Clinical Trial to Evaluate the Efficacy and Safety of CKD-342

Study Overview
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Brief Summary
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Clinical Trial to Evaluate the Efficacy and Safety of CKD-342

Detailed Description
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A Randomized, Double-blind, Active-controlled, Multicenter phase 3 Clinical trial to evaluate the Efficacy and Safety of Concomitant Mometasone furoate and Levocabastine HCl in Perennial Allergic Rhinitis patients

Official Title
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A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Concomitant Mometasone Furoate and Levocabastine HCl in Perennial Allergic Rhinitis Patients

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: CKD-342
* Drug: Mometasone furoate
* Drug: Levocabastine HCL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male, female, Age: over 13 years(no age limiation in upper) subject who has experienced perennial allergic rhinitis for over 1 year subject who has identified allergens throughout the year within 12 months subject who has the symptoms of moderate to severe allergic rhinitis subject who can record the the patient diary during the clinical trial period subject who agreed to keep the same environment during the clinical trial period Exclusion Criteria: Asthma Previous medical history at screening (Nasal polyps within the previous two months, biopsies, ulcers, trauma, surgery, atrophic rhinitis, patients with a history of drug rhinitis) Patients with untreated localized infection in nasal mucosa Patients following administration of a combination of prohibited drugs in patients administered concomitant medications or trial period is expected to be inevitable Patients with abnormal following laboratory test results at screening AST, ALT>2times the upper limit of normal at screening Serum creatinine >1.5times the upper limit of normal at screening Previous history of acute or severe chronic sinusitis within 30 days at screening The continue use of drugs that may affect the efficacy of the Investigational product Start the immunotherapy or a change of doge within 1 month, at screening If you have glaucoma or cataracts, herpes simplex, or around the eyes Chronic obstructive pulmonary disease (COPD) history of hypersensitivity reactions and for treaties or major components of the IP Pregnant women, breast feeding women or women of childbearing potential must agree to use appropriate contraception methods Alcohol or illegal drug abuse or dependence in patients participation in any investigational or maketed drug within 4weeks preceding the screening visit Patients that can not be participating in a clinical trial by investigator's discretion

Ages Eligible for Study
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Minimum Age: 13 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: Treatment<br>CKD-342 | Drug: CKD-342<br>* treatment for 4 weeks after randomization<br>* Other names: investigational product;|
| Active Comparator: Control 1<br>Mometasone furoate | Drug: Mometasone furoate<br>* treatment for 4 weeks after randomization<br>* Other names: investigational product;|
| Active Comparator: Control 2<br>Levocabastine HCL | Drug: Levocabastine HCL<br>* treatment for 4 weeks after randomization<br>* Other names: investigational product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in rTNSS from baseline |  | up to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in rTNSS from baseline |  | up to week 2 | 
| change in AM rTNSS and PM rTNSS from baseline |  | 2 weeks and 4 weeks after the baseline assessment | 
| Physician assessed overall nasal symptom from baseline |  | 2 weeks and 4 weeks after the basline assessment | 
| change from baseline in RQLQ |  | 2 weeks and 4 weeks after the baseline assessment | 
| Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline |  | 2 weeks and 4 weeks after the basline assessment |