Once-daily ciclesonide in children: efficacy and safety in asthma

J Pediatr. 2006 Mar;148(3):377-83. doi: 10.1016/j.jpeds.2005.10.028.


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.

Study design: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use*
  • Albuterol / therapeutic use
  • Asthma / drug therapy*
  • Bronchodilator Agents / therapeutic use
  • Child
  • Child, Preschool
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Forced Expiratory Volume
  • Humans
  • Hydrocortisone / blood
  • Hydrocortisone / urine
  • Metered Dose Inhalers
  • Pregnenediones / therapeutic use*
  • Quality of Life
  • Severity of Illness Index
  • Treatment Outcome


  • Adrenal Cortex Hormones
  • Bronchodilator Agents
  • Pregnenediones
  • Albuterol
  • ciclesonide
  • Hydrocortisone