Therapeutic efficacy of a new anhydrous theophylline dosage form.

A clinical study was performed on 41 asthmatic patients. After complete physical and spirometric examinations, they received capsules containing 200 mg anhydrous theophylline per capsule t.i.d. for three weeks. All other antiasthmatic medications were omitted during this study. The results showed that these capsules (Elixophyllin Capsules) produced statistically significant improvement in wheezing, dyspnea, global clinical assessment, vital capacity, and forced expiratory volume at 1 second. Side effects, which were generally mild and transient, were those usually reported for theophylline and were observed in 11 of the 41 patients. One patient dropped out of the study because of extreme nausea. It was concluded that theophylline as a single entity can provide significant improvement in asthmatic patients at a total daily dose of 600 mg.