@article {SekiyaP2103, author = {Mitsuaki Sekiya and Tomotaka Kawayama and Yoshinosuke Fukuchi and Yota Takahashi and Tetsuya Kaiso and Kimitoshi Ikeda and Tim Overend and Donald Banerji}, title = {Safety and efficacy of NVA237 once daily in Japanese patients: The GLOW4 trial}, volume = {40}, number = {Suppl 56}, elocation-id = {P2103}, year = {2012}, publisher = {European Respiratory Society}, abstract = {Introduction: NVA237 (glycopyrronium bromide) is a once-daily (QD) inhaled long-acting muscarinic antagonist for the maintenance treatment of COPD.Methods: The primary objective of the 52-week, multi-center, randomized, open label, parallel group GLycopyrronium bromide in COPD airWays clinical study 4 (GLOW4) was to assess the safety and tolerability of NVA237 50{\textmu}g QD for 52 wks in Japanese patients with moderate-to-severe COPD. A secondary objective was to compare the safety and efficacy of NVA237 to open-label tiotropium 18 μg QD (TIO).Results: 163 patients were randomized (NVA237=123, TIO=40); 84\% completed. Mean age was 68.7 yrs, 97.5\% male. Overall adverse events (AE) incidence was similar between NVA237 and TIO. The only AEs with \>10\% incidence in any group were COPD worsening (24.4 and 32.5\%) and nasopharyngitis (30.9 and 32.5\%) for NVA237 and TIO, respectively. Serious AEs occurred in 13 and 15\% patients for NVA237 and TIO, respectively, with no deaths. There were no reports of notable pulse rate (\>130 bpm, or >=120 and +15 bpm from baseline) and QTc interval (Fridericia) \>500ms over 52 wks. Dry mouth incidence was less frequent with NVA237 (1.6\%) vs TIO (5\%). A clinically significant increase from baseline in pre-dose FEV1 was observed for NVA (101 mL) and TIO (173 mL) at Wk 12. The event-free rate for moderate or severe COPD exacerbation was 78.9\% for NVA237 and 76.6\% for TIO at Wk 52.Conclusion: NVA237 once daily had a safety and tolerability and efficacy profile similar to tiotropium in Japanese patients with moderate-to-severe COPD over 52 weeks.}, issn = {0903-1936}, URL = {https://erj.ersjournals.com/content/40/Suppl_56/P2103}, eprint = {https://erj.ersjournals.com/content/40/Suppl_56/P2103.full.pdf}, journal = {European Respiratory Journal} }