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.