The efficacy and safety of nebulized glycopyrrolate inhalation solution (GLY), administered twice daily (BID) via the innovative eFlow ® Closed System nebulizer (PARI Pharma GmbH, Starnberg, Germany), were demonstrated in two replicate, placebo-controlled, 12-week Phase III studies (GOLDEN 3 and GOLDEN 4). This report evaluates the efficacy and safety of GLY by baseline disease severity and age in the pooled GOLDEN 3 and GOLDEN 4 patient population (N=1,294).
Patients were grouped by baseline predicted post-bronchodilator FEV 1 (<50%, ≥50%) and age (<65, ≥65, ≥75 years).
GLY (25 and 50 μg BID) produced significant improvements in trough FEV 1 in FEV 1% predicted <50% (0.070 L, 0.079 L) and ≥50% (0.112 L, 0.126 L) subgroups ( P<0.01 vs placebo), and in patients aged <65 (0.056 L, 0.086 L), ≥65 (0.140 L, 0.124 L), and ≥75 (0.144 L, 0.120 L) years ( P<0.05 vs placebo). St George’s Respiratory Questionnaire (SGRQ) total score was significantly improved with GLY 25 and 50 μg BID ( P<0.05 vs placebo) in FEV 1% predicted <50% (−3.237, −3.061) and ≥50% (−3.392, −2.322) and in <65 years (−3.447, −2.318) and ≥65 years (−3.053, −3.098) subgroups. In patients aged ≥75 years, GLY 25 μg reduced SGRQ total score by −6.278 units ( P<0.01 vs placebo). The incidence of treatment-emergent adverse events was similar between GLY and placebo across all subgroups, and the overall incidence of cardiovascular events was low.