Novartis has announced positive data from its phase III trial of once-daily inhaled glycopyrronium bromide (NVA237) in patients with chronic obstructive pulmonary disease (COPD).

The GLOW2 trial showed that once-daily inhaled glycopyrronium bromide (NVA237) improved lung function in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) compared to placebo (p<0.001), with similar efficacy to open-label tiotropium.

The GLOW2 trial was a 52-week double-blind, placebo-controlled, parallel-group study in 1066 patients with moderate-to-severe COPD who were randomised into three treatment arms receiving either once-daily glycopyrronium bromide 50 mcg, placebo, or once-daily open-label tiotropium 18 mcg. Patients were also permitted to use COPD background therapy and rescue medication. The study met its primary endpoint by demonstrating superior 24-hour bronchodilation vs. placebo at 12 weeks as measured by trough FEV1. It also produced similar improvements in lung function compared to open-label tiotropium (Spiriva® HandiHaler®) though this part of the study was not powered to show statistical superiority of these two agents. The GLOW2 study also showed that there was a similar incidence of adverse events amongst the three treatment arms.

In April 2011 Novartis announced results from the first phase III trial (GLOW1), a double-blind 26-week study which also met its primary endpoint by demonstrating superior bronchodilation to placebo at 12 weeks (p<0.001). Further data from GLOW1 will be presented at the European Respiratory Society congress in September 2011.

Further efficacy and safety results from GLOW2 will be presented at a scientific congress in 2012, and the data will be used to support an application for regulatory approval to be filed before the end of 2011. Novartis also plans to file for regulatory approval of QVA149, the fixed-dose combination of glycopyrronium bromide and indacaterol, expected to occur in 2012.