GlaxoSmithKline and partner Theravance have started a phase III trial of a triple therapy for chronic obstructive pulmonary disease (COPD) delivered using a single inhaler.
The two companies will test the combination of corticosteroid fluticasone furoate, long-acting muscarinic antagonist (LAMA) umeclidinium and long-acting beta agonist (LABA) vilanterol in a 10,000-patient trial that should complete sometime in 2017.
All three drugs will be delivering via GSK’s Ellipta inhaler, which is already used in the company’s recently introduced dual therapies Anoro (umeclidinium and vilanterol) and Relvar/Breo (fluticasone furoate and vilanterol).
The new study, called IMPACT is the first pivotal trial to evaluate a once-daily corticosteroid, LAMA and LABA combination in patients with COPD, according to GSK. The efficacy of the triple therapy will be compared to Anoro and Breo in the 52-week trial.
Dave Allen, head of the company’s respiratory R&D unit, said: “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.”
IMPACT will compare the effect of the three treatments on lung function, health related quality of life (HRQoL) measures, hospitalisation rates and rescue medication use in patients aged 40 or over with an established history of COPD.
GSK’s corticosteroid/eta agonist combination Advair/Seretide (fluticasone and salmeterol) has dominated the COPD market for years – racking up $7bn-a-year in sales – but has seen sales slide this year on the back of rising competition, downward pricing pressure and delisting from the formularies of some pharmacy benefits managers in the US.
Anoro and Breo have been positioned to help offset Advair’s sales declines, but are facing competition themselves from other COPD dual therapies, notably Novartis’ LAMA/LABA combination Ultibro (glycopyrronium and indacaterol) was approved in Europe last September.
Meanwhile, AstraZeneca, Boehringer/Pfizer and Forest Labs/Almirall are all bringing their own LAMA/LABA combinations through the pipeline, so GSK’s triple therapy approach could help it stay ahead of the pack.