![]() The study aims to enrol 1,800 patients across approximately 180 study centres globally. If successful, a once-daily triple combination would be an important addition to our portfolio of combination respiratory products partnered with GSK including Relvar ®/Breo ® Ellipta ® and Anoro ® Ellipta ®.” About the FULFIL studyįULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) is a randomised, double-blind, double-dummy, parallel group multicentre study evaluating once-daily FF/UMEC/VI (100mcg/62.5mcg/25mcg) inhalation powder versus twice-daily budesonide/formoterol (400mcg/12mcg). Aguiar, Chief Executive Officer of Theravance, added: “With FULFIL, we hope to demonstrate that a once-daily triple combination can reduce exacerbations in patients with COPD and deliver meaningful improvements in lung function and health related quality of life. By providing all three medicine components in a single inhaler we hope to offer more convenient dosing to patients, reduce the risk of exacerbation compared to dual therapy and, as a result, contribute to the improved management of their disease. The first, larger study in the phase III programme, known as IMPACT, started in July 2014 to assess whether FF/UMEC/VI can reduce the rate of moderate and severe exacerbations compared with two approved once-daily COPD treatments, Relvar/Breo Ellipta (FF/VI), an ICS/LABA combination, and Anoro Ellipta (UMEC/VI), a LAMA/LABA combination.ĭave Allen, Head, GSK Respiratory Therapy Area Unit, R&D, said: “Triple combination therapy is already a reality for one in three patients with COPD and is often dispensed in different inhalers with differing doses. Patient perspectives of efficacy and physical activity will also be evaluated versus budesonide/formoterol. Adverse events of particular interest include pneumonia and cardiovascular risk. Secondary objectives include investigating the effect on the rate of exacerbations with FF/UMEC/VI compared with budesonide/formoterol, and the safety profile of FF/UMEC/VI compared with budesonide/formoterol. (NASDAQ: THRX) today announced the start of a second global phase III study to evaluate the effects of the investigational once-daily closed triple combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with chronic obstructive pulmonary disease (COPD).Įnrolling approximately 1,800 patients, the FULFIL study will assess whether the inhaled corticosteroid, long-acting muscarinic antagonist and long-acting beta 2-adrenergic agonist (ICS/LAMA/LABA) combination, all delivered in GSK’s Ellipta ® inhaler, can improve lung function and health-related quality of life compared with budesonide/formoterol, a twice-daily ICS/LABA combination delivered via the Turbohaler ® dry powder inhaler. GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. Issued: London UK and South San Francisco, CA
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