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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: Bepotastine besilate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU-284<br>Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed). | Drug: Bepotastine besilate<br>* Two TAU-284 5mg tablets will be taken orally twice a day<br>* Other names: TALION 5mg tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Events and Adverse Drug Reactions |  | Up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. | Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe). | Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12） | 
| Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) |  | baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 | 
| Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) |  | Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 | 
| Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis |  | baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 | 
| Influence of Activities in Daily Life(Study, Outing, Sleeping) |  | Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 | 
| Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing) |  | Week 12 or suspension | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists, children