LOW DOSE FLOVENT ONCE OR TWICE DAILY VIA THE DISKUS IMPROVES LUNG FUNCTION AND MAINTAINS ASTHMA STABILITY IN STEROID-NAIVE ASTHMATICS.
Stuart Harding, MD; Abbas Hamedani, MS; and Anne Leslie Stevens, RRT, CPFT; Glaxo Wellcome, Inc, Research Triangle Park, NC.
A 12-week, multi-center, double-blind, double-dummy, parallel-group trial compared the efficacy and safety of fluticasone propionate (FP), beclomethasone dipropionate (BDP) and placebo (PLA) in 299 male and female subjects aged 12 and up who were currently treated with bronchodilator therapy and who had not used inhaled corticosteroids (ICS) for at least one month prior to study enrollment. The DISKUS device, a breath-actuated 60-dose dry powder inhaler, was used to deliver treatments of FP 200mcg once-daily (FP-QD), FP 100mcg twice-daily (FP-BID) or placebo (PLA). A metered dose inhaler (MDI) was used to deliver BDP 168mcg BID. Subjects treated with FP-QD and FP-BID had mean changes from baseline at endpoint in FEV1 % predicted of 9.45% and 13%, respectively and BDP treated subjects had mean changes from baseline at endpoint of 12% (p£0.048 vs. PLA). PEF was measured twice daily by subjects and FP-QD and FP-BID treated subjects demonstrated mean increases from baseline at endpoint of 27 and 31 L/min in AM PEF and of 26 and 25 L/min in PM PEF, respectively (p£ 0.009 FP vs. PLA). Changes in AM and PM PEF in the BDP group were similar to those seen with FP treatment. At endpoint, mean total Ventolin use by subjects in all active treatment groups decreased significantly from baseline (p£ 0.019 vs. PLA). Subjects were dropped from the study for lack of efficacy (LOE) when meeting pre-determined asthma stability criteria including lung function and symptom measures. Fewer subjects on FP-QD (n=7) and FP-BID (n=5) were dropped for LOE compared to PLA (n=19). Ten subjects on BDP were withdrawn for LOE and this was not significantly different from PLA. Frequency of adverse experiences (AEs) was similar across all treatment groups with the most frequently reported AEs involving the ear, nose, and throat body system. Data from these subjects with asthma previously treated with bronchodilator therapy only demonstrated that FP administered once or twice daily was effective in improving pulmonary function and maintaining asthma stability. Supported by GlaxoWellcome, Inc.