GSK initiates Triple Therapy FULFIL study for COPD compared to budesonide/formoterol

GlaxoSmithKline and Theravance have 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 (FF/UMEC/VI) in patients with chronic obstructive pulmonary disease (COPD). Enrolling approximately 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 versus budesonide/formoterol.

Comment:The Phase III IMPACT trial was launched in July 2014 to determine whether FF/UMEC/VI can cut the rate of moderate and severe exacerbations compared with two approved once-daily COPD treatments, Relvar/Breo Ellipta (FF/VI) and Anoro Ellipta (UMEC/VI). GSK believes that by providing all three medicine components in a single inhalerit will offer more convenient dosing to patients, reduce the risk of exacerbation compared to dual therapy and, as a result, contribute to the improved management of their disease.