GlaxoSmithKline and Theravance have initiated a global Phase III trial to assess the safety and efficacy of the ‘closed’ triple combination in patients with chronic obstructive pulmonary disease (COPD).
IMPACT is the first Phase III trial in a programme to assess a once-daily closed triple combination treatment of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist in COPD patients.
The triple combination comprises of FF (fluticasone furoate, an ICS), UMEC (umeclidinium, a LAMA) and VI (vilanterol, a LABA).
A total of 10,000 patients across 38 countries will be enrolled in the double-blind, three-arm, parallel group trial, which will evaluate whether the triple combination delivered in GSK’s Ellipta inhaler can reduce the annual rate of moderate and severe exacerbations.
The trial will compare the triple combination with two approved once-daily COPD treatments; ICS/LABA combination Relvar/Breo Ellipta and Anoro Ellipta , which is a LAMA/LABA combination.
GSK head of respiratory therapy area unit, R&D, Dave Allen 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.
"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.
"The IMPACT study will be important in advancing our understanding of how the combination of FF/UMEC/VI could be used in this setting when compared to dual combination therapy options."
Theravance chief executive officer Rick Winningham said: "The start of the IMPACT study marks a significant milestone in our development programme with GSK and we are excited about the potential opportunity for a triple combination treatment approach.
"This Phase III programme has the potential to demonstrate the safety and efficacy profile of a new and important therapy that could deliver additional benefits and convenience to the growing number of adults living with COPD worldwide."
In the trial, eligible patients will be randomly to receive either FF/UMEC/VI 100/62.5/25mcg, FF/VI 100/25mcg or UMEC/VI 62.5/25mcg once-daily for a period of 52 weeks.
Co-primary endpoints of the trial are the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with FF/VI, and the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with UMEC/VI.
Image: A chest X-ray demonstrating severe chronic obstructive pulmonary disease (COPD). Photo: courtesy of James Heilman.