Pharmaceutical News and Articles

Inhaled Steroids More Effective in Children

January 17, 2006

For controlling asthma in children, inhaled corticosteroids performed better than an oral leukotriene-receptor antagonist, according to a recent study.

Participants in the study who used the inhaled corticosteroid experienced more symptom-free days and had better pulmonary responses and a higher level of improvement in inflammatory biomarker profiles, compared with those who took the oral leukotriene-receptor antagonist, according to researchers Robert S Zeiger, MD, PhD, of the University of California at San Diego and colleagues.

The study was published in the January issue of the Journal of Allergy & Clinical Immunology and reported by MedPage Today on January 11, 2006.

Study Parameters & Outcomes

Researchers compared the effects of inhaled corticosteroid Flovent (fluticasone) with those of the oral leukotriene receptor antagonist Singulair (montelukast). Both drugs are indicated to control asthma in children aged 6-17 years who have persistent, mild-to-moderate asthma.

"These findings and those previously reported regarding mean group comparisons of responses to an inhaled corticosteroid and a leukotriene receptor antagonist provide pediatric-based evidence to support the present national and international recommendations for inhaled corticosteroids as the preferred first-line controller therapy for mild-to-moderate persistent childhood asthma," Dr Zeiger and colleagues wrote.

Dr Zeiger and colleagues' study grew out of the National Heart, Lung, and Blood Institute Childhood Asthma Research and Education Network (CARE) trial that measured children's forced expiratory volume at one second (FEV1) responses to fluticasone and montelukast, according to MedPage Today.

This trial was a 16-week, multicenter, double-blinded trial that compared Flovent (100 mcg twice daily) and Singular (5-10 mg nightly), according to age. A total of 144 children participated, and all were aged 6-17 and had mild-to-moderate persistent asthma and used only as-needed bronchodilators (e.g., albuterol).

Primary study outcomes were clinical, pulmonary and inflammatory responses to the controllers. Results showed that both drugs produced improvements in most clinical asthma-control measures, but Flovent performed significantly better than Singulair in most categories:

  • asthma control days
  • validated Asthma Control Questionnaire scores
  • rescue inhaler use
  • pulmonary responses (FEV1/forced vital capacity, peak expiratory flow variability, morning peak expiratory flow, and measures of impedance)
  • inflammatory biomarkers (including exhaled NO).

For example, 29.3% of participants taking Flovent had one or more additional asthma control days per week, compared with those taking Singulair (12.2% of participants).

"The more favorable clinical, pulmonary, and inflammatory responses to an inhaled corticosteroid than to a leukotriene receptor antagonist provide pediatric-based group evidence to support inhaled corticosteroids as the preferred first-line therapy for mild-to-moderate persistent asthma in children," the authors wrote.

Sources:
Inhaled Steroid Controls Asthma Better Than Oral Agent, MedPage Today, January 11, 2006.
Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma. Zeiger RS et al, Journal of Allergy & Clinical Immunology, volume 117, pages 45-52, January 2006.

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