A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

Inclusion Criteria:

• Patients aged between 7 and 15 years
• Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
• Patients with a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 3 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.

Exclusion Criteria:

• Patients with vasomotor rhinitis or eosinophilic rhinitis
• Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
• Patients with a history of any of the nasal surgical procedures
• Patients with current or previous history of drug allergy
• Patients who concurrently have renal function abnormalities that may cause safety problems etc.