The efficacy and safety of E-0659 were studied in 40 patients with perennial allergic rhinitis at 6 institutions after a long term (max. 8 weeks) administration. The test article was 0.2% granules of E-0659 in each wrapper, containing 1 mg of E-0659. It was administered orally in a dose of 1 mg twice daily for 2 to 8 weeks. When moderate to remarkable responses were taken into account, the rate of effectiveness was 60%, and when slight to remarkable responses were taken into account, the rate of effectiveness was as high as 90%. In the evaluation of the usefulness of E-0659, it was judged to be moderately to highly useful in 57.5% of patients or slightly to highly useful in 90% of patients. Adequate improvements in both subjective and objective symptoms were noted at least within the 2 th week of treatment, and an inhibitory effect persisted throughout the treatment period. Side effects were noted in 5 patients (12.5%), but all symptoms of side effects were mild and transient. After 8 weeks of treatment with E-0659, it was shown to have an adequate inhibitory effect on perennial allergic rhinitis and an adequate margin of safety.
