Inhaled Glycopyrronium bromide ( Seebri Breezhaler; NVA237 ) is a once-daily, long-acting muscarinic receptor antagonist ( LAMA ) that is approved in several countries, as a maintenance bronchodilator for the symptomatic treatment of adult patients with chronic obstructive pulmonary disease ( COPD ).
In the randomized, controlled, phase III GLOW ( GLycopyrronium bromide in chronic Obstructive pulmonary disease airWays clinical study )-1 and -2 trials, treatment with inhaled Glycopyrronium bromide 50 mcg once daily was associated with significantly better lung function than placebo in patients with moderate to severe COPD in terms of the trough forced expiratory volume in one second ( FEV1 ) at 12 weeks ( primary endpoint ).
Significant between-group differences in trough FEV1 in favour of inhaled Glycopyrronium bromide were maintained for up to 52 weeks.
Dyspnoea scores, health status and exacerbation rates were also improved to a greater extent in the inhaled Glycopyrronium bromide than placebo groups in these trials.
In the randomized, controlled, phase III GLOW3 trial, inhaled Glycopyrronium bromide was associated with a significantly longer exercise endurance time than placebo after 3 weeks' treatment in patients with moderate to severe COPD.
The drug was generally well tolerated over the 26-week ( GLOW1 ) or 52-week ( GLOW2 ) study duration, and had a tolerability profile that was generally similar to that of Tiotropium bromide ( Spiriva ). Serious adverse events were consistent with those expected in patients with moderate to severe COPD.
In conclusion, inhaled Glycopyrronium bromide is a once-daily LAMA that is an effective bronchodilator for use in the treatment of patients with moderate to severe COPD. ( Xagena )
Carter NJ, Drugs 2013;73:741-753