GSK,Theravance Start Phase III Lung Function Study For COPD - Quick Facts

(RTTNews) - GlaxoSmithKline Plc. (GSK.L, GSK) and Theravance, Inc. (THRX) Monday announced the start of a second global phase III study to evaluate the effects of the investigational once-daily closed triple combination of fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI in patients with chronic obstructive pulmonary disease or COPD.

Enrolling about 1,800 patients, the FULFIL study will assess whether the inhaled corticosteroid, long-acting muscarinic antagonist and long-acting beta2-adrenergic agonist (ICS/LAMA/LABA) combination, all delivered in GSK's Ellipta inhaler, can improve lung function and health-related quality of life compared with budesonide/formoterol, a twice-daily ICS/LABA combination delivered via the Turbohaler dry powder inhaler.

Secondary objectives include investigating the effect on the rate of exacerbations with FF/UMEC/VI compared with budesonide/formoterol, and the safety profile of FF/UMEC/VI compared with budesonide/formoterol.

Adverse events of particular interest include pneumonia and cardiovascular risk. Patient perspectives of efficacy and physical activity will also be evaluated compared to budesonide/formoterol.