Efficacy and Safety of Twice-Daily Glycopyrrolate Versus Placebo in Patients With COPD: The GEM2 Study.

ABSTRACT: Long-acting bronchodilators including muscarinic antagonists are central to the management of patients with COPD. The Glycopyrrolate Effect on syMptoms and lung function (GEM2) study assessed the efficacy and safety of twice-daily glycopyrrolate 15.6 μg in patients with moderate-to-severe airflow limitation. This 12-week multicenter, double-blind study randomized (1:1) patients to glycopyrrolate 15.6 μg twice daily (b.i.d.) or placebo both delivered via the Neohaler^TM device. The primary objective was superiority of glycopyrrolate compared with placebo for forced expiratory volume in 1 second (FEV₁) standardized area under curve (AUC) between 0 and 12 hours post dosing (FEV₁ AUC_0-12h)at week 12. Other outcomes included additi

SUBMITTER: Kerwin E 

PROVIDER: S-EPMC5559157 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature