Once-daily glycopyrronium improves lung function and reduces exacerbations in severe-to-very severe COPD patients: The SPARK study

Introduction Glycopyrronium (NVA237) and tiotropium (TIO) are once-daily (OD) inhaled long-acting muscarinic antagonists for the treatment of COPD. Here we present the efficacy results of glycopyrronium (GLY) vs TIO in patients with COPD from the SPARK study. Methods This 64-week, multicenter, parallel-group, active-controlled study randomized patients ≥40 yrs with severe-to-very severe COPD and a history of exacerbations to receive double-blind QVA149 110/50µg or GLY 50µg or open-label TIO 18µg OD. COPD exacerbations, lung function (pre-dose forced expiratory volume in 1 second [FEV 1 ]), St. George’s Respiratory Questionnaire (SGRQ) scores and rescue medication use were analyzed. Results 1483 patients were randomized, 99.5% analyzed (GLY=739, TIO=737); male: 74%. At Week 64, the reduction in the rate of COPD exacerbations in the GLY group was comparable to TIO (Rate ratio [RR]: 1.01, 95% confidence interval [CI]: 0.913, 1.107, p=0.919). The pre-dose FEV 1 (LS Mean [SE], L) was similar for GLY (0.98 [0.011]) and TIO (0.99 [0.011]). SGRQ score improvement (LS Mean [SE]) with GLY (45.46 [0.780]) was similar to TIO (46.08 [0.778]). The reduction in daily rescue medication usage was comparable for both GLY and TIO. Conclusion Once-daily GLY showed similar efficacy in reducing exacerbations, improving lung function and health status, and reducing rescue medication use as TIO in patients with severe-to-very severe COPD.