Safety and Efficacy of WIN-901X in Asthma

Study Overview
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Brief Summary
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This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.

Detailed Description
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Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients

Official Title
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Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: WIN-901X dose level 1
* Drug: WIN-901X dose level 2
* Drug: WIN-901X dose level 3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than or equal to 20 and less than 80 years of age Have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening FEV1 between 60% and 85% before inhaling fast-acting bronchodilator at screening No history of smoking at least one year prior to the screening Having voluntarily signed an informed consent Exclusion Criteria: Have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening Have been hospitalized due to an acute worsening of asthma within 3 months before the screening Have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening Have malignant tumor

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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 1<br> | Drug: WIN-901X dose level 1<br>* 100mg Bid, PO, 12weeks<br>|
| Experimental: Treatment 2<br> | Drug: WIN-901X dose level 2<br>* 200mg Bid, PO, 12weeks<br>|
| Experimental: Treatment 3<br> | Drug: WIN-901X dose level 3<br>* 300mg Bid, PO, 12weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Bid, PO, 12weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the change of FEV1% to the baseline after the medication | FEV1: Forced Expiratory Volume In One Second | Baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the change of ACQ to the baseline after the medication | ACQ: Asthma Control Questionnaire | Baseline, week 12 | 
| Ratio of the date, where no rescue drug was used, during the trial |  | Baseline, week 12 | 
| Ratio of symptom free days during the trial |  | Baseline, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases