Biopharmaceutical company GlaxoSmithKline has announced the completion of patient recruitment for their study to evaluate the effectiveness of Relvar Ellipta (fluticasone furoate “FF”/vilanterol “VI” 100/25 mcg) for the treatment of chronic obstructive pulmonary disease (COPD). Dubbed a “Real-World” study by GSK, the year-long trial will be the first of its kind to collect data about how the drug impacts peoples’ daily lives, in addition to its safety and efficacy.
The Salford Lung Study will bring together GSK and other local healthcare providers to analyze Relvar Ellipta compared with other COPD therapies in 2,800 COPD patients who will be given daily doses of the drug for a year. The phase 3 open-label study aims to assess the real impact of the medication on a daily basis, with the mean annual rate of moderate and severe exacerbations serving as the study’ primary endpoint.
The most common way of evaluating drugs before approval is within carefully-controlled randomized controlled trials, conducted within a specific patient population. In addition, traditional studies tend to exclude participants with other conditions or co-morbidities in order to eliminate any influences to the results. However, these trials normally require additional information support the study outcomes and expand the knowledge about the effectiveness of the medication in real world situations. GSK aims to overcome these limitations by conducting a novel type of study that compiles this information along with a study of the drug’s performance.
The Salford Lung Study is expected to complete by the end of next year, and the company has announced that the first results will be released in 2016. In addition, GSK has been focused on COPD drug development, and has recently released results of a study that revealed an increase in the incidence of the disease in the United States. The “Continuing to Confront COPD International Patient Survey,” which was conducted to celebrate World Chronic Obstructive Pulmonary Disease Day on November, 19, evaluated the changes in the disease’s prevalence and burden and compared data within a 10-year period.