Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma

Study Overview
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Brief Summary
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This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.

Detailed Description
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A 12 week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled, 4-arm, Dose finding trial to Assess the Efficacy and Safety of SOTB07 in persistent asthma.

Official Title
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A 12 Week, Multi-center,Randomized, Double Blinded, Parallel Group, Placebo-controlled, 4-arm, Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: SOTB07
* Drug: SOTB07
* Drug: placebo
* Drug: montelukast


Participation Criteria
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Eligibility Criteria
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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) 50% ≤ FEV1 ≤ 85% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours) 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 Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 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 or 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
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Minimum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOTB07 100mg<br> | Drug: SOTB07<br>* SOTB07 100mg<br>|
| Experimental: SOTB07 200mg<br> | Drug: SOTB07<br>* SOTB07 200mg<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* placebo<br>|
| Active Comparator: Montelukast 10mg<br> | Drug: montelukast<br>* montelukast 10mg po, bid, 12week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change from baseline for FEV1 at each visit |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent asthma