GSK begins Phase III Study of Relovair, a New Daily Treatment for Asthma

GlaxoSmithKline has begun a new phase III study of Relovair, its new daily treatment for sufferers of asthma according to press reports and press releases on the GSK website.

The pharmaceutical company revealed that the first patient to participate in the trial has now commenced treatment with the drug, which is an inhaler-administered therapy based on the compound fluticasone furoate/vilanterol trifenatate.

It has been developed in partnership with biopharmaceutical firm Theravance as part of the two companies’ long-acting beta2 agonist collaboration, which commenced in 2002.

This study, which is taking place across Europe and the US, will aim to establish the safety and efficacy of Relovair while comparing its performance to that of existing treatments for the condition.

The company expressed confidence that the treatment can prove to be a beneficial option for patients suffering from the “serious and chronic disease”.

Last week, the company received marketing authorization from the European Medicines Agency for Revolade, its treatment for chronic immune thrombocytopenic purpura.

GlaxoSmithKline commences Relovair Phase III asthma programme

GlaxoSmithKline (GSK) announced today that the first asthma patient has commenced 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, for this serious and chronic disease.

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 (642444) versus the component products and existing treatments for asthma.

The programme will consist of a range 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 ongoing discussions 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.

Study designs
The asthma exacerbation study is a randomised, double-blind, parallel-group study being conducted in Europe, the US and other international locations. 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.

The additional six efficacy studies comprise: 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.

Patients across all of the Relovair programmes will be dosed using a unique single step activation inhaler. This novel delivery device has been developed utilising GSK’s expertise in device development and valuable patient input.

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.

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