Anti-inflammatory effects of once daily low dose inhaled ciclesonide in mild to moderate asthmatic patients.
BACKGROUND
Ciclesonide exhibits clinical efficacy at 160 microg (ex-actuator) once daily but the anti-inflammatory effects at this dose are not known. We wished to know whether 4 weeks therapy with ciclesonide pMDI 160 microg once daily in the morning exhibited significant anti-inflammatory effects.


METHODS
Seventeen patients with mild persistent asthma (FEV(1) 3.35 l) were recruited into a double-blind placebo-controlled randomized crossover study. Measurements were made after ciclesonide and placebo treatment as well as after run-in and washout periods, for adenosine monophosphate (AMP) bronchial challenge (primary variable), exhaled nitric oxide (NO) and induced sputum (in a subgroup).


RESULTS
The mean (SEM) AMP bronchial challenge PC(20) following ciclesonide (140 (63) mg/ml) was significantly (P < 0.001) increased compared with placebo (17 (8) mg/ml), run-in (13 (5) mg/ml) and washout (9 (3) mg/ml) periods. This amounted to an eightfold (CI: 5.3-12.0) for ciclesonide vs placebo. Likewise, there were significant improvements in exhaled NO levels and a significant reduction in induced sputum eosinophil cell counts.


CONCLUSIONS
We have shown that inhaled ciclesonide given at 160 microg once daily in the morning exhibits significant anti-inflammatory effects that are in keeping with the previously described clinical effects.
Wilson
A M
AM
Biomedicine Group, School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, UK.
Duong
M
M
Pratt
B
B
Dolovich
M
M
O'Byrne
P M
PM
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000494:pharmacology*; D001249:Asthma / Q000188:drug therapy*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage / Q000494:pharmacology*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D011282:Pregnenediones; C120481:ciclesonide