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This randomised, double blind, parallel group, placebo controlled study funded by GlaxoSmithKline assessed treatment with salmeterol, fluticasone, and the combination of these two drugs for 1 year in a total of 1465 patients of whom 1009 completed the study. Pre-bronchodilator FEV1 was increased by all three treatments compared with placebo (p⩽0.0063) and by combined treatment with fluticasone and salmeterol compared with the individual drugs and placebo (p<0.0001). All three active treatments resulted in a reduction in the exacerbation frequency, although there was no significant difference between the treatment groups. However, combined treatment significantly reduced breathlessness and the use of reliever medication compared with the other groups. The combined treatment group showed a reduction in night time awakenings and an improvement in St George’s Respiratory Questionnaire scores that were significantly greater than in the placebo or salmeterol groups. The treatments were well tolerated with no differences in adverse events except for an increased frequency of oropharyngeal candidosis in the fluticasone (7%) and combination (8%) groups.
This large well designed study clearly shows, as one might intuitively expect, that the combination of two drugs previously shown to benefit lung function, symptoms, and health status results in a significant improvement in lung function and exacerbation frequency and thereby provides a promising treatment for selected patients with COPD.