Once-daily ciclesonide in children: efficacy and safety in asthma.
OBJECTIVE
To compare the efficacy and safety of once-daily inhaled ciclesonide 40 mug (CIC40), 80 mug (CIC80), and 160 mug (CIC160) with placebo in children with persistent asthma of all severities.


METHODS
Overall, 1031 children age 4 to 11 years were randomized into 2 identical double-blinded, placebo-controlled, parallel group studies consisting of a run-in phase followed by 12 weeks of treatment. Both studies were designed to allow for a prespecified integrated analysis. The primary outcome variable was change in forced expiratory volume in 1 second (FEV(1)) percent predicted between baseline and study end; treatment comparisons were assessed using analysis of covariance. Additional endpoints included asthma symptom scores, daily albuterol use, and safety, including hypothalamic-pituitary-adrenal (HPA) axis function.


RESULTS
Baseline characteristics were comparable; 59.4% of patients had moderate asthma, and 24.1% had severe asthma. All ciclesonide doses were associated with greater improvements in baseline to week 12 FEV(1) percent predicted versus placebo (CIC40, 11.97; CIC80, 13.58, P <.05; CIC160, 14.17, P < .01). Significant improvements in asthma symptoms (P < .01) and reductions in albuterol use were reported. Ciclesonide was well tolerated with no effect on HPA axis function.


CONCLUSIONS
In this integrated analysis, ciclesonide was effective and well tolerated in children with persistent asthma.
Gelfand
Erwin W
EW
Department of Pediatrics, National Jewish Medical and Research Center, Denver, CO 80206, USA. gelfande@njc.org
Georgitis
John W
JW
Noonan
Michael
M
Ruff
Michael E
ME
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000420:Albuterol / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005541:Forced Expiratory Volume; D006801:Humans; D006854:Hydrocortisone / Q000097:blood / Q000652:urine; D036501:Metered Dose Inhalers; D011282:Pregnenediones / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D001993:Bronchodilator Agents; D011282:Pregnenediones; D000420:Albuterol; C120481:ciclesonide; D006854:Hydrocortisone