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

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

Official Title
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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

Conditions
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Allergic Rhinitis, Perennial Allergic Rhinitis, Non-seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: AGR tablet
* Drug: Placebo (for AGR tablet and/or Active Comparator)
* Drug: Active Comparator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGR & Placebo<br>AGR tablet by qd and Placebo by bid for 4 weeks | Drug: AGR tablet<br> <br> Drug: Placebo (for AGR tablet and/or Active Comparator)<br> <br> |
| Placebo Comparator: Placebo<br>Placebo by bid for 4 weeks | Drug: Placebo (for AGR tablet and/or Active Comparator)<br> <br> |
| Active Comparator: Active comparator<br>Active Comparator and Placebo by bid for 4 weeks | Drug: Placebo (for AGR tablet and/or Active Comparator)<br> <br> Drug: Active Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of 4NTSS(4 Nasal Total Symptoms score) from baseline |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic Rhinitis, Perennial Allergic Rhinitis, Non-seasonal Allergic Rhinitis, PAR