NVA237 BID Versus Placebo Twelve-week Efficacy Study

Summary

The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

Timeline

Start

2012-11

Primary completion

2013-12

Completion

2013-12

Outcome

Met primary endpoint

paper The study met its primary objective (superiority of glycopyrrolate compared with placebo for FEV1 AUC0-12h). PMID 28848879 ↗

Publications

• Kerwin E, Siler TM, Korenblat P, White A, Eckert JH, Henley M, Patalano F, D'Andrea P. Efficacy and Safety of Twice-Daily Glycopyrrolate Versus Placebo in Patients With COPD: The GEM2 Study. Chronic Obstr Pulm Dis. 2016 Mar 28;3(2):549-559. doi: 10.15326/jcopdf.3.2.2015.0157.

Drugs

Indications