Comparison of the efficacy and safety of mometasone furoate dry powder inhaler to budesonide Turbuhaler®

Mometasone furoate (MF) administered by dry powder inhaler (DPI) was composed with budesonide (BUD) Turbuhaler(R) in the treatment of moderate persistent asthma. The patients were randomized to one of four treatment groups: MF DPI (100, 200, 400 mug b.i.d) or BUD Turbuhaler(R). 400 mug b.i.d in a 12-week, active-controlled, evaluator-blind, multicentre international trial. The primary efficacy variable was the mean change from baseline to endpoint Oast treatment visit) in forced expiratory volume in one second (FEV1), Changes in FEV1 showed a statistically significant superiority (p<0.05) of MF DPI 200 and 400 <mu>g b.i.d compared with the BUD Turbuhaler(R) 400 mug b.i.d treatment. Significant superiority (p<0.05) was also seen in scores for several secondary efficacy variables when MF DPI was compared,vith BUD Turbuhaler(R) treatment. MF DPI 200 <mu>g b.i.d was comparable to MF DPI 400 mug b.i.d in therapeutic benefit. The incidence of oral candidiasis was no more than 3% in any group. All treatments were well tolerated. A total daily dose of 400 mug of mometasone furoate administered by dry powder inhaler provides a well-tolerated treatment for patients with moderate persistent asthma and results in a significantly greater improvement, when compared to a daily dose of 800 mug BUD Turbuhaler(R) in the parameters measured in this study.