GlaxoSmithKline (GSK) announced on March 19, 2010 that the first asthma patient has started treatment with Relovair™ (fluticasone furoate/vilanterol trifenatate) in an asthma exacerbation study, marking the start of the Phase III clinical development programme with this once daily therapy.The asthma programme for Relovair (previously referred to as ‘Horizon’) will assess the potential benefit of the combination of inhaled corticosteroid, fluticasone furoate, and long-acting beta agonist, vilanterol trifenatate versus the component products and existing treatments for asthma.
The programme will consist of a range of 8 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 6 efficacy studies are scheduled to start within the next quarter.
This study will evaluate Relovair 100/25mcg against fluticasone furoate 100mcg in patients whose asthma remains uncontrolled on current therapy. The primary endpoint - time to first severe asthma exacerbation - will inform on both safety and efficacy.
The ongoing 12 month safety study, will evaluate the overall safety profile of Relovair and has been designed to support both the asthma and COPD indications.
Patients across all of the Relovair programs will be dosed using a unique single step activation inhaler.
Relovair is being developed under the long-acting beta2 agonist (LABA) collaboration entered into in November 2002 with Theravance, Inc. a biopharmaceutical company with a pipeline of internally discovered product candidates.
References:
Risk of asthma exacerbations: Relative to SABA-only therapy, LABA use is associated with a lower risk of ED visit http://goo.gl/4sDc9
Image sources: Wikipedia, public domain, Advair Diskus.
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