Clinical evaluation of TE-031 in the treatment of paranasal sinusitis

Abstract

The clinical effectiveness, safety, and utility of TE-031 (A-56268) was studied in the treatment of paranasal sinusitis. TE-031 was administered orally to 27 patients with paranasal sinusitis in a daily dose of 200-400mg/day in two divided doses. 26 patients participated in the evaluation of the clinical efficacy of TE-031, 16 of whom suffered from acute sinusitis and 10 with actue exacerbations of chronic sinusitis. The doctor in charge rated the clinical efficacy of the drug at 69.2% (18/26), identical to the drug study committee rating of 69.2% (18/26). A utility rate of 65.4% (17/26) was also reported by the physician in charge. Patients with gram positive bacterial infections experienced a bacteria erradication rate of 87.5% (7/8) and of 83.3% (5/6) in patients with gram negative bacterial infections. No side effects and abnormal laboratory findings were reported in any of the 27 patients involved either during or after the study. Based upon the above results, TE-031 has been demonstrated to be a drug very useful in the treatment of paranasal sinusitis.