Evaluation of efficacy and safety of budesonide delivered via two dry powder inhalers

Abstract

The efficacy and safety of budesonide DPI-A and DPI-B versus placebo were demonstrated across the low to medium inhaled corticosteroid dose range in children >or= 6 years with very mild asthma and adolescents and adults with mild-to-moderate asthma. The study is limited by the evaluation of only two doses for each product in both studies. Additionally, the studies were not designed to test equivalence or noninferiority between the active products. Pharmacokinetic characterization was limited because of the small sample sizes.