8:11AM Theravance and GlaxoSmithKline (GSK) announce topline results from Relovair vs Advair Phase 3 studies in COPD (THRX) 18.62 : Two replicate 12-week superiority studies evaluated the 24-hour lung function profile of once-daily FF/VI 100/25mcg (Relovair) compared with twice-daily Advair 250/50mcg (fluticasone propionate "FP"/salmeterol "SAL" (FP/SAL)) in patients with COPD. Each study randomised approximately 500 patients. In the first study, FF/VI demonstrated superiority over FP/SAL on the predefined primary endpoint of 0-24 hour weighted mean FEV1 (p<0.001). In the second study, FF/VI demonstrated numerical improvements but not statistical superiority over FP/SAL on the predefined primary endpoint of 0-24 hour weighted mean FEV1 (p=0.267).
GSK has also completed the phase III registrational programme for FF/VI, following the completion of a study to evaluate the efficacy and safety of FF and FP compared to placebo in the treatment of persistent asthma in adults and adolescents. In this 24-week multi-centre study of approximately 330 patients, FF met the primary endpoint of a statistically significant change from baseline in trough evening FEV1 at the end of the 24-week treatment period (p=0.009) compared to placebo. FP also met this primary endpoint when compared to placebo (p=0.011).
For COPD, GSK continues with its plans to submit regulatory applications for FF/VI in the US and Europe in mid-2012. For asthma, GSK plans to submit an application in Europe in mid-2012 and will continue discussions with the FDA on the regulatory requirements for a US asthma indication
surf's up......crikey
