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 (Symbicort1) 160/4.5 mg (delivered dose), budesonide 200 mg (metered dose), formoterol 4.5 mg 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 b 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. 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 b 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. Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the world [1], with increasing prevalence and mortality predicted in the coming decades [2]. COPD is a serious and disabling disease, which imposes a large burden on patients, healthcare systems and society.In patients with COPD, lung function deteriorates progressively over several years with increasing symptoms (e.g. dyspnoea, chest tightness, cough and sputum production); acute exacerbations are common, particularly in later stages, and these have considerable impact on patients9 daily activities and well-being [3]. Cigarette smoking is the major aetiological factor in COPD and smoking cessation is the only factor which has been shown to influence the decline in forced expiratory volume in one second (FEV1) [4,5]. However, the COPD-related inflammatory process in the airways initiated by smoking persists after cessation of smoking [6], and effective treatment is needed in past smokers with COPD [7].The pharmacotherapy of COPD largely consists of mucolytics, bronchodilators, such as b 2 -agonists, anticholinergics, theophylline and anti-inflammatory drugs i.e. inhaled corticosteroids, often taken in combination [2]. Consequently, there is a need for better treatment options to relieve symptoms, reduce exacerbations and to provide better health-related quality of life (HRQL) for individual patients. The long-acting b 2 -agonists formoterol a...

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Background: Clinical studies suggest that inhaled corticosteroids reduce exacerbations and improve health status in chronic obstructive pulmonary disease (COPD). However, their effect on mortality is unknown. Methods: A pooled analysis, based on intention to treat, of individual patient data from seven randomised trials (involving 5085 patients) was performed in which the effects of inhaled corticosteroids and placebo were compared over at least 12 months in patients with stable COPD. The end point was all-cause mortality. Results: Overall, 4% of the participants died during a mean follow up period of 26 months. Inhaled corticosteroids reduced all-cause mortality by about 25% relative to placebo. Stratification by individual trials and adjustments for age, sex, baseline post-bronchodilator percentage predicted forced expiratory volume in 1 second, smoking status, and body mass index did not materially change the results (adjusted hazard ratio (HR) 0.73; 95% confidence interval (CI) 0.55 to 0.96). Although there was considerable overlap between subgroups in terms of effect sizes, the beneficial effect was especially noticeable in women (adjusted HR 0.46; 95% CI 0.24 to 0.91) and former smokers (adjusted HR 0.60; 95% CI 0.39 to 0.93). Conclusions: Inhaled corticosteroids reduce all-cause mortality in COPD. Further studies are required to determine whether the survival benefits persist beyond 2-3 years.