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

Ahn-Gook Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis; Allergic Rhinitis; Non-seasonal Allergic Rhinitis

Treatments: Drug: AGR tablet; Drug: Placebo (for AGR tablet and/or Active Comparator); Drug: Active Comparator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01982916

AGR_P3

Details and patient eligibility

About

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

Enrollment: 324 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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324 participants in 3 patient groups, including a placebo group

AGR & Placebo

Experimental group

Description:

AGR tablet by qd and Placebo by bid for 4 weeks

Treatment:

Drug: AGR tablet

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

Placebo

Placebo Comparator group

Description:

Placebo by bid for 4 weeks

Treatment:

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

Active comparator

Active Comparator group

Description:

Active Comparator and Placebo by bid for 4 weeks

Treatment:

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

Drug: Active Comparator