PT  - JOURNAL ARTICLE
AU  - W. Szafranski
AU  - A. Cukier
AU  - A. Ramirez
AU  - G. Menga
AU  - R. Sansores
AU  - S. Nahabedian
AU  - S. Peterson
AU  - H. Olsson
TI  - Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease
AID  - 10.1183/09031936.03.00031402
DP  - 2003 Jan 01
TA  - European Respiratory Journal
PG  - 74--81
VI  - 21
IP  - 1
4099  - http://erj.ersjournals.com/content/21/1/74.short
4100  - http://erj.ersjournals.com/content/21/1/74.full
SO  - Eur Respir J2003 Jan 01; 21
AB  - 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% versus placebo and 23% versus formoterol. FEV1 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 β2‐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. This study was supported by AstraZeneca.