Efficacy and safety of ciclesonide in patients with severe asthma: a 12-week, double-blind, randomized, parallel-group study with long-term (1-year) follow-up.
OBJECTIVE
To investigate the efficacy and safety of ciclesonide in patients with severe asthma over a 1-year period.


METHODS
Patients aged 18 - 75 years with persistent asthma were enrolled in a 12-week, double-blind, randomized study and treated with ciclesonide 320 or 640 μg twice daily (b.i.d.) with the option of continuing in a 40-week extension phase (EP).


METHODS
Change in morning peak expiratory flow (PEF) from baseline to 12 weeks and safety over 1 year.


RESULTS
365 patients were randomized and 275 continued into the EP. During 12 weeks' treatment, morning peak expiratory flow significantly increased by 16 l/min (p < 0.001) and 14 l/min (p = 0.001) in the 320 and 640 μg b.i.d. groups, respectively. Both doses significantly reduced total asthma symptom scores by 0.29 (p < 0.0001). In both groups, the incidence of adverse effects (AEs) was low and mean cortisol levels in serum and urine were not suppressed during the EP.


CONCLUSIONS
Ciclesonide 320 μg b.i.d. sustained lung function and asthma symptoms in patients with severe asthma over 12 weeks' treatment, and maintained lung function during a 40-week EP; ciclesonide 640 μg b.i.d. did not provide additional benefits. Long-term use of ciclesonide was not associated with increased local AEs or negative effects on cortisol levels.
King's College London, School of Medicine, The London Chest Clinic, London, UK. brian.oconnor@londonchestclinic.com
Brian J
BJ
O'Connor
Stephen
S
Kilfeather
David
D
Cheung
Henri
H
Kafé
Mark D
MD
Blagden
Noël
N
Schlösser
Jon G
JG
Ayres
Hans-Jochen
HJ
Weber
Renate
R
Engelstätter
D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006854:Hydrocortisone / Q000097:blood / Q000652:urine; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D018927:Anti-Asthmatic Agents; D011282:Pregnenediones; C120481:ciclesonide; D006854:Hydrocortisone