Throughout the GLOW2 study, NVA237 was well-tolerated with a similar incidence of adverse events to placebo and OL tiotropium. Serious adverse events were reported less frequently with NVA237 (12.6%) than with either placebo (15.4%) or OL tiotropium (15.0%).
GLOW2 was a 52-week double-blind, placebo-controlled, parallel-group study involving 1,066 patients to assess the efficacy, safety and tolerability of NVA237 in patients with COPD. Patients were randomized into three treatment arms receiving either once-daily NVA237 50 mcg or placebo (double-blind), or once-daily OL tiotropium 18 mcg. They were also permitted to use COPD background therapy and rescue medication.
Phase II clinical trial update
Results have recently been submitted for publication from the NVA237 Phase II A2208 study. This study comparing once-daily and twice-daily dosing regimens of NVA237 met its primary endpoint by demonstrating that all treatments (12.5 mcg, 25 mcg and 50 mcg given once or twice daily and 100 mcg once daily) provided statistically significant bronchodilation over the course of the day (measured by mean trough FEV1 at Day 28) in patients with moderate-tosevere COPD compared to placebo.
Differences in lung function (measured by FEV1 AUC0-24h) between a single daily dose of NVA237 and the same total amount given twice daily were small and not clinically relevant. However once-daily dosing is known to offer the potential to improve patient adherence, an important consideration when selecting the optimum dosing regimen for a novel bronchodilator. Throughout the study, NVA237 showed an overall good safety profile and was well tolerated compared to placebo. The results of A2208 are consistent with previous NVA237 studies and support once-daily dosing of 50 mcg NVA237 in patients with moderate-to-severe COPD.
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