Positive results in 3 Phase III studies of Anoro Ellipta for COPD-GSK/Theravance

GlaxoSmithKline and Theravance have announced positive results from three Phase III studies of Anoro Ellipta (umeclidinium/vilanterol) in patients with Chronic Obstructive Pulmonary Disease (COPD). Two studies compared the efficacy and safety of the combination Anoro Ellipta with Advair Diskus (fluticasone propionate/salmeterol) and the third compared the efficacy and safety of Anoro Ellipta with Seretide Diskus (FSC) in patients with COPD and no history of moderate to severe COPD exacerbations in the last year. In each of the studies UMEC/VI achieved a statistically significant improvement in lung function, measured as weighted mean forced expiratory volume in one second (wm FEV1) over 0-24 hours at the end of the 12 week study (day 84), compared to either dose of FSC. The incidence of any cardiovascular adverse events of special interest was similar in the different treatment groups.

Eligible patients were randomised to receive either UMEC/VI (62.5/25mcg) administered as a once-daily inhalation and placebo administered twice-daily, or FSC (500/50 mcg in study 116134 and 250/50mcg in studies 114930 and 114951) administered as a twice-daily inhalation and placebo administered once-daily. UMEC/VI was administered in the dry powder inhaler (DPI), Ellipta and FSC in the multi-dose powdered inhaler, Diskus. Approximately 2100 patients across the three studies were enrolled. The full results of will be presented at a future scientific meeting.