Abstract
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.
- © 2011 ERS