GSK and Theravance reveal positive results from three Phase III trials in COPD

18th March 2014 (Last Updated March 18th, 2014 01:00)

GlaxoSmithKline (GSK) and Theravance have reported positive results from three Phase III trials comparing Anoro Ellipta with Seretide Diskus and Advair Diskus in patients with chronic obstructive pulmonary disease (COPD).

GlaxoSmithKline (GSK) and Theravance have reported positive results from three Phase III trials comparing Anoro Ellipta with Seretide Diskus and Advair Diskus in patients with chronic obstructive pulmonary disease (COPD).

Out of the three, two trials compared the efficacy and safety of the combination anticholinergic / long-acting beta2-adrenergic agonist, Anoro Ellipta (umeclidinium/vilanterol, 'UMEC/VI') with inhaled corticosteroid / long-acting beta2-adrenergic agonist combination, Advair Diskus (fluticasone propionate/salmeterol 'FSC 250/50') in COPD patients .

The third compared the efficacy and safety of Anoro Ellipta with Seretide Diskus 'FSC 500/50' in patients with COPD and no history of moderate to severe COPD exacerbations in the last year.

"These findings add to the existing body of evidence and our understanding of the efficacy and safety of UMEC/VI."

In each trial, 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 with either dose of FSC.

GSK senior vice-president and head of global respiratory franchise Darrell Baker said: "These findings add to the existing body of evidence and our understanding of the efficacy and safety of UMEC/VI."

About 2,100 patients with post-salbutamol FEV1 of = 30% and = 70% and no history of moderate to severe COPD exacerbations in the last 12 months have participated in all the three 12-week multicentre, randomised, double-blind, double-dummy, parallel group trials (116134, 114930 and 114951).

In these trials, eligible patients were given either UMEC/VI (62.5/25mcg) 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.

The company said that UMEC/VI was administered in the dry powder inhaler (DPI), Ellipta and FSC in the multi-dose powdered inhaler, Diskus.