A BLINDED COMPARISON OF FLUTICASONE PROPIONATE WITH BUDESONIDE VIA POWDER DEVICES IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ASTHMA - A CLINICAL-EVALUATION

yIN VITRO and in vivo data have demonstrated that there are detectable differences between inhaled corticosteroids commonly used to treat as thma. However, controversy still remains as to whether these differenc es translate into clinical benefits. This 12-week, international, rand omized, double-blind, parallel-group study was undertaken to compare t he efficacy and safety of fluticasone propionate (FP) 800 mu g daily, administered as a powder via the Diskhaler(R), and budesonide (BUD) 16 00 mu g daily, administered using the Turbuhaler(R) in adult patients with moderate-to-severe asthma. A total of 518 patients participated i n the study, 256 of whom received FP and 262 BUD. Assessment of mean m orning peak expiratory flow (PEF) over the 12-week treatment period re vealed a statistically significant difference in efficacy between FP 8 00 mu g daily and BUD 1600 mu g daily in favour of FP (p = 0.003), wit h an overall improvement of 20.9 l/min with FP compared with 12.41/min on BUD. Statistically significant differences in favour of FP were se en over the 12 weeks for mean evening PEF (P = 0.04), diurnal PEF vari ation (p = 0.03) and percentage predicted PEF (p = 0.003), as well as forced expiratory volume (p = 0.008), forced vital capacity (p = 0.02) and PEF (p = 0.005) measured at clinic visits. The median percentage of symptom-free nights increased over the 12-week study period in both treatment groups, with similar changes seen for the median percentage of days with symptom score <2, rescue medication use and exacerbation s of asthma. The incidence of adverse events was found to be comparabl e in the two treatment groups. The geometric mean ratios of serum cort isol levels were found to be 1.03 for FP, indicating no mean hypothala mic-pituitary-adrenal axis suppression from baseline, and 0.93 for BUD (p = 0.0002 compared with FP). In summary, FP 800 mu g daily showed a greater efficacy/safety ratio in the treatment of moderate-to-severe asthma than BUD 1600 mu g daily.