Phase III trials begin for Relovair

The first asthma patient has commenced treatment with GlaxoSmithKline's (GSK) Relovair in a phase III programme.

The programme for Relovair will review the potential benefit of the combination of inhaled corticosteroid, fluticasone furoate, and long-acting beta agonist (LBA), vilanterol trifenatate (642444) versus the component products and existing treatments for asthma.

The programme, which is being conducted in Europe, the US and other international locations, will comprise eight studies to determine the efficacy and safety of Relovair in asthma patients who remained uncontrolled on current treatment.

The initiation of the exacerbation study complements a 12-month safety study that is already underway in support of the COPD programme. An additional six efficacy studies, including three comparator studies, are scheduled to start within the next quarter.

Relovair is being developed under the long-acting beta2 agonist (LABA) collaboration entered into in November 2002 with Theravance, a biopharmaceutical company with a pipeline of internally discovered product candidates.

GSK is in talks with the US Food & Drugs Association (FDA) regarding the US component of the global asthma programme following the recent FDA Advisory Committee meeting and the FDA's proposed changes to the use of LABA-containing products in asthma.