Around 1,800 patients will be enrolled from across 180 study centres globally in this randomized, double-blind, double-dummy, parallel group multicentre Phase III FULFIL trial.
The trial is designed to evaluate once-daily FF/UMEC/VI (100mcg/62.5mcg/25mcg) inhalation powder versus twice-daily budesonide/formoterol (400mcg/12mcg).
Secondary objectives of the trial include examining the effect on the rate of exacerbations as well as the safety profile of FF/UMEC/VI compared with budesonide/formoterol.
GSK Respiratory Therapy Area Unit, R&D head Dave Allen said: "Triple combination therapy is already a reality for one in three patients with COPD and is often dispensed in different inhalers with differing doses.
"By providing all three medicine components in a single inhaler we hope to 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."
In the trial the inhaled corticosteroid, long-acting muscarinic antagonist and long-acting beta2-adrenergic agonist (ICS/LAMA/LABA) combination will be delivered in the company’s Ellipta inhaler.
Theravance chief executive officer Michael Aguiar said: "With FULFIL, we hope to demonstrate that a once-daily triple combination can reduce exacerbations in patients with COPD and deliver meaningful improvements in lung function and health related quality of life.
"If successful, a once-daily triple combination would be an important addition to our portfolio of combination respiratory products partnered with GSK including Relvar/Breo Ellipta and Anoro Ellipta."
According to the company the closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.
Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.