Efficacy and safety of ciclesonide, 200 microg once daily, for the treatment of perennial allergic rhinitis.
BACKGROUND
Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR).


OBJECTIVE
To evaluate the efficacy, safety, and quality-of-life benefits of intranasal ciclesonide, 200 microg once daily, for the treatment of perennial AR (PAR).


METHODS
In this multicenter, randomized, double-blind, placebo-controlled study, adults and adolescents with at least a 2-year history of PAR received intranasal ciclesonide, 200 microg, or placebo once daily for 6 weeks. Patient-evaluated total nasal symptom scores (TNSSs), physician-assessed overall nasal signs and symptoms severity scores, and Rhinoconjunctivitis Quality of Life Questionnaire scores were evaluated.


RESULTS
Patient baseline characteristics were similar in the ciclesonide (n = 238) and placebo (n = 233) groups and were consistent with moderate PAR severity. Ciclesonide therapy significantly reduced average morning and evening reflective TNSSs compared with placebo (P < .001) and significantly reduced average morning and evening instantaneous TNSSs (P = .001) over 6 weeks of treatment. At the end point, a greater decrease from baseline was observed in physician-assessed overall nasal signs and symptoms severity for the ciclesonide group compared with the placebo group (P = .051). An appreciable improvement in combined Rhinoconjunctivitis Quality of Life Questionnaire scores at the end point was also observed in the ciclesonide group (P = .01 vs placebo). The frequency of adverse events was similar between treatment groups.


CONCLUSIONS
In this study, intranasal ciclesonide treatment was associated with significant reductions in nasal symptoms and appreciable improvements in health-related quality of life in adult and adolescent patients with PAR. Ciclesonide was well tolerated, with a safety profile comparable with that of placebo.
Meltzer
Eli O
EO
Allergy and Asthma Medical Group and Research Center, San Diego, California 92123-2661, USA. eomeltzer@aol.com
Kunjibettu
Sudeesha
S
Hall
Nancy
N
Wingertzahn
Mark A
MA
Murcia
Crystal
C
Berger
William
W
LaForce
Craig
C
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D011282:Pregnenediones; C120481:ciclesonide