Safety and Efficacy of SA09012 in Asthma

Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients

Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients

Inclusion Criteria:

• Diagnosis or presence of asthma within 3 months of the prestudy visit

  1. Increase in PEF ≥ 20% or ≥ 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
  2. Increase in FEV1 ≥ 12% and ≥ 200mL from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit

• FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit

• Having signed an informed consent

Exclusion Criteria:

• Patient who has severe asthma
• Patient who has any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study other protocol-defined inclusion/exclusion criteria may apply
• Patient with an AST or ALT > 2x ULN (upper limit of normal) in the screening visit
• Patient with more than 10 pack year of cigarettes history