Efficacy and safety of formoterol in Japanese patients with COPD.
OBJECTIVE
This study evaluated the efficacy and safety of the formoterol Turbuhaler at dosages of 4.5, 9 and 18 microg bid compared with placebo in Japanese patients with COPD.


METHODS
In this randomized, double-blind, placebo-controlled, multicenter study, 36 patients with a pre-bronchodilator FEV(1) value within 40 to 70% of the predicted value were randomized to receive formoterol at doses of 4.5, 9, and 18 microg bid, and placebo, for 1 week in a crossover fashion.


RESULTS
The primary outcome variable, one hour post-dose FEV(1) 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 microg 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.


CONCLUSIONS
Treatment with formoterol at dosages of 4.5, 9 and 18 microg bid showed significantly superior effects to placebo on FEV(1) 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.
Minakata
Yoshiaki
Y
The Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan. masakazu@wakayama-med.ac.jp
Iijima
Hideya
H
Takahashi
Tsuneyuki
T
Miura
Motohiko
M
Ogawa
Hiromasa
H
Kimura
Keiji
K
Koga
Takeharu
T
Kinoshita
Masaharu
M
Tsuda
Tohru
T
Aizawa
Hisamichi
H
Ichinose
Masakazu
M
D000318:Adrenergic beta-Agonists / Q000627:therapeutic use*; D000368:Aged; D004311:Double-Blind Method; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D007564:Japan; D008297:Male; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*
D000318:Adrenergic beta-Agonists; D004983:Ethanolamines; D000068759:Formoterol Fumarate