GlaxoSmithKline and Innoviva say their combination lung therapy Anoro Ellipta has come out on top in a trial pitting its effectiveness in improving lung function against that of Boehringer Ingelheim’s Spiolto Respimat.
The groups released data showing that the primary endpoint for the eight-week, open-label, cross-over study of 236 patients with COPD was met, in that non-inferiority of Anoro Ellipta (umeclidinium/vilantero; UMEC/VI) compared to Spiolto Respimat (tiotropium/olodaterol; TIO/OLO) in improving lung function, as measured by trough FEV1 (Forced Expiratory Volume in 1 second) at week eight, was shown.
Moreover, UMEC/VI actually demonstrated a superior effect to TIO/OLO, with a difference in treatment effect of 52mL on trough FEV1 at week eight (UMEC/VI 180mL vs. TIO/OLO 128mL), the firms highlighted.
On the safety side, both treatments were comparable in tolerability with an overall incidence of on-treatment adverse events of 25 percent in the UMEC/VI group and 31 percent in the TIO/OLO group. The most frequently-reported were upper respiratory tract infections (UMEC/VI 8 percent; TIO/OLO 9 percent), cough (UMEC/VI 1 percent; TIO/OLO 1 percent) and diarrhoea (UMEC/VI 1 percent; TIO/OLO 1 percent).
“Improving lung function is a clear goal in patients with COPD,” said Eric Dube, senior vice president, head of Global Respiratory, GSK. “The challenge for healthcare professionals to date has been the lack of differentiation within the LAMA/LABA class. That is why we have conducted this study, as the first in-class head-to-head comparison of two fixed-dose once-daily LAMA/LABAs. These data demonstrate that UMEC/VI provides superior lung function improvements to the comparator TIO/OLO.”
In a statement emailed to PharmaTimes, Boehringer Ingelheim said: "This single, open label, crossover study in a limited population cannot be translated into clinically meaningful outcomes, including lung function, symptom improvement or quality of life.
It is speculative to draw any conclusions from the outcomes reported. Additional studies are needed to corroborate these results before making or changing any treatment decisions.
The body of evidence should be considered when comparing the benefits provided by both therapies. We appreciate every effort conducted in the field of respiratory research, as new study results broaden our knowledge about COPD management."