Twenty-four patients with reversible airflow obstruction under suboptimal control on conventional therapy entered a double-blind placebo-controlled trial of additional oral sustained release aminophylline. Assessment was by diary cards, twice daily PEFR, and weekly FEV1. Nineteen patients completed the trial satisfactorily. Eleven were improved subjectively by addition of aminophylline. The mean PEFR for all 19 patients rose from 232 1 min-1 SEM +/- 5, to 247 1 min-1 SEM +/- 4 (p less than 0.0001); nine individuals showed a statistically significant improvement in mean PEFR and 10 showed an improvement of greater than 200 ml in their FEV1. Improvement in PEFR on aminophylline was not at the expense of benefit from inhaled salbutamol. Unwanted effects of nausea, headache, and abdominal discomfort were recorded by 12 of the 24 patients entering the trial. Seventeen of the 19 patients completing the trial had plasma theophylline levels in the accepted therapeutic range of 10-20 mg 1(-1). The drug doses required to achieve these levels varied from 8.6-30.8 mg kg-1 24 hr-1 in the patients with no clinical or biochemical evidence of liver disease. Oral aminophylline can improve control of airflow obstruction in patients with moderately severe disease who are already receiving multiple medication, but side-effects often limit its use. The wide dose range required to achieve therapeutic plasma levels indicates that measurements of plasma theophylline are necessary for adequate interpretation of trials of theophylline compounds.
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