function, symptoms, quality of life, airway responsiveness to a provoking agent or inflammatory markers. However, the trials were very small in size, increasing the possibility of a type II error. One trial demonstrated that the combined deposition of ciclesonide (and its active metabolite) in the oropharynx was 47% of that of budesonide while another trial demonstrated that the combined deposition of ciclesonide (and its active metabolite) in the oropharynx was 53% of that of fluticasone. One trial demonstrated less suppression of cortisol in overnight urine collection after ciclesonide compared to fluticasone (geometric mean fold difference = 1.5, P < 0.05) but no significant difference in plasma cortisol response.ConclusionThere is very little evidence comparing CIC to other ICS, restricted to very small, phase II studies of low power. These demonstrate CIC has similar effectiveness and efficacy to FP and BUD (though equivalence is not certain) and findings regarding oral deposition and HPA suppression are inconclusive. There is no direct comparative evidence that CIC causes fewer side effects since none of the studies reported patient-based outcomes.
Highlights
Ciclesonide is a new inhaled corticosteroids licensed for the prophylactic treatment of persistent asthma in adults
The Kanniess et al study[19] was the only RCT not apparently sponsored by a pharmaceutical company manufacturing CIC
The authors state that data were logarithmically transformed to normalize the distribution but give no comment on how the data were skewed
Summary
Ciclesonide is a new inhaled corticosteroids licensed for the prophylactic treatment of persistent asthma in adults. We aimed to systematically review published randomised controlled trials of the effectiveness and safety of ciclesonide compared to alternative inhaled corticosteroids in people with asthma. Inhaled corticosteroids (ICS) have a central role in the treatment of asthma They are the most effective prophylactic agents available, in patients with mild to moderate asthma and persistent symptoms[1] and are recommended for most adult patients with chronic asthma whose symptoms are not controlled by inhaled short acting β 2 agonists [2,3,4]. Given that ciclesonide is being actively marketed as an alternative to alternative to other inhaled corticosteroids, our objective in this study was to systematically review published randomised controlled trials of the effectiveness and safety of ciclesonide compared to alternative inhaled corticosteroids in people with asthma
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