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

• Published in: Chronic obstructive pulmonary diseases 2016-03, Vol.3 (2), p.549-559
• Main Authors: Kerwin, Edward, Siler, Thomas M, Korenblat, Phillip, White, Alexander, Eckert, Joerg H, Henley, Michelle, Patalano, Francesco, D'Andrea, Peter
• Format: Article
• Language: English
• Subjects: Original Research
• ISSN: 2372-952X; 2372-952X
• DOI: 10.15326/jcopdf.3.2.2015.0157

Long-acting bronchodilators including muscarinic antagonists are central to the management of patients with COPD. The lycopyrrolate ffect on sy ptoms 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 device. The primary objective was superiority of glycopyrrolate compared with placebo for forced expiratory volume in 1 second (FEV ) standardized area under curve (AUC) between 0 and 12 hours post dosing (FEV AUC )at week 12. Other outcomes included additional spirometry parameters, health status using St George's Respiratory Questionnaire (SGRQ), dyspnea via Transition Dyspnea Index (TDI), rescue medication use and COPD symptoms reported by patients via the electronic diary. Safety was also assessed. Of the 432 patients randomized (glycopyrrolate, n=216; placebo, n=216), 96% completed the planned treatment phase. The study met its primary objective (superiority of glycopyrrolate compared with placebo for FEV AUC ).Compared with placebo, glycopyrrolate showed significant improvements in lung function parameters (