Abstract
The GLISTEN trial studied triple therapy - long-acting muscarinic antagonist added to fixed-dose combined inhaled corticosteroid and long-acting beta2-agonist - in Chronic Obstructive Pulmonary Disease (COPD).
GLISTEN was a randomised blinded placebo controlled trial in patients with moderate to severe COPD comparing glycopyrronium (GLY) 50 µg, tiotropium (TIO) 18 µg or placebo (each once-daily), added to fluticasone/salmeterol (FLU/SAL) 500/50 µg twice daily. The primary objective was to determine non-inferiority of GLY vs TIO (added to FLU/SAL) on trough FEV1 after 12 wks.
A total of 773 patients (mean age 68 yrs; post-bronchodilator FEV1 57.2% predicted) were randomized, 84.9% completed. At week 12, GLY demonstrated non-inferiority to TIO when added to FLU/SAL for trough FEV1: least square mean treatment difference (LMS diff) -7ml (SE 17.4), with statistically and clinically significant improvements in trough FEV1 at Week 12 with GLY added to FLU/SAL versus FLU/SAL alone (LSM diff 101ml, p<0.001). GLY (added to FLU/SAL) produced statistically significant improvement in health status after 12 wks versus FLU/SAL alone (SGRQ total score LMS diff -2.154, p=0.02). GLY (added to FLU/SAL) also demonstrated significant reduction in rescue medication use versus FLU/SAL alone (LSM diff -0.72 puffs/day; p<0.001). The incidence of adverse events (AEs) (58.4%, 64%, 57.6%) and serious AEs (5.8%, 8.5%, 5.8%) was comparable between GLY, TIO and placebo (added to FLU/SAL), respectively.
Compared to FLU/SAL alone, GLY 50 µg added onto FLU/SAL demonstrated significant improvements in lung function, health status and rescue medication use.
- © 2014 ERS