A great deal of research has been conducted worldwide to reduce the burden of Chronic Obstructive Pulmonary Disorder (COPD) among its patient population. Recently, a series of clinical trials tested the efficacy of moderately chronic COPD medications in reducing associated co-morbidities in patients. UK based pharma giants GlaxoSmithKline (GSK) and the biopharmaceutical company Theravance, recently stated in a report that they had concluded recruiting volunteers for the “Study to Understand Mortality and MorbidITy” (SUMMIT). This recent COPD study sought to measure the impact of Relvar/Breo Ellipta (fluticasone furoate/vilanterol) on patients either already diagnosed with or having a high risk of cardiovascular disease (CVD) along with COPD.
COPD causes millions of deaths worldwide annually. Severe co-morbidities that further complicate the health for COPD patients include heart disease, osteoporosis, diabetes, anemia, and anxiety among others. Chronic bronchitis and emphysema (two major conditions contributing to the development of COPD) cause a decrease in the number of blood vessels by constricting them chronically due to poor air passage and ventilation among the alveoli. This leads to failure of the right cardiac ventricle in pushing blood into the lungs effectively. This creates a very high blood pressure, ultimately resulting in heart failure.
Both Breo Ellipta and Relvar Ellipta have been approved by the FDA (in May of 2013), and the European Medicines Agency (November 2013) respectively, for use among patients with moderate to chronic COPD. However, none have been licensed anywhere in the world to be used for CVDs associated with COPD. This makes SUMMIT the first of a kind study which aims to do so.
Around 16,000 volunteers with moderate COPD and a history of or at increased risk of CVDs have been enrolled for SUMMIT. They are scheduled to undergo a double-blind, parallel-group, placebo-controlled study, receiving once-daily treatment with fluticasone furoate/vilanterol (100/25mcg), fluticasone furoate (100mcg), vilanterol (25mcg) or placebo. The primary end-point of the study is to compare the drug’s effectivity with a placebo with respect to mortality rates. The secondary end-points include a reduction in the amount of Forced Expiratory Volume (FEV) in 1 second and a composite cardiovascular end-point. The exact duration of this study is not mentioned ,but the volunteers are expected to participate for a minimum of 16 months (implying the minimum time needed for high-risk patients to see a measurable change) to a maximum of 53 months. This mainly depends on the severity of the condition.
Darrell Baker, SVP and head, global respiratory franchise, GSK said: “We are very pleased to have completed recruitment in this large study and initiated the final patient onto treatment. We hope that results from this study will increase our understanding of cardiovascular comorbidity in COPD, and of the effects of Relvar/Breo Ellipta when used to manage COPD.”
Adding to this, Rick Winningham, chief executive officer of Theravance said: “There is limited understanding of the relationship between COPD and cardiovascular disease or the potential to affect patient outcomes. We believe that, once available, the results from this landmark study will enhance our knowledge of these co-morbid conditions and provide important information about treatment with Relvar/Breo in a COPD population with cardiovascular risk factors.”
The results of this study may also be beneficial to other companies in the pharma sector, encouraging testing of new drugs targeting a particular disease and their efficiencies in treating associated co-morbidities.