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Efficacy and Safety of Glycopyrrolate
Chronic Obstructive Pulmonary Diseases:
Journal of the COPD Foundation Original Research
Efficacy and Safety of Twice-Daily Glycopyrrolate Versus Placebo in Patients With COPD: The GEM2 Study Edward Kerwin, MD1 Thomas M. Siler, MD2 Phillip Korenblat, MD3 Alexander White, MD4 Joerg H. Eckert, PhD5 Michelle Henley, MSc6 Francesco Patalano, MD5 Peter D’Andrea, MD6
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 15.6μg in patients with moderate-to-severe airflow limitation. This 12-week multicenter, double-blind study randomized (1:1) patients to glycopyrrolate 15.6μg twice daily (b.i.d.) or placebo both delivered via the NeohalerTM 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 AUC0-12h) 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 FEV1 AUC0-12h). Compared with placebo, glycopyrrolate showed significant improvements in lung function parameters (p
Efficacy and Safety of Glycopyrrolate
Chronic Obstructive Pulmonary Diseases:
Journal of the COPD Foundation Original Research
Efficacy and Safety of Twice-Daily Glycopyrrolate Versus Placebo in Patients With COPD: The GEM2 Study Edward Kerwin, MD1 Thomas M. Siler, MD2 Phillip Korenblat, MD3 Alexander White, MD4 Joerg H. Eckert, PhD5 Michelle Henley, MSc6 Francesco Patalano, MD5 Peter D’Andrea, MD6
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 15.6μg in patients with moderate-to-severe airflow limitation. This 12-week multicenter, double-blind study randomized (1:1) patients to glycopyrrolate 15.6μg twice daily (b.i.d.) or placebo both delivered via the NeohalerTM 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 AUC0-12h) 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 FEV1 AUC0-12h). Compared with placebo, glycopyrrolate showed significant improvements in lung function parameters (p
