Abstract
Background
In a head to head comparison, the LANTERN study evaluated QVA149 once daily (LABA/LAMA) versus SFC twice daily (LABA/ICS) in patients (pts) with moderate to severe COPD.
Methods
In this double-blind, double-dummy, parallel-group study, 744 pts with moderate to severe COPD and who may have had a recent history of exacerbation (post-bronchodilator FEV1 ≥30% and <80% of the predicted normal) were randomised (1:1) to QVA149 110/50μg o.d. or SFC 50/500μg b.i.d. for 26 weeks (wks). Primary endpoint: Non-inferiority (NI) between QVA149 and SFC for post-dose trough FEV1 at Wk 26. Other endpoints: FEV1 AUC0-4hr, TDI, SGRQ, exacerbations and safety.
Results
Overall 676 pts (90.9%) completed the study. At Wk 26, QVA149 demonstrated NI followed by statistically significant superiority to SFC for trough FEV1 (treatment difference (Δ) =75mL, 95% confidence interval (CI): 44, 107mL; p<0.001). QVA149 demonstrated statistically significant improvement in FEV1 AUC0-4h at Wk 26 vs SFC (Δ=122mL; p<0.001). At Wk 26 for change from baseline, QVA149 and SFC had similar improvements in TDI and SGRQ total scores, and rescue medication use. QVA149 significantly reduced the rate of moderate or severe exacerbations by 31% (RR [95% CI]: 0.69 [0.48, 1.00]; p=0.048) vs SFC. Adverse events were lower for QVA149 (40.1%) vs SFC (47.4 %). Incidence of pneumonia was lower in QVA149 (0.8%) vs SFC (2.7%).
Conclusion
QVA149 was superior in bronchodilation and rate of exacerbations versus SFC and was similar in pt-reported outcomes. These findings support the use of LABA/LAMA combination over LABA/ICS in moderate-to-severe COPD pts with or without recent exacerbations.
- © 2014 ERS