Montelukast added to inhaled beclomethasone in treatment of asthma

The primary objective of this study was to determine whether montelukast, a n oral leukotriene receptor antagonist, provides additional clinical benefi t to the effect of inhaled corticosteroids. A total of 642 patients with ch ronic asthma (FEV1 50 to 85% of predicted value and at least a predefined l evel of asthma symptoms) incompletely controlled with inhaled beclomethason e, 200 mu g twice daily using a spacer device, during the 4-wk run-in perio d were randomly allocated, in a double-blind, double-dummy manner to one of four treatment groups: (1) montelukast 10 mg plus continuing inhaled beclo methasone; (2) placebo tablet plus continuing inhaled beclomethasone; (3) m ontelukast 10 mg and inhaled placebo (after blind beclomethasone removal); and (4) placebo tablet and inhaled placebo (after blind beclomethasone remo val). The primary endpoints were FEV1 and daytime asthma symptoms score. Mo ntelukast provided significant (p < 0.05) clinical benefit in addition to i nhaled beclomethasone by improving FEV1, daytime asthma symptom scores, and nocturnal awakenings. Blind removal of beclomethasone in the presence of p lacebo tablets caused worsening of asthma control, demonstrating that patie nts received clinical benefit from inhaled corticosteroids. Blind removal o f beclomethasone in the presence of montelukast resulted in less asthma con trol but not to the lever of the placebo group. All treatments were well to lerated; clinical and laboratory adverse experiences were generally similar to placebo treatment in this study. in conclusion, montelukast provided ad ditional asthma control to patients benefitting from, but incompletely cont rolled on, inhaled beclomethasone.