Efficacy and safety of dry powder fluticasone propionate in children with persistent asthma

Background Flovent Diskus is a powder formulation of the inhaled corticosteroid fluticasone propionate (FP) delivered via a breath-actuated, multidose inhaler. Objective To determine the efficacy and safety of dry powder FP administered once or twice daily (200 μg per day) to children with persistent asthma. Methods Twelve-week, randomized, double-blind, placebo-controlled, multicenter trial with a 52-week, open-label extension. Children aged 4 to 11 were required to have pulmonary function 50% to 85% of predicted values. The population was stratified for baseline therapy (inhaled corticosteroid/cromolyn or bronchodilators only). After a 2-week placebo run-in, 242 patients received dry powder FP 200 μg each morning, dry powder FP 100 μg BID, or placebo for 12 weeks; 192 were rerandomized to the QD or BID regimen for an additional 52 weeks of open-label treatment. Primary endpoints were mean changes in FEV 1 and morning PEF recorded at clinic visits. Results Both dry powder FP regimens significantly improved FEV 1 , evening PEF, and asthma symptoms at the double-blind phase endpoint ( P ≤ .017 compared with placebo). The BID regimen also significantly improved morning PEF and nighttime awakenings due to asthma ( P ≤ .005). Among patients previously treated with inhaled corticosteroids/cromolyn, improvements observed with the QD and BID regimens were similar. Patients switched from BID to open-label QD treatment showed additional improvements at week 52 generally comparable to patients who received the BID regimen during both phases. Fluticasone propionate was well tolerated for up to 64 weeks with few reports of drug-related adverse events or morning plasma cortisol abnormalities. Conclusions Once daily dosing of dry powder FP 200 μg is an effective and convenient alternative for children whose asthma is controlled with a more frequent dosing regimen of inhaled corticosteroids.