GSK’s triple COPD combination therapy meets two co-primary endpoints in phase III study

Under the double-blind, double-dummy, parallel group FULFIL study, 1,810 patients were randomized to receive either GSK’s fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or budesonide/formoterol.

The study met its objectives, with the triple therapy showing significant improvements in lung function compared to AstraZeneca’s product and also improving patients’ self-reported quality of life scores.

It demonstrated statistically significant improvements compared with twice-daily Symbicort Turbohaler (budesonide/formoterol 400/12mcg) in both lung function as measured by trough FEV1 (171mL, 95% confidence interval [148, 194] p<0.001), and health-related quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ).

Patients in the FF/UMEC/VI cohort experienced a statistically significantly greater increase in FEV1 while half of them achieved the minimum clinically important difference in SGRQ of -4 units, compared to 41% for budesonide/formoterol).

GSK head of respiratory R&D Dave Allen said: "Triple combination therapy is already a reality for many patients with COPD and is dispensed in multiple inhalers.

"By combining three medicines in a single inhaler we can offer a convenient, once-daily dosing option to patients while improving their symptoms."

GSK plans to file for approval of the triple therapy in both Europe and the US by the end of the year.