Formoterol mono- and combination therapy with tiotropium in patients with COPD: A 6-month study

SummaryAlthough guidelines recommend combining long-acting bronchodilators in COPD, data are limited. We examined the clinical efficacy and safety of formoterol, tiotropium and the combination in patients with COPD.Eight hundred and forty-seven patients with COPD (mean FEV1 52% predicted; FEV1/FVC 53%) were randomized to receive one of the following four treatments for 24weeks: formoterol 10μg b.i.d. plus tiotropium 18μg o.d.; formoterol 10μg b.i.d.; tiotropium 18μg o.d., or placebo. The study was partially blinded (formoterol and placebo).For the primary endpoint, FEV1 2h post-dose after 24weeks, there were small differences in favour of the combination therapy versus formoterol (0.07L, p=0.044) or tiotropium (0.06L, p=0.066). All three treatments were superior to placebo (p<0.001). The combination was statistically superior to monotherapy for: the primary endpoint (p=0.044 vs. formoterol); FEV1 5min after the first dose (p<0.001) and at 12weeks (p<0.05 vs. tiotropium); and peak expiratory flow averaged over the first 6weeks (p