Glycopyrronium bromide ( NVA237; Seebri Breezhaler ) is a once-daily long-acting muscarinic antagonist ( LAMA ) in development for chronic obstructive pulmonary disease ( COPD ).
The GLOW2 ( GLycopyrronium bromide in COPD airWays clinical Study 2 ) trial has evaluated the efficacy and safety of Glycopyrronium bromide in moderate-to-severe COPD over 52 weeks.
Patients were randomised 2:1:1 to Glycopyrronium bromide 50 mcg, placebo or open-label Tiotropium 18 mcg for 52 weeks.
Primary end-point was trough forced expiratory volume in 1 s ( FEV1 ) at 12 weeks.
A total of 1,066 patients was randomised, 810 completed the study.
At week 12, trough FEV1 increased significantly by 97 mL with Glycopyrronium bromide ( 95% CI 64.6-130.2; p less than 0.001 ) and 83 mL with Tiotropium ( 95% CI 45.6-121.4; p less than 0.001 ).
Compared with placebo, Glycopyrronium bromide has produced significant improvements in dyspnoea ( Transition Dyspnoea Index at week 26; p=0.002 ) and health status ( St George's Respiratory Questionnaire at week 52; p less than 0.001 ).
Glycopyrronium bromide has significantly reduced the risk of moderate-to-severe COPD exacerbations by 34% ( p=0.001 ) and the use of rescue medication ( p=0.039 ), versus placebo.
Glycopyrronium bromide-placebo and Tiotropium-placebo differences were comparable for all outcomes.
Safety profiles were similar across groups.
In conclusion, Glycopyrronium bromide 50 mcg has provided significant improvements in lung function, dyspnoea, health status, exacerbations and rescue medication use, versus placebo, and was comparable to Tiotropium.
Glycopyrronium bromide can potentially be an alternative choice of LAMA for COPD patients. ( Xagena )
Kerwin E et al, Eur Respir J 2012; 40:1106-1114