Efficacy of HFA-beclomethasone dipropionate extra-fine aerosol (800 mu g day(-1)) versus HFA-fluticasone propionate (1000 mu g day(-1)) in patients with asthma

Hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) extra-fine aer osol and HFA-fluticasone propionate (HFA-FP) are chlorofluorocarbon-free in halers. We conducted an 8-week, open study to demonstrate the equivalence of HFA-BD P (800 mug day(-1)) and HFA-FP (1000 mug day(-1)) in moderate to severe ast hma. Symptomatic patients on 500-1000 mug day(-1) CFC-BDP (or equivalent) a nd short-acting beta -agonist, were randomized to HFA-BDP (n = 101) or HFA- FP (n = 97) after 7-14 (+/-2) day run-in. In the intent-to-treat (ITT) population (n = 198), both treatments provided clinically and statistically significant improvements in asthma control, w ith increases in peak expiratory flow in the morning (AM PEF) and asthma sy mptoms (within treatment analysis P<0.05). Mean (SE) change in AM PEF from baseline at week 8 was equivalent (defined as 90% CI for the mean differenc e between treatments within +/- 25 1 min(-1)) in the two groups: 29.59 (5.1 9) 1 min(-1) for HFA-BDP vs. 17.3 (5.45) 1 min(-1) for HFA-FP (90% CI-002, 24.91). For the per-protocol population (n = 121), the mean (SE) change in AM PEF from baseline was not equivalent; AM PEF improved to a significantly greater extent in the HFA-BDP group than HFA-FP group [34.84 (7.08) vs. 20 .63 (7.32) 1 min(-1) P < 0.01; 90% CI: 2.66, 31.10]. At week 8 in the ITT p opulation. there were no statistically significant differences in FEV1, bet a -agonist use, asthma symptom/sleep disturbance scores, or percentage of d ays without asthma symptoms/sleep disturbance. There was a significantly gr eater reduction from baseline in mean eosinophil count for HFA-BDP compared with HFA-FP at weeks 3 and 8 (P < 0.01), and eosinophil cationic protein v alue at week 8 (P < 0.01). Both treatments were well tolerated and there we re no statistically significant differences in urinary cortisol creatinine parameters. In conclusion, this study showed that, in patients with moderate-to-severe symptomatic asthma, HFA-BDP extra-fine aerosol 800 mug(-1) was at least as effective and equally well tolerated as 1000 mug day(-1) HFA-FP.