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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Perennial Allergic Rhinitis; Non-seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: AGR tablet; Drug: Placebo (for AGR tablet and/or Active Comparator); Drug: Active Comparator

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 402-751
    • Inha University Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 156-707
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 137-701
    • Seoul ST. Mary's hospital
  • Seoul, Korea, Republic of, 120-751
    • Severance Hospital
  • Seoul, Korea, Republic of, 130-872
    • Kyung Hee University Medical Center
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AGR & Placebo; AGR tablet by qd and Placebo by bid for 4 weeks	Drug: AGR tablet; Drug: Placebo (for AGR tablet and/or Active Comparator)
PLACEBO_COMPARATOR: Placebo; Placebo by bid for 4 weeks	Drug: Placebo (for AGR tablet and/or Active Comparator)
ACTIVE_COMPARATOR: Active comparator; Active Comparator and Placebo by bid for 4 weeks	Drug: Placebo (for AGR tablet and/or Active Comparator); Drug: Active Comparator

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Collaborators: Samsung Medical Center; Seoul St. Mary's Hospital; Seoul National University Hospital; Seoul National University Bundang Hospital; SMG-SNU Boramae Medical Center; Konkuk University Medical Center; Severance Hospital; Kyunghee University Medical Center; Inha University Hospital
• Investigators: Study Chair: Chae-Seo Rhee, M.D., Seoul National University Bundang Hospital; Principal Investigator: Tae-Bin Won, M.D., Seoul National University Hospital; Principal Investigator: Dae-Woo Kim, M.D., SMG-SNU Boramae Medical Center; Principal Investigator: Hyo-Yeol Kim, M.D., Samsung Medical Center; Principal Investigator: Sung-Wan Kim, M.D., Kyunghee University Medical Center; Principal Investigator: Jin-Kook Kim, M.D., Konkuk University Medical Center; Principal Investigator: Young-Hyo Kim, M.D., Inha University Hospital; Principal Investigator: Soo-Whan Kim, M.D., Seoul ST. Mary's hospital; Principal Investigator: Chang-Hoon Kim, M.D., Severance Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2013
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion: January 1, 2015

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (ESTIMATE): November 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 11, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Allergic Rhinitis; Perennial Allergic Rhinitis; PAR; Non-seasonal Allergic Rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: AGR_P3