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J Pediatr. 2006 Mar;148(3):377-83.

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

Author information

1
Department of Pediatrics, National Jewish Medical and Research Center, Denver, CO 80206, USA. gelfande@njc.org

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.

PMID:
16615971
DOI:
10.1016/j.jpeds.2005.10.028
[Indexed for MEDLINE]
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