BUDESONIDE DELIVERED BY TURBUHALER IS EFFECTIVE IN A DOSE-DEPENDENT FASHION WHEN USED IN THE TREATMENT OF ADULT PATIENTS WITH CHRONIC ASTHMA

Background: Airway inflammation is a hallmark of asthma, therefore cur rent treatment recommendations include the use of inhaled glucocortico steroids (GCS). However, there is little evidence that the effects of inhaled GCS are dose dependent. Objectives: The objective of this stud y was to assess the efficacy and safety of a second-generation GCS, bu desonide, delivered by Turbuhaler, in adults with chronic asthma. Meth ods: In a 12-week, randomized, double-blind, multi-center, parallel-gr oup study, 473 subjects 18 to 70 years of age received either placebo or budesonide (200, 400, 800, or 1600 mu g total daily dose) administe red twice daily. Primary efficacy end points were mean change from bas eline for FEV1 and morning peak expiratory flow. Safety was assessed b y reported adverse events and by a cosyntropin-stimulation test. Resul ts: The mean baseline FEV1 was 63% to 66% of predicted normal value be tween groups. All doses of budesonide were more effective than placebo (p < 0.001). The mean changes in morning peak expiratory flow were 12 , 22, 27, and 30 L/min in the 200, 400, 800, and 1600 mu g budesonide total daily dose groups, respectively, and -27 L/min for the placebo g roup. A statistically significant dose-response effect for the mean ch ange from baseline over the 12-week study was seen for both morning pe ak expiratory flow and FEV1. Budesonide-treated subjects also demonstr ated significant reduction in asthma symptoms and bronchodilator use c ompared with placebo. There were no clinically significant differences in treatment-related adverse experiences among groups. Conclusions: B udesonide administered by Turbuhaler exhibited a dose response and was effective at low doses. It was well tolerated and significantly more effective than placebo.