Comparison of once- and twice-daily dosing of fluticasone propionate 200 micrograms per day administered by Diskus device in patients with asthma treated with or without inhaled corticosteroids

Background: There are limited published data regarding the efficacy of once - versus twice-daily administration of fluticasone propionate. Objective: Our purpose was to evaluate the effectiveness of fluticasone pro pionate powder 200 mu g/d administered as a once- or twice-daily dosage reg imen in patients who were currently being treated with bronchodilators only (BD patients) and in patients who required inhaled corticosteroids for mai ntenance treatment of asthma (ICS patients). Methods: Five hundred seventy patients were randomly assigned to receive on e of the following inhaled treatments through the Diskus device (Glaxo Well come, Research Triangle Park, NC) for 12 weeks: fluticasone propionate 100 mu g twice daily (FP100BID) or 200 mu g once daily (FP200QD) or placebo. Results: ED patients treated with FP100BID, FP200QD, and placebo had mean i ncreases in FEV1 from baseline to end point of 0.49 L, 0.37 L, and 0.21 L, respectively (P < .001, FP100BID vs placebo; P = .05, FP200QD vs placebo). ICS patients treated with FP100BID and FP200QD had mean increases in FEV1 o f 0.27 L and 0.11 L, respectively, compared with a decrease in FEV1 of -0.0 8 L with placebo (P < .001, PP100BID vs placebo; P = .023, FP200QD vs place bo). ED patients treated with FP100BID and FP200QD had mean increases in mo rning peak expiratory flow from baseline to end point of 31 L/min and 27 L/ min, respectively, compared with a 1 L/min increase in patients treated wit h placebo. ICS patients treated with FP100BID had a mean increase in mornin g peak expiratory flow (from baseline to end point) of IS L/min compared wi th mean decreases of -3 L/min and -12 L/min in the FP200QD and placebo grou ps, respectively. More patients were withdrawn from placebo (26% and 48%, i n ED and ICS patients, respectively) than from fluticasone propionate (7%-9 % [BID-QD] and 18%-32% [BID-QD], in ED and ICS patients, respectively) beca use of failure to meet predetermined asthma stability criteria. Conclusion: The efficacies of FP100BID and FP200QD were comparable with reg ard to improvement in pulmonary function and asthma stability in ED patient s. In ICS patients, asthma control was maintained with FP200QD, whereas FP1 00BID provided greater improvements in pulmonary function and asthma stabil ity.