RT Journal Article
SR Electronic
T1 QVA149 showed significant improvements in lung function and health status and was well tolerated versus glycopyrronium and tiotropium in patients with severe COPD: The SPARK study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1893
VO 44
IS Suppl 58
A1 Jadwiga A. Wedzicha
A1 Anthony D'Urzo
A1 Karen Mezzi
A1 Hungta Chen
A1 Donald Banerji
A1 Robert Fogel
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/1893.abstract
AB IntroductionQVA149 is an approved once-daily (OD) dual bronchodilator combination of the LABA indacaterol (IND) and LAMA glycopyrronium (GLY) for the maintenance treatment of patients (pts) with symptomatic COPD. We evaluated the effect of QVA149 versus GLY and tiotropium (TIO) on lung function, health status and safety in the subgroup of pts with severe COPD from the SPARK study.MethodsSPARK was a 64-week, multicentre, double-blind, parallel-group, active-controlled study that randomised (1:1:1) severe-to-very severe pts with COPD to OD QVA149 110/50 µg, GLY 50 µg, or open-label TIO 18 µg. Efficacy parameters included pre-dose FEV1 and health status (SGRQ). Safety data was also recorded.ResultsOf the 2224 randomised pts, 1742 (78.3%) had severe COPD (GOLD 2008) [QVA149=578; GLY=583; TIO=581]. In pts with severe COPD, pre-dose FEV1 was significantly higher with QVA149 at all time-points compared with GLY and TIO (p<0.0001 for both, table). At Week 64, SGRQ total score was significantly lower in the QVA149 group than GLY (treatment difference [TD]: -2.56; p=0.002) or TIO (TD: -3.38; p<0.001) groups. The incidence of adverse events were similar across all groups (QVA149=92.9%; GLY=93.0%; TIO=94.1%).View this table:Pre-dose FEV1 over 64 weeks (mL)ConclusionIn patients with severe COPD, QVA149 resulted in significant improvements in lung function and health status compared with GLY and TIO with a safety profile similar to that of both GLY and TIO.