| Abstrakt: |
We aimed to compare the protective effect of single doses of 4.5 and 9 microg of formoterol fumarate (F), 0.5 mg terbutaline sulphate (T) and placebo (P), all via Turbuhaler, against exercise-induced bronchoconstriction (EIB) in children. Twenty-seven asthmatic children, showing a fall of > or =20% in FEV1 after a standardized exercise challenge test (ECT) combined with cold air (-10 degrees C) inhalation, were randomized in this cross-over, double-blind study. They had a mean age of 12.6 years (range 8-17 years), mean baseline FEV1 90% (73.9-105.6%) of predicted normal value. Seventeen children used inhaled glucocorticosteroids (120-750 microg day(-1)). ECTs were performed 15 min and 4, 8, and 12 h after drug administration. F significantly reduced the fall in FEV1 after ECT to 5.4% (15 min), 5.2% (4 h), 8.2% (8 h) and 9.3% (12 h) after 4.5 microg, and 2.5%, 3.0%, 5.0% and 5.4% after 9 microg, compared with a fall of 18.4%, 15.7%, 15.6% and 16.5% in FEV1 after P. The fall after T was 3.3%, 11.6%, 14.4% and 19.1% after 15 min, 4, 8 and 12 h respectively. The difference between F and T was statistically significant from 4 h and onward (P-value for all comparisons < 0.05). Children using a single dose of either formoterol Turbuhaler 4.5 or 9 microg had significantly better bronchoprotection against repeated exercise challenge up to 12 h compared with placebo and from 4 h onward compared with terbutaline Turbuhaler 0.5 mg. |
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