GlaxoSmithKline said Friday that the development programme for its respiratory therapy Relovair has shifted up gear with the start of Phase III trials in asthma.
Relovair, which the UK drug giant is working on with US-based partner Theravance under a deal signed back in 2002, is
essentially a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta agonist vilanterol trifenatate, and is already being assessed in Phase III trials in patients with chronic obstructive pulmonary disease.
The Phase III asthma programme is designed to test whe
ther there is any benefit to giving patients Relovair as opposed to its component products or indeed other treatments for the condition, and the launch of the asthma exacerbation study complements a 12-month safety study rolled out under the umbrella of COPD trials, the group said.
The asthma exacerbation trial is a randomised, double-blind, parallel-group study taking place at sites across Europe, the US, and other international locations, although the US leg of the programme is yet to be finalised in lieu of changes proposed by the Food and Drug Administration regarding the use of LABA-containing products in asthma.
All-in-all, the Phase III asthma package will include eight studies to determine the efficacy and safety of the once-daily combination therapy – to be administered via a “unique” single step activation inhaler – in patients who have been unable to get their condition under control with current treatments. Six more efficacy studies are scheduled to start within the next quarter.
