Efficacy and safety of once-daily inhaled ciclesonide in adults with mild to moderate asthma: a double-blind, placebo-controlled study.
OBJECTIVE
Inhaled corticosteroids are recommended as first-line therapy for the management of asthma, although side-effects may limit their use. Ciclesonide, a novel pro-drug inhaled corticosteroid, exerts potent and prolonged local anti-inflammatory effects in the lungs, and is considered to have an improved safety and tolerability profile. The aim of this study was to evaluate the efficacy and safety of ciclesonide in adult patients with mild to moderate asthma.


METHODS
A placebo-controlled, multicentre, randomized, double-blind, parallel-group study was conducted. During the 4-week baseline period, patients were given 400 microg/day of beclomethasone dipropionate in a chlorofluorocarbon formulation. After the baseline period, 311 patients were given once-daily 100, 200 or 400 microg of ciclesonide or placebo for an 8-week treatment period without the use of a spacer. The primary efficacy variable was morning PEF.


RESULTS
Changes in the morning PEF (least squares mean) at the end of the study were 4.23 L/min (P < 0.001) in the 100 microg group, 3.75 L/min (P < 0.001) in the 200 microg group, -0.40 L/min (P < 0.001) in the 400 microg group, as compared with -24.95 L/min in the placebo group. In the ciclesonide groups, the PEF remained at the same level as the baseline period. No large differences were observed between the placebo group and the ciclesonide groups regarding safety.


CONCLUSIONS
Once-daily administration of ciclesonide at doses of 100, 200 or 400 microg was shown to be effective in adult patients with mild to moderate asthma. Ciclesonide is considered to have favourable safety profiles and be well tolerated.
Adachi
Mitsuru
M
First Department of Internal Medicine, Showa University, School of Medicine, Tokyo, Japan. adachim@med.showa-u.ac.jp
Ishihara
Kyosuke
K
Inoue
Hiroshi
H
Kudo
Koichiro
K
Takahashi
Kiyoshi
K
Morita
Yutaka
Y
Masuda
Ken-Ichi
K
Takada
Yoshinori
Y
Kato
Ryuichi
R
Miyamoto
Terumasa
T
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D011282:Pregnenediones / Q000008:administration & dosage*; D013147:Spirometry; D014797:Vital Capacity
D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D011282:Pregnenediones; D001507:Beclomethasone; C120481:ciclesonide