GlaxoSmithKline and Innoviva announced positive data from the Phase 3 FULFIL clinical trial evaluating their investigational triple combination therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/IV) in patients with chronic obstructive pulmonary disease (COPD).
FULFIL is a randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of a daily dose of the FF/UMEC/IV triple therapy vs. a twice-daily dose of Symbicort/Turbohaler (budesonide/formoterol), a therapy indicated for COPD treatment.
The study enrolled 1,810 patients, 911 of which were randomized to the FF/UMEC/IV group and 899 to the budesonide/formoterol group. Patients were treated across 162 centers worldwide.
After 24 weeks, the patients on the triple therapy group demonstrated significant improvements in lung function and health-related quality of life, compared to those in the budesonide/formoterol group. Particularly, the proportion of patients who exhibited a clinically relevant difference in quality of life was 50 percent in the group of patients taking FF/UMEC/VI vs. 41 percent in the budesonide/formoterol group.
The incidence of serious adverse effects — the most common being COPD worsening, nasopharyngitis, and headache — was similar in both groups (5.4 percent vs. 5.7 percent).
To provide long-term safety data on the triple therapy, 430 of the initial patients remained on the study for 52 weeks. By the end of that time, patients on the budesonide/formoterol group had more serious adverse effects than those in the FF/UMEC/VI treatment group (12.7 percent vs. 10 percent).
Both companies believe that the findings from the FULFIL trial will support regulatory submission in the European Union for the closed triple combination for COPD patients, as well as the submission of a New Drug Application to the U.S. FDA, both by the end of 2016.
“We are delighted with the outcome of the FULFIL study, which marks a further step toward making this closed triple combination therapy available to appropriate patients with COPD,” said Dave Allen, head of Respiratory R&D at GSK, in a press release. “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.”
“With the FULFIL study, we have shown meaningful improvements in lung function and health-related quality of life when combining three COPD medicines in a single inhaler, compared to the dual therapy of budesonide/formoterol,” said Innoviva CEO Mike Aguiar.
“If approved, 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,” Aguiar said.