Clinical Trial to Evaluate the Safety and Efficacy of CITUS Dry Syrup in Children With Perennial Allergic Rhinitis

Study Overview
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Brief Summary
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Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of CITUS Dry Syrup in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study.

Official Title
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Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of CITUS Dry Syrup in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: CITUS Dry Syrup
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged over 24 months and under 15 years. Patients who was diagnosed with perennial allergic rhinitis by ImmunoCAP test. NIS mean total score of 1-week in baseline should be over 4.0. Exclusion Criteria: Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as pneumonia, cystic fibrosis, viral influenza, tuberculosis, asthma(status praesens). Patient who has cancer, diabetes mellitus, hypertension, CNS disease, and metabolic disease which need medication. Patient who has rhinitis not caused by allergy. Acute or chronic sinusitis. Patient who has medical history of allergy in seasonal pollen during the trial. Patient who has had eyes or nose surgery within 3 months prior to the trial. Patient who has had eye or upper airway infection within 1 week prior to the treatment period. Beginning immunotherapy or dose of change within 1 month prior to the trial. Patient who has clinical history of sensitivity to allergic rhinitis medication. Patient whose heart function is abnormal: including heart failure, abnormal ECG test value that is clinically significant. Patient who has experience to have participated in other clinical trial within 2 months prior to the trial. Patient who has taken contraindicated medications in this study within 1 week(baseline period) prior to the treatment period. For girl who had her first period, result of pregnancy test was positive.

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CITUS Dry Syrup<br>Pranlukast dry syrup 10% | Drug: CITUS Dry Syrup<br>* Pranlukast 10% dry syrup, b.i.d.<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo dry syrup, b.i.d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period | Evaluation : from baseline(1-week prior to treatment)over the 4-week treatment(1-week prior to patients' last visit). NIS : Sum of 4 individual scores for Nasal congestion, Rhinorrhea, Sneezing, and Nasal itching, each rated by patients daily on a 4-point scale [Score 0(best) to 3(worst)]. | 4 week treatment period (from baseline through the end of week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing improvement of symptom by physician |  | from baseline through the end of week 4 | 
| Assessing improvement of symptom by patient |  | from baseline through the end of week 4 | 
| Mean change of Individual NIS |  | from baseline through the end of week 4 | 
| Ratio distribution of NIS at end of week 4 | Percentage of each NIS score. | from baseline through the end of week 4 | 
| Cure rate |  | from baseline through the end of week 4 | 
| Cure rate for each symptom |  | from baseline through the end of week 4 | 
| Use of rescue medication |  | from baseline through the end of week 4 | 
| Change of Instantaneous NIS |  | from baseline through the end of week 4 |