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Background
In 2001, we concluded that 'as-required' short-acting inhaled beta2 agonists improve lung function and relieve breathlessness in patients with stable COPD, and that patients not adequately controlled by such treatment can be helped by regular use of an inhaled antimuscarinic bronchodilator or a long-acting beta2 agonist. 4 We also stated that the place of inhaled corticosteroids in stable COPD was controversial. Our conclusion was that, on current evidence, such therapy should be reserved for patients with COPD who have a forced expiratory volume in 1 second (FEV 1 ) below 50% of the predicted normal and frequent exacerbations. 4 In the UK, no inhaled corticosteroids are licensed for use alone in the treatment of COPD.
Seretide
Seretide is licensed for the symptomatic treatment of patients with severe COPD (FEV1 below 50% of predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. 1 For COPD, it is available in a dry-powder inhaler (Seretide 500 Accuhaler) that delivers fluticasone propionate 500µg and salmeterol xinafoate 50µg in one inhalation. The licensed dose is one inhalation twice daily.
Efficacy
Three published double-blind randomised placebo-controlled trials have compared the efficacy of a combination product of fluticasone + salmeterol with fluticasone or salmeterol alone, all taken via a dry-powder inhaler. 5 - 7
In one trial, 691 patients with moderate to severe COPD (mean FEV1 41% of predicted) were treated for 24 weeks with fluticasone 500µg + salmeterol 50µg, fluticasone 500µg alone, salmeterol 50µg alone or placebo, all taken twice daily. 5 The primary outcome measures were changes in pre-dose (i.e. trough) and 2-hour post-dose FEV 1 . The pre-dose primary measure was used to compare the combination inhaler with salmeterol, and fluticasone with placebo; the 2-hour post-dose primary measure was used to compare the combination inhaler with fluticasone, and salmeterol with placebo. At the end of the study, mean increase in pre-dose FEV 1 was greater with the combination inhaler than with salmeterol alone (156mL vs. 107mL, p=0.012), and greater with fluticasone alone than with placebo (109mL vs. -4mL, p<.001). There was a greater increase in 2-hour post-dose FEV1 with the combination inhaler than with fluticasone alone (261mL vs. 138mL, p<.001), and with salmeterol alone than...