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Respir Med. 2007 Aug;101(8):1677-86. Epub 2007 Apr 19.

A randomized study comparing ciclesonide and fluticasone propionate in patients with moderate persistent asthma.

Author information

1
Institut de cardiologie et de pneumologie de l'Université Laval, Hôpital Laval, 2725 Chemin Sainte-Foy, Québec City, Que., Canada G1V 4G5. lpboulet@med.ulaval.ca

Abstract

OBJECTIVE:

To compare the effects of once-daily ciclesonide and twice-daily fluticasone propionate in patients with moderate persistent asthma.

METHODS:

Patients aged 12-75 years with moderate bronchial asthma entered a 1-4 week run-in period. For inclusion into the 12-week, randomized, open-label treatment period, patients had to have a forced expiratory volume in 1s (FEV1) of either 60-80% of predicted or 80% of predicted and a defined use of rescue medication and asthma symptoms, depending on previous treatment. Patients received ciclesonide 320 microg once daily (ex-actuator) or fluticasone propionate 200 microg twice daily. Primary efficacy endpoint was change from baseline in FEV1.

RESULTS:

In total, 474 patients were randomized. FEV1 increased significantly from baseline with ciclesonide and fluticasone propionate in the intention-to-treat (ITT) and per-protocol (PP) analyses (all p < 0.0001). Treatment difference was -31 mL (95% confidence interval [CI]: -121, 59) in the PP analysis, demonstrating non-inferiority of ciclesonide. Similar findings were seen for other measures of lung function. In the ITT population, asthma symptom scores and rescue medication use decreased with both treatments (all p < 0.0001). Improvement in health-related quality of life (HRQoL) from baseline was significantly greater with ciclesonide than fluticasone (p = 0.005; one-sided). There were no cases of oral candidiasis in patients receiving ciclesonide and nine cases (3.8%) in those receiving fluticasone propionate (p = 0.002; one-sided).

CONCLUSIONS:

Treatment with once-daily ciclesonide and twice-daily fluticasone propionate resulted in similar improvements in lung function in patients with moderate persistent asthma. Ciclesonide showed significant improvements in oral candidiasis and HRQoL over fluticasone.

PMID:
17448650
DOI:
10.1016/j.rmed.2007.03.001
[Indexed for MEDLINE]
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