Relationship between change in trough FEV1 and COPD patient outcomes: Pooled analysis of 23 clinical trials in patients with COPD

Introduction: Measuring change in FEV 1 u0026 COPD patient reported outcomes (PROs) such as SGRQ u0026 TDI, rescue medication use u0026 exacerbations are important to assess the overall effect of therapy in COPD patients (pts). However, the relationship between these changes has been rarely reported. We analysed 23 clinical trials in COPD patients treated with LABA [indacaterol (IND), salmeterol u0026 formoterol], LAMA [glycopyrronium (GLY) u0026 tiotropium] u0026 LABA/LAMA dual bronchodilator (QVA149, fixed-dose combination of IND+GLY) to determine the relationship between change in trough FEV 1 u0026 PROs. Methods: Individual patient pooled data from randomised, parallel-group, placebo or active controlled studies (3 to18 months; 23,213 pts) were analysed. Results: A significant correlation between improvement in trough FEV 1 u0026 other endpoints was seen: exacerbations R s = 0.05; rescue medication, SGRQ, TDI r = 0.11-0.16, all p 1 had on average better SGRQ u0026 TDI scores, used less rescue medication u0026 had fewer exacerbations. The SGRQ score differed by 7.1 between the decile of pts with the lowest u0026 highest response in FEV 1 (figure1). Conclusions: At a population level, statistically significant and clinically relevant relationships exist between improvements in trough FEV 1 and COPD PROs, but the correlations are too weak to be useful at an individual patient level.