![]() ![]() This is a four arm, multicentre, randomised, double-blind, parallel-group study, with treatment administered once daily via a novel dry powder inhaler. Cardiovascular risk factors remain a very important cause of morbidity and mortality in this disease and this study is crucial to assessing whether Relovair can benefit these patients”. ![]() This study will evaluate the clinical outcomes of patients receiving standard cardiovascular care (including cardiovascular medications) versus patients receiving FF/VI in addition to receiving standard cardiovascular care (including cardiovascular medications).ĭarrell Baker, Senior Vice President for the GSK Respiratory Medicines Development Centre, commented, “This Relovair study demonstrates our commitment to evaluating survival outcomes for patients with COPD throughout the world. Secondary objectives will evaluate the effect of FF/VI compared with placebo on the rate of decline in lung function, as well as on cardiovascular endpoints including cardiovascular death, heart attacks and strokes. The primary objective is to prospectively evaluate the effect of the combination (FF/VI, 100/25mcg) compared with placebo on survival in COPD patients with moderate disease and a history of, or at risk from, cardiovascular disease. The additional study is an extensive outcomes trial across 1,100 global sites and will run alongside the existing COPD programme. About the Relovair Outcomes StudyįF/VI commenced Phase III development for COPD in October 2009 and the programme now includes approximately 6,000 patients across five pivotal registration studies. The Phase III programme will investigate two doses of ‘719 (125mcg and 62.5mcg) and ‘719/VI (125/25mcg and 62.5/25mcg) across the six further studies, which will all commence within the next quarter. The study initiated today is a 52-week randomised study to evaluate the long term safety and tolerability of ‘719 (125mcg) alone, as well as the combination with ‘719/VI (125/25mcg). These molecules act through two mechanisms: antagonism of acetylcholine muscarinic receptors and agonism of beta 2 adrenoreceptors.The medicine will be administered using a new dry powder inhalation device. ‘719/VI combines two bronchodilator molecules currently under development - ‘719, a long-acting muscarinic antagonist (LAMA) and VI, a long-acting beta agonist (LABA). Relovair is a once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) combination treatment, currently under development, comprising fluticasone furoate and vilanterol (FF/VI). The second is the start of an extensive study of 16,000 patients to assess the potential for Relovair to improve survival in those with COPD and a history of, or at risk from, cardiovascular disease. The programme will also include two further studies assessing the effect of ‘719/VI on exercise endurance. Patients are now being enrolled in a large safety study, which will be followed shortly by four large pivotal studies that will compare improvements in lung function between ‘719/VI, its components, placebo and tiotropium. The first is the initiation of the Phase III programme for the once-daily LAMA/LABA dual bronchodilator GSK573719/vilanterol (‘719/VI), which will evaluate over 5,000 patients globally. (NASDAQ: THRX) today announced major milestones in two clinical development programmes focused on new treatments for patients with chronic obstructive pulmonary disease (COPD), a leading cause of chronic illness and death worldwide. GlaxoSmithKline (GSK) and Theravance, Inc. Issued: London UK and South San Francisco, CA Relovair™ programme expanded by start of large Phase IIIb COPD outcomes study ![]()
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