Rapid onset of bronchodilation in COPD: a placebo-controlled study comparing formoterol (Foradil (R) Aerolizer (TM)) with salbutamol (Ventodisk (TM))

Formoterol fumarate is a beta (2)-agonist bronchodilator that combines a fa st onset of action with along duration of action. Its fast onset of action is well documented in asthma but has not been directly compared with that o f salbutamol in patients with chronic obstructive pulmonary disease (COPD). This randomized, double-blind, placebo-controlled study was conducted to a ssess the bronchodilatory effects over the first 3 h after inhalation of si ngle doses of formoterol 24 mug delivered via the Aerolizer(TM) dry powder inhaler device (double-blind), or salbutamol 400 mug delivered via Diskhale r(R) dry powder inhaler (single-blind) in patients with COPD. A total of 24 patients with COPD were randomized [mean age 61.6 +/- 7.8 years, mean forc ed expiratory volume in 1 sec (FEV1) 1.38+/-0.32 l and 45.8 +/- 9.6% of pre dicted]. Inhalation of formoterol or salbutamol resulted in similar increas es in FEV1 from 0 to 3 h post-dose. Both drugs produced similar bronchodila tion by 5 min, which became almost maximal by 30 min. The primary efficacy variable, the area under the curve (AUC) of the FEV1 increase above predose baseline from 0 to 30 min (AUC(0-30 min)), demonstrated significant effect s for formoterol (mean 5.89 +/- 4.67 l min(-1)), and salbutamol (mean 6.06 +/- 4.34 l min(-1)), which were not statistically different from each other but statistically significantly higher (P < 0.0001) than that observed wit h placebo (-0.32 +/- 2.59 l min(-1)). In addition, both formoterol and salb utamol produced similar and rapid increases in forced vital capacity (FVC). In summary, this study confirms the rapid onset of action of formoterol an d indicates that the onset of action of formoterol and salbutamol are simil ar in patients with COPD. (C) 2001 Harcourt Publishers Ltd.