Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease

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Abstract
The efficacy and safety of budesonide/formoterol in a single inhaler compared with placebo, budesonide and formoterol were evaluated in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).In a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adults (mean age 64 yrs, mean forced expiratory volume in one second (FEV1) 36% predicted normal), patients received two inhalations twice daily of either budesonide/formoterol (Symbicort®) 160/4.5 µg (delivered dose), budesonide 200 µg (metered dose), formoterol 4.5 µg or placebo. Severe exacerbations and FEV1(primary variables), peak expiratory flow (PEF), COPD symptoms, health-related quality of life (HRQL), mild exacerbations, use of reliever β2‐agonist and safety variables were recorded.Budesonide/formoterol reduced the mean number of severe exacerbations per patient per year by 24%versusplacebo and 23%versusformoterol. FEV1increased by 15%versusplacebo and 9%versusbudesonide. Morning PEF improved significantly on day 1versusplacebo and budesonide; after 1 week, morning PEF was improvedversusplacebo, budesonide and formoterol. Improvements in morning and evening PEFversuscomparators were maintained over 12 months. Budesonide/formoterol decreased all symptom scores and use of reliever β2‐agonists significantlyversusplacebo and budesonide, and improved HRQLversusplacebo. All treatments were well tolerated.These results suggest a role for budesonide/formoterol in the long-term management of moderate-to-severe chronic obstructive pulmonary disease.