GlaxoSmithKline plc (LSE: GSK) today presented data at the American Thoracic Society (ATS) from a late-stage clinical study. In this study the safety and efficacy of the addition of a long-acting muscarinic antagonist (also known as an anticholinergic), umeclidinium 'UMEC' 62.5mcg (Incruse™ Ellipta®) and UMEC 125mcg, to the inhaled corticosteroid and long-acting beta2 agonist combination medicine, fluticasone proprionate and salmeterol 'FSC 250/50 mcg' (Advair ® Diskus®), was evaluated in chronic obstructive pulmonary disease (COPD) patients over 12 weeks.
The study showed that, for the primary endpoint of trough FEV1 at Day 85, the addition of UMEC (at either dose) to FSC 250/50 mcg resulted in a statistically significant improvement in lung function when compared with placebo added on to FSC 250/50 mcg, in patients with COPD.
The addition of UMEC (at either dose) to FSC 250/50mcg also demonstrated statistically significant improvements in secondary efficacy endpoints of 0-6 hour weighted mean FEV1 at Day 84 and mean number of puffs of rescue medicine per day (weeks 1-12) compared with the addition of placebo to FSC 250/50 mcg.
Darrell Baker, SVP and Head, Global Respiratory Franchise, GSK said: "We are pleased to be able to share these results with physicians from across the world at this international congress. The ATS provides a forum for scientific discussion and we look forward to understanding the scientific and healthcare communities' perspectives of these new data."
There were no notable differences between UMEC (at either dose) added to FSC 250/50 mcg and placebo added to FSC 250/50 mcg in incidence rates of on-treatment adverse events or in changes from baseline in vital signs.