Evaluation of oral bronchodilator therapy in asthmatic children

The bronchodilator efficacy of oral ephedrine and theophylline (as aminophylline), separately and combined, was examined in a randomized double-blind study. Week-long trials of five drug regimens were administered every 6 hours to 12 asthmatic children. These regimens included conventional and "high" (approximately twice conventional) doses of the two-drug combination in addition to a placebo and "high" doses of the individual drugs. Efficacy was determined by symptom-medication comparisons and by pulmonary function testing performed three times daily. Adverse drug effects were also recorded and compared. Aminophylline (theophylline ethylenediamine) in "high" doses (mean of 230 or 8.1 mg. per kilogram per dose) resulted in serum theophylline concentrations averaging 13 μg per milliliter and 9μg per milliliter at 2 and 4 hours and was highly effective in relieving signs and symptoms of asthma. The inclusion of ephedrine resulted in no further benefit but did appear to increase the frequency of adverse effects. The lower, more conventional doses of the ephedrine-theophylline combination were ineffective in significantly altering the course of the disease.