Meta-Analysis Plan for MID207941: A Study to Evaluate Risk Factors for Pneumonia and Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in a COPD Population of Patients Treated with GW685698+GW642444 (Fluticasone Furoate+Vilanterol); GW642444 (Vilanterol); CCI18781 (Fluticasone Propionate); GR33343 (Salmeterol); CCI1878+GR33343 (Fluticasone Propionate+Salmeterol) and Placebo

Trial description: The purpose of this meta-analysis is to evaluate the risk factors for pneumonia and COPD exacerbations in COPD subjects included in the following five randomized double blind parallel group studies: HZC102870, HZC102970, SCO100250, SCO40043 and SCO30003 (Towards a Revolution in COPD Health [TORCH]). The SCO studies (SCO100250, SCO40043 and SCO30003) included in meta-analysis, comprised of COPD subjects who were randomized to receive either fluticasone propionate(FP)/salmeterol (SAL) and SAL (SCO40043 and SCO100250) or FP/SAL, SAL, Placebo and FP (SCO30003). In HZC studies (HZC102870 and HZC102970), the COPD subjects were randomized to receive either fluticasone furoate (FF)/vilanterol (VI) or VI. Treatment comparisons will be made by pooling subjects into two groups (inhaled corticosteroid [ICS] treated and non-ICS treated) based on whether the subject was randomized to an ICS treatment alone or in combination, that is, FF in the HZC studies or FP in the SCO studies.