Inhaled budesonide for adults with mild-to-moderate asthma: a randomized placebo-controlled, double-blind clinical trial.

CONTEXT Budesonide is an inhaled corticosteroid with high topical potency and low systemic activity recommended in the treatment of chronic asthma. OBJECTIVE This study was conducted to determine the efficacy and safety of inhaled budesonide via a breath-activated, multi-dose, dry-powder inhaler. TYPE OF STUDY Multicenter randomized parallel-group, placebo-controlled, double-blind, clinical trial. SETTING Multicenter study in the university units. PARTICIPANTS Adult patients with mild-to-moderate asthma that was not controlled using bronchodilator therapy alone. PROCEDURES Comparison of budesonide 400 microg administered twice daily via a breath-activated, multi-dose, dry-powder inhaler with placebo, in 43 adult patients (aged 15 to 78 years) with mild-to-moderate asthma (FEV1 71% of predicted normal) that was not controlled using bronchodilator therapy alone. MAIN MEASUREMENTS Efficacy was assessed by pulmonary function tests and asthma symptom control (as perceived by the patients) and the use of rescue medication. RESULTS Budesonide 400 microg (bid) was significantly more effective than placebo in improving morning peak expiratory flow (mean difference: 67.9 l/min; P < 0.005) and FEV1 (mean difference: 0.60 l; P < 0.005) over the 8-week treatment period. Onset of action, assessed by morning peak expiratory flow, occurred within the first two weeks of treatment. CONCLUSIONS Budesonide via a breath-activated, multi-dose, dry-powder inhaler results in a rapid onset of asthma control, which is maintained over time and is well tolerated in adults with mild-to-moderate asthma.