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

TLDR

The study evaluated the efficacy and safety of budesonide/formoterol versus placebo, budesonide, and formoterol in patients with moderate‑to‑severe COPD. In a 12‑month randomized double‑blind placebo‑controlled trial of 812 adults, patients received two inhalations twice daily of budesonide/formoterol, budesonide, formoterol, or placebo, with severe exacerbations and FEV1 as primary outcomes and additional pulmonary function, symptom, quality‑of‑life, and safety measures recorded. Budesonide/formoterol lowered severe exacerbations by 24% versus placebo, increased FEV1 by 15% versus placebo, improved PEF and symptom scores, reduced reliever use, and enhanced quality of life, with all treatments well tolerated, supporting its use for long‑term management of moderate‑to‑severe COPD.

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 (FEV 1 ) 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 FEV 1 (primary variables), peak expiratory flow (PEF), COPD symptoms, health-related quality of life (HRQL), mild exacerbations, use of reliever β 2 ‐agonist and safety variables were recorded. Budesonide/formoterol reduced the mean number of severe exacerbations per patient per year by 24% versus placebo and 23% versus formoterol. FEV 1 increased by 15% versus placebo and 9% versus budesonide. Morning PEF improved significantly on day 1 versus placebo and budesonide; after 1 week, morning PEF was improved versus placebo, budesonide and formoterol. Improvements in morning and evening PEF versus comparators were maintained over 12 months. Budesonide/formoterol decreased all symptom scores and use of reliever β 2 ‐agonists significantly versus placebo and budesonide, and improved HRQL versus placebo. 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.