GSK and Theravance Announce Progression of LAMA/LABA Combination Treatment Into Phase III Development for COPD
News Feb 04, 2011
GlaxoSmithKline (GSK) and Theravance, Inc. have 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.
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.
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 programme will also include two further studies assessing the effect of '719/VI on exercise endurance.
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. 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).