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

Abstract

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.

• Authors: Erwin W Gelfand, John W Georgitis, Michael Noonan, Michael E Ruff
• Journal: The Journal of pediatrics (J Pediatr) Vol. 148 Issue 3 Pg. 377-83 (Mar 2006) ISSN: 0022-3476 [Print] United States
• PMID: 16615971 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• 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, urine)
• Metered Dose Inhalers
• Pregnenediones (therapeutic use)
• Quality of Life
• Severity of Illness Index
• Treatment Outcome