Qva149 Provides Significant Symptomatic Benefit To Copd Patients As Measured By A New Symptom Ediary: The Shine Study

Introduction: The SHINE study evaluated the efficacy and safety of QVA149 (combination of indacaterol [IND] and glycopyrronium [GLY]), open-label tiotropium (TIO), IND, GLY, and placebo (PBO) in patients (pts) with COPD.Methods: A daily electronic symptom diary (e-diary) was used investigating 3 time domains (M1/symptoms since waking up; M2/symptoms since last evening assessment; E/symptoms since morning assessment) assessing severity and effect of five symptoms and two impact items of COPD on a 11 point scale in a subset of 209 pts , where 197 had valid post baseline values.Results: QVA149 provided significant improvements vs. PBO in COPD symptoms and their impact on pts as measured by e-diary. Mean change from baseline for QVA149 was clinically relevant (MCID -0.6 points) and statistically superior to PBO for symptoms of both domains E and M2. Daytime (E) results are summarised in the table. M2 showed similar results. Treatment | N Mean | Week 26; Mean Change (95% CI) | Difference vs Placebo (95% CI) | p-value |||| QVA149 | 39 2.37 | -0.82 (-1.17,-0.46) | -0.78 (-1.38,-0.19) | 0.0097 || IND | 45 3.00 | -0.84 (-1.17,-0.52) | -0.81 (-1.39,-0.23) | 0.0063 || GLY | 47 2.62 | -0.59 (-0.91,-0.27) | -0.56 (-1.14,0.01) | 0.0571 || TIO | 39 2.79 | -0.12 (0.47,0.22) | -0.09 (-0.69,0.50) | 0.7561 || PBO | 22 2.40 | -0.03 (-0.51,0.44) | | |* Changes in e-diary were correlated with TDI (-0.34, pu003c0.001) and FEV1 (-0.22 pu003c0.05) E assessments; N,number of patients in the treatment groupTable: Mean change from baseline after 26 wks; Component EConclusion: E-diary results show correlations with TDI and FEV1 and confirm that QVA149 improves COPD symptoms relevant for patientsu0027 daily lives.