Objective: This study evaluated the efficacy and safety of the formoterol Turbuhaler® at dosages of 4.5, 9 and 18 μg bid compared with placebo in Japanese patients with COPD. Methods: In this randomized, double-blind, placebo-controlled, multicenter study, 36 patients with a prebronchodilator FEV1 value within 40 to 70% of the predicted value were randomized to receive formoterol at doses of 4.5, 9, and 18 μg bid, and placebo, for 1 week in a crossover fashion. Results: The primary outcome variable, one hour post-dose FEV1 on the last day of the one week treatment period, was significantly higher for all formoterol dosages compared with placebo (p<0.001 for all doses); adjusted g-means for formoterol 4.5, 9 and 18 μg bid, and placebo, were 1.510 L, 1.491 L, 1.520 L and 1.342 L, respectively. All three dosages of formoterol also provided significantly better improvements than placebo in the secondary variables FVC, inspiratory capacity (IC) and morning and evening PEF. Results for IC and PEF indicated a trend towards a larger improvement at higher dosages. Conclusion: Treatment with formoterol at dosages of 4.5, 9 and 18 μg bid showed significantly superior effects to placebo on FEV1 in Japanese patients with COPD. The results for some of the secondary variables (IC and PEF) indicated a trend towards larger improvements at higher dosages. All dosages of formoterol were well tolerated in Japanese patients.
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