GlaxoSmithKline (GSK) announced today that the first asthma patient has commenced treatment with Relovair
This asthma exacerbation study, marks the start of the Phase III clinical development programme for this serious and chronic disease.
The asthma programme for Relovair will review the potential benefit of the combination of inhaled corticosteroid, fluticasone furoate, and long-acting beta agonist, vilanterol trifenatate (642444) versus the component products and existing treatments for asthma.
The programme will comprise of 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.
GSK is in talks with the 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.
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