[Formoterol as inhalation powder in the treatment of patients with reversible obstructive lung diseases. A 3-month placebo-controlled comparison of the effects of formoterol and salbutamol, followed by a 12-month period with formoterol alone]

Abstract

This article is based on a study first published in Allergy. The bronchodilating effect of the long acting beta 2-agonist formoterol dey powder (dp) 12 micrograms twice daily was compared to salbutamol 400 micrograms four times daily and placebo in patients with reversible obstructive airway disease. The study design consisted of a closed 12-week double-blind, placebo-controlled, multicentre trial followed by an open noncomparative, multicentre 12-month follow-up trial, in which tolerability of formoterol dp was assessed. A total of 304 patients aged 18-79 years were randomized. The bronchodilating effect of formoterol, assessed by morning premedication peak flow rate, was significantly superior to placebo (p < 0.0001) and salbutamol (p < 0.001). Efficacy was maintained during the open follow-up study. Formoterol 12 micrograms twice daily significantly reduced morning and evening asthma symptoms and sleep disturbances, and significantly reduced the need for rescue medication. In conclusion, formoterol 12 micrograms dp twice daily was significantly superior to both salbutamol 400 micrograms dp four times daily and placebo, and reduced asthma symptoms significantly. Overall, formoterol showed a tolerability profile comparable to that of salbutamol, and no tachyphylaxis was observed during one year of treatment.