Multicentre, randomised, placebo-controlled, double-blind, parallel-group study of patients (N?=?1030) with moderate-to-severe COPD. All medication was administered once daily in the morning. Co-primary efficacy endpoints were: (1) weighted mean (wm) FEV1 (0-4?h post-dose on day 168) to assess acute lung function effects; and (2) trough FEV1 (23-24?h post-dose on day 169) to assess long-lasting effects. Symptom-related outcomes were analysed and adverse events (AEs) assessed.
Main findings were: (1) the combination of FF/VI at a strength of 100/25?¦Ìg significantly (p?<?0.001) improved wm FEV1 (173?ml) and trough FEV1 (115?ml) vs. placebo. Similar effects were observed with FF/VI 50/25?¦Ìg; (2) no significant difference was seen between FF/VI 100/25?¦Ìg and VI 25?¦Ìg for trough FEV1 (48?ml, p?=?0.082), while an effect was observed between FF/VI 100/25?¦Ìg and FF 100?¦Ìg for wm FEV1 (120?ml, p?<?0.001); (3) VI 25?¦Ìg over 24 weeks improved lung function vs. placebo significantly for wm FEV1 (103?ml, p?<?0.001) and trough FEV1 (67?ml, p?=?0.017); and (4) no safety signal was observed.
In subjects with moderate-to-severe COPD, FF/VI 100/25?¦Ìg provides rapid and significant sustained bronchodilation at 24 weeks. Lung function is improved to a similar extent with FF/VI 50/25?¦Ìg and to a somewhat lesser extent with VI 25?¦Ìg. All treatments were well tolerated.
GSK study number: HZC112206.
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