TY - JOUR T1 - Safety of once-daily glycopyrronium in patients with severe-to-very severe COPD: The SPARK study JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P3389 AU - Marc Decramer AU - Jadwiga A. Wedzicha AU - Joachim H. Ficker AU - Angel FowlerTaylor AU - Peter D'Andrea AU - Christie Arrasate AU - Hungta Chen AU - Donald Banerji Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P3389.abstract N2 - IntroductionGlycopyrronium (NVA237) is a once-daily (OD) inhaled long-acting muscarinic antagonist for the treatment of COPD. Here we present the safety profile of glycopyrronium versus tiotropium in patients with COPD from the SPARK study.MethodsThis 64-week, multicenter, parallel-group, active-controlled study randomized patients ≥40 years with severe-to-very severe COPD and a history of exacerbations to receive double-blind QVA149 110/50µg or glycopyrronium 50µg (via the Breezhaler® device) or open-label tiotropium (via the Handihaler® device) 18µg OD. Safety was assessed by recording adverse events (AEs) and serious AEs (SAEs), and assessment of electrocardiograms, hematology, clinical chemistry, urinalysis, physical condition, and vital signs (pulse, blood pressure).ResultsThe table shows the summary of safety results. The overall safety profile was similar for glycopyrronium and tiotropium.View this table:Table: AEs, SAEs and deathsConclusionIn the SPARK study, glycopyrronium showed an overall good safety profile in patients with severe-to-very severe COPD that was similar to tiotropium. ER -