Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis

Hanmi Pharmaceutical Company Limited174 enrolled

Overview

Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

174

Conditions

Perennial Allergic Rhinitis

Interventions

HCP1102DRUG

The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.

HGP1408DRUG

The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with at least 2 years history of PAR prior to the study * Positive results of skin prick test * Patients who provided a signed written informed consent form * Patients who are able and willing to complete subject diaries * Patients who agree to maintain consistency in their surroundings throughout the study period Exclusion Criteria: * Patients also with non-allergic rhinitis with different causes. * Patients with severe asthma. * History of acute • chronic sinusitis within 1 month of Visit 1 * History of intranasal surgeries within 3 months of Visit 1 * Initiation of immunotherapy or dose modification within 1 month prior to Visit 1 * Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1. * Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.

Locations (1)

Gangnam Severance Hospital.

Seoul, South Korea

Outcomes

Primary Outcomes

Change of Mean Daytime Nasal Symptom Score

Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe).

Time frame: base line, 3-4week(2weeks)

Secondary Outcomes

Change of Mean Nighttime Nasal Symptom Score

Nighttime nasal symptoms included nasal obstruction awakening (0 = none; 1 = mild; 2 = moderate; 3 = severe), difficulty getting to sleep (0 = not at all; 1 = little; 2 = moderate; 3 = severe), and nighttime awakening (0 = not at all; 1 = once; 2 = more than once; 3 = awake all night).

Time frame: baseline, 3-4week(2weeks)

Data from ClinicalTrials.gov

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