The trial is designed to evaluate the contribution of the ICS component on lung function, in patients with Chronic Obstructive Pulmonary Disease (COPD).
According to GSK, positive results from the trial will help support a potential filing of FF/VI for the treatment of patients with COPD in Japan.
The trial is a 12 week, multicenter, randomized, double-blind, parallel-group study to assess the efficacy and safety of FF/VI 100/25mcg once daily compared with VI 25mcg once daily, administered via the Ellipta inhaler.
Patients enrolled in the trial will have a history of COPD with at least one exacerbation in the year prior to screening.
About 1580 patients are expected to be enrolled in the trial from across 250 centres worldwide, including around 350 patients from centres in Japan.
The FF/VI Phase III clinical development programme in COPD patients included data from six studies in over 6,000 COPD patients.
Specific Japanese patient efficacy data were only available from two six-month efficacy studies, in which the contribution of FF 100mcg to the combination, on lung function, did not achieve statistical significance.
Image: GlaxoSmithKline headquaters in London. Photo: Courtesy of Maxwell Hamilton