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

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.

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