GSK’s Relovair moves into phase III
pharmafile | March 19, 2010 | News story | Research and Development | GlaxoSmithKline, Relovair, Seretide, Theravance, respiratory
GlaxoSmithKline has started phase III asthma trials of Relovair, the respiratory treatment it is developing with San Francisco biopharma firm Theravance.
Relovair combines GSK’s inhaler Seretide, itself a combination of fluticasone and salmeterol, with an inhaled corticosteroid and the long-acting beta agonist, vilanterol trifenatate (642444).
The drug began phase III trials for chronic obstructive pulmonary disease (COPD) last October and the asthma part of the study programme, which GSK previously referred to as Horizon, will test Relovair against its component products as well as other existing asthma treatments.
The programme will consist of a range of eight studies to determine the efficacy and safety of once-daily Relovair in asthma patients who remained uncontrolled on current treatment.
The study is a randomised, double-blind, parallel-group study being conducted in Europe and other international locations.
The US arm of the trial has yet to be finalised due to proposed FDA changes to the use of products containing long-acting beta 2 agonists, but GSK said it was in ongoing discussions with the US regulator.
The study’s primary endpoint – time to first severe asthma exacerbation – will inform on both safety and efficacy. In addition to this an ongoing 12-month safety study will evaluate the overall safety profile of Relovair to support both the asthma and COPD indications.
There will be six additional efficacy studies that will include: a 24-week head-to-head study of Relovair vs Advair/Seretide, a 24-week fluticasone furoate vs. fluticasone propionate vs. placebo study; a 12-week vilanterol trifenatate vs. salmeterol vs. placebo study; a 12-week low-dose combination study; and a 24-week higher dose combination study vs. components and an HPA axis study.
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