Meta-Analysis to evaluate the impact of exacerbations on Health-Related Quality of Life, FEV1, risk of further exacerbations, and mortality using data from GSK COPD observational studies and those for Fluticasone Propionate, Salmeterol/Fluticasone Propionate, Fluticasone Furoate/Vilanterol, and mepolizumab

Trial description: Economic models for COPD have traditionally been driven by forced expiratory volume in 1 second (FEV1), whereby both subjects severity and disease progression is mainly defined through FEV1. The mepolizumab COPD de-novo economic model, currently under development, proposes a novel approach to modeling of COPD disease progression, where mepolizumab-eligible COPD subjects disease progression is characterized in terms of the occurrence of moderate and severe exacerbations.The aim of this meta-analysis is to provide estimates of the impact of moderate and severe exacerbations on the changes in health-related quality of life (HRQoL), changes in airflow limitation, risk of further exacerbations, and risk of mortality to support the development of the economic model which will ultimately be used to support global reimbursement of mepolizumab. In addition the proposed analyses will provide a preliminary understanding of how clinically important deterioration (CID) can be used as a potential end point to support future reimbursement activities. The proposed analysis will be carried out to verify whether the occurrence of exacerbations or CID leads to a worsening of HRQoL, worsening of airflow limitation, increase in the risk of exacerbations and increase in the risk of mortality.This subject level meta-analysis will include data from GSK COPD studies including observational studies and interventional trials conducted for fluticasone propionate (FP), salmeterol (SAL)/FP, fluticasone furoate (FF)/ vilanterol (VI), and mepolizumab. The requirement to include GSK COPD studies only is because of the need to access subject level data.