A 24-week comparison of low-dose ciclesonide and fluticasone propionate in mild to moderate asthma.
ABSTRACT To compare the efficacy of ciclesonide (80 microg/day) with fluticasone propionate (200 microg/day) in mild to moderate persistent asthma.
Patients aged 12-75 years and previously treated with low doses of inhaled corticosteroid (fluticasone propionate 250 microg/day or equivalent) entered a 2-4 week run-in period during which only rescue medication was permitted. For inclusion into the double-blind, 24-week treatment period, patients had to show a forced expiratory volume in 1s (FEV(1)) of 61-90% predicted and a decrease in FEV(1) during run-in of >or=10%. Patients (n = 480) were randomized to ciclesonide 80 microg (ex-actuator) once daily in the evening or fluticasone propionate 100 microg (ex-valve) twice daily. The primary efficacy variable was the change from baseline in FEV(1). Secondary efficacy variables included asthma control and asthma-specific quality of life.
Both treatments significantly increased FEV(1) and other lung function variables from baseline (p < 0.0001, both groups, all variables). The least squares mean increases in FEV(1) were 0.46L (ciclesonide) and 0.52L (fluticasone propionate); non-inferiority of ciclesonide to fluticasone propionate was demonstrated (p = 0.0002, per-protocol analysis). Five patients in each group experienced asthma exacerbations. Improvements in the percent of days with asthma control (days with no asthma symptoms and no use of rescue medication) and asthma-specific quality of life were comparable between treatments.
The study confirmed similar efficacy of ciclesonide 80 microg once daily and fluticasone propionate 100 microg twice daily in mild to moderate persistent asthma. The low dose of ciclesonide was efficacious during long-term treatment. EudraCT number: 2004-001072-39.
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ABSTRACT: Growth impairment in children with asthma, as a consequence of inhaled corticosteroids (ICS), is a major issue. Adverse systemic effects of ICS have been reviewed extensively, but no clinically relevant effects are reported if they are used in an appropriate dose as advocated in most guidelines. Growth studies can be divided into knemometry studies, intermediate term studies, and long term studies up to final adult height. These different studies provide different information. Knemometry demonstrates a dose dependent systemic effect, while all intermediate term studies demonstrate growth reduction of approximately one cm after one year of treatment. Most reassuring is that this delay seems to be temporary. The one study with a follow-up to final height shows no differences between the ICS and non-ICS treated children. The studies suggest that the use of ICS with respect to growth is safe if these drugs are used in a low to medium dose.Paediatric Respiratory Reviews 06/2013; 14(2):107-111. · 2.77 Impact Factor
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ABSTRACT: Asthma severity is classified according to the level of treatment required to control symptoms. Inhaled corticosteroids are the recommended first-line therapy for the treatment of persistent asthma, and when asthma remains uncontrolled, one option is to increase the inhaled corticosteroids dose. However, there is a concomitant risk of increasing local and systemic adverse events, which may impact patient adherence and physician prescribing practices. Ciclesonide is delivered as a prodrug, has high peripheral lung deposition and high protein-binding capabilities, and is rapidly eliminated from the systemic circulation. This article reviews the use of high-dose ciclesonide in patients with severe asthma and considers whether the pharmacology of ciclesonide translates into it being an efficacious and well-tolerated option for patients requiring a step-up in their asthma treatment.Expert Review of Respiratory Medicine 08/2013; 7(4):339-48.