Once-daily ciclesonide via metered-dose inhaler: Similar efficacy and safety with or without a spacer.
BACKGROUND
Inhaled corticosteroids (ICS) are recommended as first-line treatment for adults and children with persistent asthma. The Global Initiative for Asthma recommends that patients taking medium- or high-dose ICS delivered by metered-dose inhalers (MDIs) should use a spacer device.


METHODS
This randomized, open-label, 12-week, non-inferiority study compared the efficacy and safety of ciclesonide 160microg once daily delivered via hydrofluoroalkane-MDI alone (CIC160) or with a spacer (either an AeroChamber Plus [CIC160P] or an AeroChamber MAX [CIC160M]) in patients with persistent asthma. The primary efficacy variable was change in forced expiratory volume in 1s (FEV(1)) from baseline to study end.


RESULTS
Significant improvements in FEV(1) were observed from baseline to study end in each treatment group; least squares mean change from baseline ranged between 0.32 and 0.34L in the per-protocol (PP) analysis and similar results were observed for the intention-to-treat (ITT) analysis (p<0.0001 for all). Non-inferiority of CIC160P and CIC160M to CIC160 was observed for both PP and ITT populations (p<0.0001 [one-sided]). In all groups, daily asthma symptom scores were reduced to 0 and significant reductions were observed in rescue medication use at study end (p<0.0001 versus baseline for all). Ciclesonide was well tolerated in all groups and no cases of oral candidiasis were reported. Morning serum cortisol levels significantly increased in all groups from baseline to study end (p< or =0.0389), with no significant between-treatment differences.


CONCLUSIONS
In patients with persistent asthma, ciclesonide was shown to have similar efficacy and tolerability when administered via MDI alone or with a spacer.
Engelstätter
Renate
R
Nycomed GmbH, Konstanz, Germany. renate.engelstaetter@nycomed.com
Szlávik
M
M
Gerber
Claudia
C
Beck
Ekkehard
E
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
D018926:Anti-Allergic Agents; D011282:Pregnenediones; C120481:ciclesonide