Safety and Efficacy of SA09012 in Asthma

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SamA Pharmaceutical Co., Ltd

Criteria

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