NVA237 once daily reduces the percentage of patients with exacerbations of COPD and associated hospitalizations: The GLOW1 trial

Abstract

Introduction: COPD exacerbations, especially those leading to hospitalization, have a significant impact on patients' quality of life and long-term prognosis. We examined the influence of the once-daily (QD) long-acting muscarinic antagonist NVA237 (glycopyrronium bromide) on exacerbations of COPD.

Methods: Patients with moderate-to-severe COPD were randomized (2:1) to double-blind NVA237 50 μg QD or placebo (PBO) via a low-resistance single-dose dry powder inhaler (Concept1 device) for 26 wks. In addition to bronchodilation (primary efficacy endpoint was trough FEV₁ at 12 wks), the effect on COPD exacerbations and related hospitalizations was assessed using a Cox regression model.

Results: 822 patients were randomized; 80.5% completed. Mean age was 63.9 yrs, mean post-bronchodilator FEV₁ 54.6% predicted (FEV₁/FVC 0.5). Compared with PBO, NVA237 significantly prolonged the time to first moderate/severe COPD exacerbation (hazard ratio [HR] 0.69, 95% confidence interval [CI]: 0.50–0.949; p=0.023) and the time to first severe COPD exacerbation leading to hospitalization (HR 0.35, 95% CI: 0.141–0.857; p=0.022). NVA237 also significantly reduced the percentage of hospitalizations due to COPD exacerbation (odds ratio [OR] 0.34; p=0.024). NVA237 numerically reduced the rate of moderate/severe exacerbations with NVA237 vs PBO (0.43 vs 0.59/yr; rate ratio [RR] 0.72; p=0.071).

Conclusion: In patients with moderate-to-severe COPD, compared with placebo, NVA237 50 μg once daily significantly prolonged the time to first moderate/severe COPD exacerbation and reduced the percentage of hospitalizations due to a COPD exacerbation.