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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

Detailed Description

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.

Interventions

  • Drug: Bepotastine besilate
    • Two TAU-284 5mg tablets will be taken orally twice a day

Arms, Groups and Cohorts

  • Experimental: TAU-284
    • Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).

Clinical Trial Outcome Measures

Primary Measures

  • Number of Patients With Adverse Events and Adverse Drug Reactions
    • Time Frame: Up to Week 12

Secondary Measures

  • 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.
    • Time Frame: Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point (up to Week 12)
    • 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).
  • Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
    • Time Frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
  • Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
    • Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
  • Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
    • Time Frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
  • Influence of Activities in Daily Life(Study, Outing, Sleeping)
    • Time Frame: 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)
    • Time Frame: Week 12 or suspension

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mitsubishi Tanabe Pharma Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • KIMIHIRO OKUBO, Study Director, Nippon Medical School

Citations Reporting on Results

Okubo K, Ichimura M, Koyama T, Susuta Y, Izaki H. Double-blind placebo-controlled study of bepotastine besilate in pediatric patients with perennial allergic rhinitis. Expert Opin Pharmacother. 2015;16(16):2395-408. doi: 10.1517/14656566.2015.1085511. Epub 2015 Sep 12.

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