We conclude that fluticasone propionate/salmeterol 250/50 is more effective than salmeterol at reducing the rate of moderate to severe exacerbations over 1 year. The benefits of this reduction relative to the risk of a higher incidence of reported pneumonia should be considered. This study supports the use of fluticasone propionate/salmeterol 250/50 for the reduction of COPD exacerbations in patients with COPD.

Many studies have shown that correlation between clinical asthma status and asthma-specific quality of life is only weak to moderate. However, this relationship has never been explored to determine whether the weakness is due to noise of measurement or whether quality of life is a distinct component of asthma health status.With a database from three clinical trials (n=763), factor analysis was used to explore the relationships between quality of life, measured by the Asthma Quality of Life Questionnaire (AQLQ), and conventional measures of asthma clinical status (symptoms, airway calibre and rescue b 2 -agonist use).The analysis revealed that although patients with severe, poorly controlled asthma tend to have worse quality of life than milder, well-controlled patients, overall asthma health status has four components (factors): asthma-specific quality of life; airway calibre; daytime symptoms and daytime b 2 -agonist use, and night-time symptoms and night-time b 2 -agonist use.The clean loading of all 21 outcomes onto four distinct and clinically identifiable factors suggests that, although some weakness of correlation between clinical indices and quality of life may be due to noise of measurement, it is mainly attributable to asthma health status being composed of distinct components. Identifying and treating impaired health-related quality of life is now recognised as an important component of asthma management. International guidelines identify that treatments should not only improve asthma clinical status, and thus reduce the risk of exacerbations and possibly airway remodelling, but should also enable patients to feel and function better in their day-to-day lives [1]. Asthma-specific quality of life questionnaires have been developed and validated so that this aspect of patient management can be accurately measured and treatment effectiveness assessed [2][3][4]. These questionnaires are now used in both clinical trials [5] and clinical practice [6] alongside the more traditional clinical measures of airway status such as airway calibre, symptoms and markers of inflammation.The rationale for including both clinical and quality of life measures has been based on the observation that correlations between these two measures are only weak to moderate and therefore patient experiences cannot be imputed from the clinical variables [2][3][4][7][8][9]. Correlations between symptoms and asthma-specific quality of life rarely exceed a Pearson correlation coefficient of 0.6 [2][3][4][7][8][9], and correlations between quality of life and airway calibre are usuallyv0.2 and rarely statistically significant [2,3,[7][8][9]. Despite the consistency of these observations [2][3][4][7][8][9], it has been argued that these poor correlations arise through imprecision of measurement (both of clinical status and of quality of life).To determine whether the weakness of association is solely attributable to noise of measurement or whether quality of life is a distinct component of asthma health status, a factor analysis w...

Prevention and treatment of COPD exacerbations are recognized as key goals in disease management. This randomized, double-blind, parallel-group, multicenter study evaluated the effect of fluticasone propionate/salmeterol 250 mcg/50 mcg (FSC 250/50) and salmeterol 50 mcg (SAL) twice-daily on moderate/severe exacerbations. Subjects received treatment with FSC 250/50 during a one month run-in, followed by randomization to FSC 250/50 or SAL for 52 weeks. Moderate/severe exacerbations were defined as worsening symptoms of COPD requiring antibiotics, oral corticosteroids and/or hospitalization. In 797 subjects with COPD (mean FEV(1) = 0.98L, 34% predicted normal), treatment with FSC 250/50 significantly reduced the annual rate of moderate/severe exacerbations by 30.4% compared with SAL (1.10 and 1.59 per subject per year, respectively, p < 0.001), the annual rate of exacerbations requiring oral corticosteroids by 34% (p < 0.001) and the annual rate of moderate/severe exacerbations requiring hospitalization by 36% (p = 0.043). Clinical improvements observed during run-in treatment with FSC 250/50 were better maintained over 52 weeks with FSC 250/50 compared to SAL. Statistically significant reductions in albuterol use, dyspnea scores, and nighttime awakenings and numerical benefits on quality of life were seen with FSC 250/50 compared with SAL. The incidence of adverse events was similar across groups. Pneumonia was reported more frequently with FSC 250/50 compared with SAL (7% vs. 2%). FSC 250/50 is more effective than SAL at reducing the rate of moderate/severe exacerbations. These data confirm the beneficial effect of FSC on the management of COPD exacerbations and support the use of FSC in patients with COPD.

No abstract