Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral administration of SOTB07 200mg, 400mg, placebo for 12 weeks.

Detailed Description
-----------------
A 12-week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled study to Assess the Efficacy and Safety of SOTB07 in asthma patients

Official Title
-----------------
A 12-week, Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: SOTB07 200mg
* Drug: SOTB07 400mg
* Drug: SOTB 200mg placebo
* Drug: SOTB 400mg placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or eligible female subjects aged 15 years or more A female is eligible if she is of: Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly Negative pregnancy test at screening Non-smoker for at least 1 year, a pack history of ≤ 10 pack years Symptom of persistent asthma, as defined by the National Institute of Health (NIH) 5.50% ≤ FEV1 ≤ 80% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours) 6.FEV1 reversibility ≥ 12% and 200 ml at 20-30 minutes after inhalation of a short acting ß-agonist (Salbutamol 2 puffs; 200㎍) at Visit 1 or within 6 months before Visit 1 7.Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.Appropriately signed and dated informed consent has been obtained Exclusion Criteria: Active upper or lower respiratory tract infection within 3 weeks before visit 1 Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1 Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1 Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma Clinically significant and uncontrolled psychiatric disease history of drug or alcohol abuse Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1 Change of Immunotherapy within 6 months before visit 1 Administration of the antiasthma agent within 1 week of visit 1 Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines Participation in study using an experimental medication within 1 month before visit 1 Other ineligible subject in the opinion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOTB07 200mg<br>One tablet of SOTB07 200mg and One tablet of SOTB 400mg Placebo are administered twice a day. | Drug: SOTB07 200mg<br> <br> Drug: SOTB 400mg placebo<br>* Placebo of SOTB07 400mg<br>|
| Experimental: SOTB07 400mg<br>One tablet of SOTB07 400mg and One tablet of SOTB 200mg Placebo are administered twice a day. | Drug: SOTB07 400mg<br> <br> Drug: SOTB 200mg placebo<br>* Placebo of SOTB07 200mg<br>|
| Placebo Comparator: Placebo<br>One tablet of SOTB 200mg Placebo and One tablet of SOTB 400mg Placebo are administered twice a day. | Drug: SOTB 200mg placebo<br>* Placebo of SOTB07 200mg<br>Drug: SOTB 400mg placebo<br>* Placebo of SOTB07 400mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 change from the baseline |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spirometer parameters |  | 12 weeks | 
| Change in FeNO |  | 12 weeks | 
| Change in AM/PM PEFR |  | 12 weeks | 
| Change in diurnal asthma symptom score |  | 12 weeks | 
| Change in the number of days with experience of nocturnal asthma symptoms |  | 12 weeks | 
| Change in amount of beta-2 agonist used (puff/day) |  | 12 weeks | 
| Proportion of rescue free day |  | 12 weeks | 
| Proportion of asthma control day |  | 12 weeks | 
| Proportion of asthma exacerbation |  | 12 weeks | 
| Proportion of treatment failure (severe asthma exacerbation) |  | 12 weeks | 
| Changes in asthma control questionaire score |  | 12 weeks | 
| Changes in quality of life questionaire for adult korea asthmatics scores |  | 12 weeks | 
| Changes in patient's global self assessment score |  | 12 weeks | 
| Change in visual analogue scale for cough score |  | 12 weeks | 
| Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample |  | 12 weeks | 
| Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample |  | 12 weeks | 
| Assessment of Safety | Adverse Event/ Vital Sign/ Laboratory Test | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, SOTB07