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

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Hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) extra-fine aerosol and HFA-fluticasone propionate (HFA-FP) are chlorofluorocarbon-free inhalers.We conducted an 8-week, open study to demonstrate the equivalence of HFA-BDP (800 μ g day−1) and HFA-FP (1000 μ g day−1) in moderate to severe asthma. Symptomatic patients on 500–1000 μ g day−1CFC-BDP (or equivalent) and short-acting β -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, with increases in peak expiratory flow in the morning (AM PEF) and asthma symptoms (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 difference between treatments within ±25 l min−1) in the two groups: 29·59 (5·19) 1 min−1for HFA-BDP vs. 17·3 (5·45) 1 min−1for HFA-FP (90% CI−0·02, 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−1P<0·01; 90% CI; 2·66, 31·10]. At week 8 in the ITT population, there were no statistically significant differences in FEV1, β -agonist use, asthma symptom/sleep disturbance scores, or percentage of days without asthma symptoms/sleep disturbance. There was a significantly greater 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 value at week 8 (P<0·01). Both treatments were well tolerated and there were 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 μ g−1was at least as effective and equally well tolerated as 1000 μ g day−1HFA-FP.