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Published on: April 6, 2017

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

Erwin W Gelfand1, John W Georgitis, Michael Noonan

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

The Journal of Pediatrics
|April 18, 2006
PubMed

Insights

Inhaled ciclesonide effectively improved lung function and asthma symptoms in children with persistent asthma. The medication was well-tolerated and did not impact the hypothalamic-pituitary-adrenal axis function.

Area of Science:

  • Pediatric Pulmonology
  • Respiratory Medicine
  • Pharmacology

Background:

  • Persistent asthma affects children globally, necessitating effective and safe treatment options.
  • Inhaled corticosteroids are a cornerstone of asthma management, but their efficacy and safety profiles in pediatric populations require continuous evaluation.

Purpose of the Study:

  • To evaluate the efficacy and safety of once-daily inhaled ciclesonide at doses of 40, 80, and 160 mug compared to placebo in children with persistent asthma.
  • To assess the impact of ciclesonide on lung function, asthma symptoms, albuterol use, and hypothalamic-pituitary-adrenal (HPA) axis function.

Main Methods:

  • An integrated analysis of two identical double-blinded, placebo-controlled, parallel-group studies involving 1031 children aged 4 to 11 years.
  • Participants received 12 weeks of treatment with either inhaled ciclesonide (40, 80, or 160 mug) or placebo.
  • Primary endpoint was the change in forced expiratory volume in 1 second (FEV(1)) percent predicted from baseline to week 12; secondary endpoints included symptom scores, albuterol use, and HPA axis function.

Main Results:

  • All ciclesonide doses demonstrated statistically significant improvements in FEV(1) percent predicted compared to placebo.
  • Patients treated with ciclesonide experienced significant reductions in asthma symptom scores and albuterol use.
  • Ciclesonide was well-tolerated, with no observed adverse effects on HPA axis function across all tested doses.

Conclusions:

  • Once-daily inhaled ciclesonide is an effective treatment for children with persistent asthma of all severities.
  • Ciclesonide offers a favorable safety profile in pediatric patients, including preservation of HPA axis function.
  • These findings support the use of inhaled ciclesonide as a therapeutic option for managing pediatric persistent asthma.
Abstract

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