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.
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\nGlaxoSmithKline (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.
\nThe 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.
\nThe 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.
\nGSK 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.
\nThe 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.
\nThe 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.
\nPatients 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.
\nRelovair 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.
\nGlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
\n\nGlaxoSmithKline Enquiries:\n | \n\n | \n |
| \n UK Media enquiries: \n | \n\n Philip Thomson \n | \n\n (020) 8047 5502 \n | \n
| \n \n | \n\n Claire Brough \n | \n\n (020) 8047 5502 \n | \n
| \n \n | \n\n Stephen Rea \n | \n\n (020) 8047 5502 \n | \n
| \n \n | \n\n Alexandra Harrison \n | \n\n (020) 8047 5502 \n | \n
| \n \n | \n\n Jo Revill \n | \n\n (020) 8047 5502 \n | \n
| \n \n | \n\n \n | \n\n \n | \n
| \n US Media enquiries: \n | \n\n Nancy Pekarek \n | \n\n (919) 483 2839 \n | \n
| \n \n | \n\n Mary Anne Rhyne \n | \n\n (919) 483 2839 \n | \n
| \n \n | \n\n Kevin Colgan \n | \n\n (919) 483 2839 \n | \n
| \n \n | \n\n Sarah Alspach \n | \n\n (919) 483 2839 \n | \n
| \n \n | \n\n | \n |
| \n European Analyst/Investor enquiries: \n | \n\n David Mawdsley \n | \n\n (020) 8047 5564 \n | \n
| \n | \n Sally Ferguson \n | \n\n (020) 8047 5543 \n | \n
| \n | \n Gary Davies \n | \n\n (020) 8047 5503 \n | \n
| \n | \n | \n |
| \n US Analyst/ Investor enquiries: \n | \n\n Tom Curry \n | \n\n (215) 751 5419 \n | \n
| \n | \n Jen Hill Baxter \n | \n\n (215) 751 7002 \n | \n
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.
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