GlaxoSmithKline, Theravance initiate pivotal trial of triple combination therapy for COPD

GlaxoSmithKline and Theravance announced Wednesday the start of a Phase III trial investigating the triple combination of fluticasone furoate, umeclidinium and vilanterol, delivered via the Ellipta inhaler, in patients with chronic obstructive pulmonary disease (COPD). The companies noted that the IMPACT study is the first pivotal trial to evaluate a once-daily closed triple combination of an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta-adrenergic agonist in this indication.

Dave Allen, head of GlaxoSmithKline Respiratory Therapy Area Unit, R&D, said "when developing our respiratory portfolio we recognised the need to offer a range of molecules that could be co-formulated in different combinations to meet the needs of individual patients." He added "we know from the scientific literature and prescribing data that there are already COPD patients who receive three medicines in different inhalers, for whom a once-daily treatment in a single ‘closed’ device could be valuable."

GlaxoSmithKline and Theravance recently reported Phase III data showing that lung function in patients with COPD was significantly improved by combining umeclidinium, which is marketed as Incruse Ellipta, with Breo Ellipta (fluticasone/ vilanterol) versus Breo Ellipta alone.

The IMPACT study will randomise approximately 10 000 patients with COPD to receive triple therapy of fluticasone furoate, umeclidinium and vilanterol, or treatment with Breo Ellipta or Anoro Ellipta (umeclidinium/vilanterol) once daily for a period of 52 weeks. The trial's main goal is to compare the annual rate of moderate and severe exacerbations between the triple combination and the two other arms, while secondary endpoints include baseline changes in lung function, time to first moderate or severe exacerbation and the annual rate of severe exacerbations.

Earlier this month, Japanese regulators approved Anoro Ellipta for the relief of various symptoms caused by airway obstruction in patients with COPD, while the therapy is also cleared in Europe, the US and Canada. Breo Ellipta was approved by the FDA for COPD in May 2013, while the therapy was later granted approval by European regulators for the same indication, as well as for asthma, under the name Relvar Ellipta. The product is also marketed in Japan under the Relvar Ellipta brand as a treatment for bronchial asthma, while GlaxoSmithKline and Theravance withdrew their Japanese application for the medicine in the COPD indication last July.

For related analysis, see ViewPoints: GlaxoSmithKline starts pivotal-stage quest for 'holy grail' in COPD therapy.

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