GlaxoSmithKline and Innoviva’s triple-combination therapy of fluticasone furoate, umeclidinium and vilanterol significantly reduced the amount of exacerbations experienced by patients with chronic obstructive pulmonary disease compared with AstraZeneca’s Symbicort Turbohaler, according to phase 3 study results presented at the 2016 European Respiratory Society International Congress.
“Exacerbations are a major cause of morbidity in chronic obstructive pulmonary disease (COPD), and reducing these symptomatic and potentially life-threatening episodes is a priority for physicians,” Dave Allen, head of respiratory R&D at GlaxoSmithKline, said at the meeting.
Researchers enrolled 1,810 patients with COPD in the double blind FULFIL study. Participants were randomly assigned to receive either a once-daily dose of a combination of fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI) or a twice-daily dose of a combination of budesonide and formoterol (Symbicort Turbohaler).
Results showed that patients in the triple-combination therapy group had improved lung function and a significantly reduced rate of COPD–related exacerbations. The researchers reported that they observed a 35% and 44% reduction of exacerbations in the FF/UMEC/VI group versus the Symbicort Turbohaler group at 24 and 52 weeks, respectively.
“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,” Allen said.
“The results of the FULFIL study confirm that the closed triple therapy of FF/UMEC/VI is superior to dual therapy of budesonide/formoterol on the key measures of lung function, quality of life and exacerbation reduction,” Mike Aguiar, CEO of Innoviva added. “These results contribute to the medicine’s positive benefit/risk profile and increase understanding of the clinical value of triple therapy in those patients that physicians decide would benefit from triple therapy versus dual therapy alone.”
GlaxoSmithKline reports that its regulatory submissions in the United States and Europe are on course for COPD treatment by the end of 2016. – by Alaina Tedesco
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