The effect of a single dose of formoterol using an aerosol inhaler in asthmatic children. A randomized, controlled, double-blind study

The duration of action of inhaled formoterol, a new long-acting beta-2-agonist, was compared to inhaled salbutamol and placebo in a double-blind, randomized, cross-over study in 16 children (8-12 years old) with stable moderate to serve asthma. Mean baseline FEV1 was 68 +/- 8% predicted. On the 4 study days, baseline FEV1 was within 15% of the FEV1 on visit 1. Two-three days apart, each patient inhaled either placebo, salbutamol (200 micrograms) formoterol (12 or 24 micrograms). FEV1 and PEF were measured repeatedly during 8 and 12 hours respectively. After formoterol, improvement over placebo remained significant at 8 hours for FEV1 (p = 0.006) and 12 hours for PEF (p = 0.01). When compared to salbutamol, it was significant at 8 hours for PEF (p = 0.03). There were no significant differences in lung function when comparing the 12 micrograms and 24 micrograms doses of formoterol. Side-effects were minimal.