RT Journal Article
SR Electronic
T1 NVA237 once daily provides rapid, clinically meaningful and sustained 24-h bronchodilation in patients with COPD: The GLOW1 trial
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP p866
VO 38
IS Suppl 55
A1 A. D'Urzo
A1 G. Ferguson
A1 M. Kato
A1 S. Atis
A1 C. Martin
A1 V.K.T. Alagappan
A1 D. Banerji
A1 Y. Lu
A1 T. Overend
YR 2011
UL http://erj.ersjournals.com/content/38/Suppl_55/p866.abstract
AB Introduction: NVA237 (glycopyrronium bromide) is a once-daily (QD) inhaled long-acting muscarinic antagonist in development for the treatment of COPD.Methods: Patients with moderate-to-severe COPD were randomized (2:1) to double-blind NVA237 50 μg QD or placebo (PBO) for 26 wks. Study medication was administered via a low-resistance single-dose dry powder inhaler (Concept1 device). The primary efficacy endpoint was trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose values) vs PBO after 12 wks.Results: A total of 822 patients were randomized; 80.5% completed the study. Mean age was 63.9 yrs, mean post-bronchodilator FEV1 was 55% predicted. At Wk 12 there was a statistically significant and clinically relevant difference between NVA237 vs PBO in mean trough FEV1 (108 mL; p<0.001). Trough FEV1 was also significantly higher at Day 1 and Wk 26 (treatment difference: 105 mL and 113 mL, respectively; p<0.001). At all time points on Day 1, Wk 12 and Wk 26, NVA237 demonstrated statistically superior (p<0.001) and clinically meaningful improvement in FEV1 compared with PBO. NVA237 had a rapid onset of action with an increased FEV1 of 93 mL at 5 min and 144 mL at 15 min vs PBO after the first dose on Day 1 (p<0.001). The incidence of adverse events (AEs) was similar between NVA237 and PBO (57.5% vs 65.2%, respectively). Serious AEs were reported by 7.5% of NVA237- vs 9.0% of PBO-treated patients.Conclusion: NVA237 50 μg once daily was safe and well tolerated, and produced clinically meaningful bronchodilation that was rapid in onset and maintained for 24 hrs throughout the study.