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GSK announces positive results of Seretide study in patients with COPD
London | Thursday, March 30, 2006, 08:00 Hrs  [IST]

GlaxoSmithKline plc announces preliminary results from the TORCH study (TOwards a Revolution in COPD Health) which show a 17 per cent relative reduction in mortality over three years for patients receiving Seretide 50/500µg(EU) /Advair (US) (salmeterol/fluticasone propionate) as compared with patients on placebo (p=0.052).

This is the first study to investigate the effects of pharmacotherapy on all-cause mortality in patients with COPD. The primary comparison was between Seretide/Advair and placebo, a GSK release stated.

Seretide/Advair also reduced the rate of COPD exacerbations by 25 per cent compared to placebo (p<0.001) and resulted in an improvement in quality of life when compared to placebo as measured by the St George's Respiratory Questionnaire (SGRQ) (p<0.001).

Adverse events seen in the study generally appear consistent with those seen in previous studies of Seretide/Advair in patients with COPD. Despite the reduced rate of exacerbations overall Seretide/Advair was associated with increased reporting of adverse events classified under lower respiratory tract infections, when compared with placebo (p<0.001).

GSK believes these data are clinically important and that they will have a positive impact on the future management of COPD. GSK will be working with regulatory authorities to incorporate these study findings into our prescribing information for Seretide/Advair (50/500µg).

A multi-centre, multinational, double-blind trial, TORCH enrolled over 6,100 patients with COPD into one of four treatment arms; Seretide/Advair (50/500µg), Serevent (salmeterol) (50µg), Flixotide Flovent (fluticasone propionate) (500µg) or placebo over a treatment period of three years. The primary endpoint was all-cause mortality comparing Seretide/Advair with placebo and secondary endpoints were COPD exacerbations and quality of life. GSK will seek publication of the study in a peer-reviewed journal at the earliest opportunity.

Advair 50/500 is not licensed in the US for patients with COPD.

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