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.
- © 2011 ERS