TY - JOUR T1 - Effect of QVA149 on lung function in the subgroup of patients with a history of exacerbations in the previous year and baseline ICS use from the SHINE study JF - European Respiratory Journal JO - Eur Respir J VL - 44 IS - Suppl 58 SP - P918 AU - Kenneth R. Chapman AU - Eric D. Bateman AU - Petter Olsson AU - Hungta Chen AU - Donald Banerji AU - Robert Fogel Y1 - 2014/09/01 UR - http://erj.ersjournals.com/content/44/Suppl_58/P918.abstract N2 - IntroductionQVA149 is an approved, once-daily dual bronchodilator combination of LABA, indacaterol (IND), and LAMA, glycopyrronium bromide (GLY), for the maintenance treatment of symptomatic COPD. The SHINE study compared QVA149 with its mono-components, open-label tiotropium (OL TIO) and placebo (PBO). Here, we report the subgroup analysis of patients (pts) with history of ≥1 exacerbation and who used inhaled corticosteroids (ICS) at baseline in SHINE.MethodsSHINE was a 26-wk, multicentre, parallel-group study that randomised pts with moderate-to-severe COPD (2:2:2:2:1) to receive QVA149 110/50μg, IND 150μg, GLY 50μg, OL TIO 18μg or PBO. This post-hoc analysis studied the effect of QVA149 on trough (t) FEV1 and tFVC vs comparators using a linear mixed model in pts with ≥1 exacerbation (in the previous year) and baseline ICS use.ResultsIn total, 542 pts (out of 2135 in full-analysis set; 25.4%) had a history of exacerbations. Of them, 465 (85.8%) pts were included in this subgroup analysis who used ICS at baseline and were continued on fixed ICS doses (Table). At Wk 26, QVA149 significantly improved tFEV1 and tFVC vs comparators with the exception of non-significant improvement vs GLY for tFVC (Table).View this table:Table: Lung function at Wk 26ConclusionIn pts with a history of ≥1 exacerbation and baseline ICS use, QVA149 provided greater improvement in lung function vs IND, GLY, OL TIO or PBO. ER -