Pooled analysis of the assessment of the association of lung function improvements on COPD related exacerbations and other endpoints

Trial description: Chronic Obstructive Pulmonary Disease (COPD) exacerbations are not easy to predict, but several approved pharmacotherapies have shown ability to reduce exacerbations when used regularly. The mechanism behind reducing COPD exacerbations with pharmacologic treatments are not fully elucidated. Both an anti-inflammatory effect and a sustained increase in airway patency and reduction in hyperinflation, have been invoked in reversing the patho-physiology of exacerbations. The objective of this study is to characterize the relationship between lung function improvement and subsequent COPD exacerbations using data from identified COPD clinical trials sponsored by GlaxoSmithKline (GSK).The data sources for this study include all GlaxoSmithKline (GSK)-sponsored, randomized, blinded, controlled COPD clinical trials of at least 6 months in duration with pharmacological intervention and for which lung function assessments (including Forced Expiratory Volume in One Second (FEV1)) were measured at baseline and at least at 1 additional time point within 8-12 weeks of randomization, COPD-related exacerbations were captured in a systematic fashion as a study outcome, and electronic data are available. The study design is a meta analysis.