Onset of action of ciclesonide once daily in the treatment of seasonal allergic rhinitis.
BACKGROUND
Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR).


OBJECTIVE
To evaluate the time to onset of action of ciclesonide, 200 microg/d, in patients with seasonal AR (SAR).


METHODS
In a double-blind, randomized, placebo-controlled study conducted in an environmental exposure chamber, 509 adults with at least a 2-year history of SAR completed 1 to 5 priming sessions of ragweed pollen exposure (mean [SD] of 3,500 [500] grains/m3). Patients with successful priming visits (defined as patient-assessed instantaneous total nasal symptom scores [TNSSs] > or =6 and rhinorrhea or nasal congestion scores -2) received a single dose of intranasal ciclesonide, 200 microg (n = 255), or placebo (n = 254). The difference in the change from baseline in TNSSs between the ciclesonide and placebo groups was measured hourly 1 to 12 hours after study drug administration.


RESULTS
At hour 6, the mean treatment difference in TNSSs between ciclesonide and placebo was 0.53 (95% confidence interval, 0.03-1.03; P = .02). Significant treatment differences in favor of ciclesonide were also observed at 2 additional time points: hour 10 (P = .01) and hour 12 (P = .008).


CONCLUSIONS
These results confirm that intranasal ciclesonide, 200 microg/d, has an onset of action of 6 hours in patients with SAR.
Couroux
Peter
P
Allied Research International-Cetero Research, Mississauga, Ontario, Canada. PCouroux@allied-research.com
Kunjibettu
Sudeesha
S
Hall
Nancy
N
Wingertzahn
Mark A
MA
D000281:Administration, Intranasal; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000276:immunology; D013997:Time Factors; D055815:Young Adult
D018926:Anti-Allergic Agents; D011282:Pregnenediones; C120481:ciclesonide