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

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

Official Title
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Efficacy and Safety of HCP1102 in Patients With Perennial Allergic Rhinitis : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: HCP1102
* Drug: HGP1408


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCP1102<br> | Drug: HCP1102<br>* The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.<br>|
| Active Comparator: HGP1408<br> | Drug: HGP1408<br>* The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | base line, 3-4week(2weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | baseline, 3-4week(2weeks) |