Efficacy and safety of inhaled ciclesonide compared with chlorofluorocarbon beclomethasone dipropionate in adults with moderate to severe persistent asthma.
OBJECTIVE
Inhaled corticosteroids are recognized as first-line therapy in the management of asthma; however, their use may be limited by systemic and local side-effects. Ciclesonide, a novel pro-drug inhaled corticosteroid, is activated in the lungs and is expected to have less systemic and local side-effects. This study evaluated the efficacy and safety of ciclesonide in hydrofluoroalkane (HFA) compared with beclomethasone dipropionate (BDP) in a chlorofluorocarbon (CFC) formulation in adult patients with moderate to severe asthma.


METHODS
This was a multicentre, randomized, open-label, parallel-group comparative study. The patients were given 800 microg/day of CFC-BDP in the four-week baseline period. After the baseline period, 319 patients were randomly allocated into three groups which, respectively, received HFA-ciclesonide 400 microg/day (without a spacer), HFA-ciclesonide 800 microg/day (without spacer) and CFC-BDP 800 microg/day (with spacer) for the eight-week treatment period. The primary efficacy variable was morning PEF.


RESULTS
The morning PEF increased by 16.02 L/min in the 400 microg HFA-ciclesonide group, 23.98 L/min in the 800 microg HFA-ciclesonide group and 5.91 L/min in the 800 microg CFC-BDP group. Better outcomes were achieved by the use of 800 microg/day of HFA-ciclesonide compared with 800 microg/day of CFC-BDP (P = 0.001). There was no difference in adverse events between the groups.


CONCLUSIONS
In adult patients with moderate to severe asthma, 800 microg/day of HFA-ciclesonide was significantly more effective than 800 microg/day of CFC-BDP. Ciclesonide at doses of 400 microg/day and 800 microg/day was safe and 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
Sakai
Tomoki
T
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; D005260:Female; D006801:Humans; D006845:Hydrocarbons, Fluorinated; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage*; D005466:Fluorocarbons
D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D001507:Beclomethasone; D006845:Hydrocarbons, Fluorinated; D011282:Pregnenediones; C094049:apaflurane; D005466:Fluorocarbons; C120481:ciclesonide