NVA237 once daily improves dyspnea and health-related quality of life (HRQoL) in patients with COPD: The GLOW1 trial

Introduction: A high level of unmet need exists in the treatment of COPD patients. NVA237 (glycopyrronium bromide) is a once-daily (QD) long-acting muscarinic antagonist in development for the treatment of COPD. Methods: Patients with moderate-to-severe COPD were randomized (2:1) to 26 wks' double-blind treatment with NVA237 50 μg QD or placebo (PBO) administered via a low-resistance single-dose dry powder inhaler (Concept1 device). In addition to FEV 1 (primary endpoint: trough FEV 1 after 12 wks) efficacy was assessed by symptoms (via the transition dyspnea index [TDI]), HRQoL (via the St George's Respiratory Questionnaire [SGRQ]), and rescue medication use. Results: A total of 822 patients (mean age 63.9 yrs; post-bronchodilator FEV 1 54.6% predicted) were randomized; 80.5% completed. At Wk 26, NVA237 significantly increased total TDI focal score vs PBO (difference: 1.04, p<0.0001) exceeding the minimum clinically important difference ([MCID] ≥1 point). The% of patients achieving a MCID in TDI score was significantly higher with NVA237 vs PBO (62.5% vs 50.8%; odds ratio [OR] 1.74; p=0.001). NVA237 significantly reduced rescue medication use vs PBO after 26 wks of treatment (–0.46 puffs/day, p=0.005). SGRQ total score was significantly reduced with NVA237 vs PBO (–2.81; OR 1.58; p=0.004). The% of patients achieving a clinically meaningful improvement in SGRQ (≥4 point reduction) was significantly higher with NVA237 vs PBO (56.3% vs 46.0%; p=0.006). Conclusion: NVA237 50 μg once daily provided a significant and clinically relevant improvement in dyspnea at 26 wks vs PBO, which was accompanied by a significant improvement in HRQoL and reduced rescue medication use.