GlaxoSmithKline and Innoviva’s three-drug inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) has come out on top in a trial assessing its effectiveness against the dual therapy Symbicort Turbohaler in patients with chronic obstructive pulmonary disorder (COPD).
The FULFIL study met its two co-primary endpoints, showing statistically significant improvements with the closed triple therapy compared with Symbicort Turbohaler (budesonide/formoterol) in both lung function as measured by trough FEV1 (+171 mL) and health-related quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ; -6.6 versus -4.3, respectively).
Also, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50 percent on closed triple and 41 percent on Symbicort Turbohaler, the firm said.
The study showed a statistically significant and clinically meaningful reduction in the annual rate of moderate/severe exacerbations with FF/UMEC/VI compared to budesonide/formoterol, with closed triple therapy showing a 35 percent reduction based on data up to 24 weeks and a 44 percent reduction in the subset of patients that received treatment for up to 52 weeks.
On the safety side, the incidence of investigator-reported serious adverse events for closed triple and Symbicort Turbohaler, respectively, was 5.4 percent and 5.7 percent up to 24 weeks, and 10.0 percent and 12.7 percent up to 52 weeks.
“Exacerbations are a major cause of morbidity in COPD and reducing these symptomatic and potentially life-threatening episodes is a priority for physicians. To observe such significant reductions in exacerbations with closed triple therapy versus budesonide/formoterol is encouraging and supports our belief that a convenient, once-daily triple therapy dosing option delivered via a single inhaler could provide compelling and clinically important treatment benefits in this more severe patient population,” said Dave Allen, Head of Respiratory R&D at GSK, commenting on the results.
GSK said plans for regulatory submissions of the closed triple combination therapy for COPD in the US and Europe by the end of the year are on schedule.
