Inhaled fluticasone propionate delivered by means of two different multidose powder inhalers is effective and safe in a large pediatric population with persistent asthma

Background: Inhaled corticosteroids are increasingly being used to treat mild-to-moderate asthma in children. However, data regarding therapy with this class of compounds, especially in children under age 6 years, is limited. Fluticasone propionate is a third generation inhaled corticosteroid with an optimal therapeutic index, Few large prospective clinical trials have been conducted to evaluate the efficacy and safety of fluticasone propionate powder in children. Objective: We sought to determine the efficacy and safety of fluticasone propionate powder administered by means of the Diskus and Diskhaler multidose powder inhalers in pediatric patients with persistent asthma, Methods: Fluticasone propionate powder (50 mu g or 100 mu g twice daily) or placebo was administered by means of the Diskus or Diskhaler inhalers to 437 children (4 to 11 years old) with persistent asthma for 12 weeks in a randomized, double-blind, parallel-group, multi-center trial. Patients were stratified according to whether they were receiving prior treatment with inhaled corticosteroids or cromolyn or beta(2)-agonists alone. Results: Fluticasone propionate powder administered by means of Diskus or Diskhaler significantly improved FEV1 (mean increase from baseline of 0.22 to 0.24 L: p less than or equal to 0.023), ic morning peak expiratory flow (mean increase from baseline of 48 to 55 L/min; p less than or equal to 0.006), patient-measured morning (p less than or equal to 0.001) and evening (p less than or equal to 0.003) peak expiratory flow; and asthma symptom scores (in all but the 50 mu g Diskus group; p less than or equal to 0.036), as well as reduced albuterol use (p less than or equal to 0.002) and nighttime awakenings (p less than or equal to 0.019) at endpoint, Efficacy parameters were not significantly different between the two doses with either device. More placebo-treated patients discontinued the study because of lack of efficacy than patients in any fluticasone propionate group (p < 0.001). Fluticasone propionate did not suppress morning plasma cortisol concentrations and did not affect 24-hour urinary free-cortisol excretion. Adverse events were primarily pharmacologic effects of inhaled corticosteroids, and those related to the study drug occurred with low frequency. Patient satisfaction with both the Diskus and Diskhaler devices was high, with a majority of patients (> 80%) rating them favorably. Conclusion: This study demonstrated that fluticasone propionate powder, at the conventional recommended doses of up to 200 mu g/day administered by means of Diskus or Diskhaler, was well tolerated and improved lung function in children even as young as 4 and 5 years old regardless of whether they were previously treated with inhaled corticosteroids or cromolyn or beta(2)-agonists alone.