Rapid onset of control with budesonide Turbuhaler in patients with mild-to-moderate asthma

Background: Budesonide (Pulmicort) is an inhaled corticosteroid with high t opical potency but low systemic activity. Turbuhaler is a novel breath-actu ated, multi-dose, dry-powder inhaler. Objectives: This study was conducted to determine the efficacy and safety o f two different dose regimens of budesonide Turbuhaler, compared with place bo, in adult patients with mild-to-moderate asthma not well-controlled with bronchodilator therapy. Methods: This double-blind, randomized, placebo-controlled, parallel-group, multicenter study compared the efficacy and safety of 200 mu g and 400 mu g of budesonide, administered twice daily via Turbuhaler, with placebo, in 273 adult patients (aged 19 to 70 years) with mild-to-moderate asthma (FEV1 67% of predicted normal), nor well-controlled with bronchodilator therapy. Efficacy was assessed by pulmonary function tests and patient assessments of asthma symptom control. Safety was assessed in terms of adverse events, laboratory evaluations, and physical examinations. Results: Two hundred and 400 mu g of budesonide bid were significantly more effective than placebo at improving morning PEF (mean differences from pla cebo of 43.63 L/min and 40.10 L/min, respectively; P <.001) and FEV1 (mean differences from placebo of 0.44 L, and 0.50 L, respectively; P <.001) over the 12-week treatment period. Onset of action as assessed by morning PEF w as within two days. Basal and stimulated plasma cortisol concentrations wer e not significantly affected by budesonide treatment compared with placebo. Conclusions: Treatment of adults suffering from mild-to-moderate asthma wit h budesonide Turbuhaler is well tolerated and results in a rapid onset of a sthma control which is maintained over time.