Safety and Efficacy of YHD001 in Asthma

Study Overview
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Brief Summary
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The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma. The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.

Detailed Description
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Singulair: Montelukast sodium (leukotriene modulator)

Official Title
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Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 Following 8 Weeks Oral Administration of YHD001 in Patients With Partially Controlled Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: YHD001 dose level 1
* Drug: YHD001 dose level 2
* Drug: Singulair
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed written informed consent Acceptable medical history, physical exam,laboratory tests and EKG, during screening Nonsmoking (for longer than 1 year) patients with asthma Reversible airways obstruction (an increase in FEV1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist FEV1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours) Exclusion Criteria: History of any clinically significant disease History of drug/chemical/alcohol abuse Active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit

Ages Eligible for Study
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Minimum Age: 20 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: YHD001 dose level 1<br> | Drug: YHD001 dose level 1<br>* Tablet, three times daily / 8 weeks<br>|
| Experimental: YHD001 dose level 2<br> | Drug: YHD001 dose level 2<br>* Tablet, three times daily / 8 weeks<br>|
| Active Comparator: Singulair<br> | Drug: Singulair<br>* Tablet, one times daily / 8 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Tablet, one times daily / 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of FEV1 at week 4 | FEV1: Forced Expiratory Volume In One Second | Baseline, week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of FEV1 at week 8 |  | Baseline, week 8 | 
| Change from baseline of PEFR at week 8 | PEFR: Peak Expiratory Flow Rate | Baseline, week 8 | 
| Change from baseline of ACT Score at week 8 | ACT: Asthma control test | Baseline, week 8 | 
| Change from baseline of using rescue medication(b-Agonist) at week 8 |  | Baseline, week 8 | 
| safety assessment | Comparison of the adverse event profiles throughout the course of the study | week 9 |