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

Exclusion Criteria

• •1. Active upper or lower respiratory tract infection within 3 weeks before visit 1
• •2. Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1
• •3. Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1
• •4. Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease
• •5. Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma
• •6. Clinically significant and uncontrolled psychiatric disease
• •7. history of drug or alcohol abuse
• •8. Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1
• •9. Change of Immunotherapy within 6 months before visit 1
• •10. Administration of the antiasthma agent within 1 week of visit 1
• •11. Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines
• •12. Participation in study using an experimental medication within 1 month before visit 1
• •13. Other ineligible subject in the opinion of the investigator