Clinical Trial to Evaluate the Safety and Efficacy of AGR Tablet as a Treatment of Perennial Allergic Rhinitis in Korean

A 4 Week Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of AGR Tablet in the Treatment of Perennial Allergic Rhinitis in Korean : a Phase III Clinical Trial Bridging Study

The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean patients with AGR tablet.

Inclusion Criteria

• Males or Females no younger than 12 years.
• Patient with a history of perennial allergic rhinitis for at least an year.
• Patient with a positive prick test performed on the same day or within one year before the inclusion date.Patients had to have a (+) prick test for some allergen responsible for non-seasonal rhinitis.
• Patients with a total symptom score before the study of 5 or greater for nasal symptoms only, assessed during inclusion visit.
• Patients able to attend the required number of visits.
• A normal ECG.

Exclusion Criteria

• Patients with non-allergic rhinitis.
• Patients with obstructive nasal polyps or significant deviation of nasal septum in the investigator's criterion.
• Known hypersensitivity to tested drugs(or similar structure) or any components of the tested drugs.
• Asthmatic patients who had experienced an acute clinical attack in the three months previous to the inclusion or who had received or were receiving any type of drug for its prevention or treatment.
• Patients receiving desensitization treatment for any perennial allergen at the inclusion time. However, inclusion of subject stopping this treatment during the study period was permitted.
• Failure to pass properly the washout period of the following period.