Safety and Efficacy of SA09012 in Asthma

SamA Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Mild to Moderate Bronchial Asthma

Treatments: Drug: SA09012 Low dose; Drug: SA09012 High dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01740986

SA09012-P2

Details and patient eligibility

About

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

Enrollment: 225 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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225 participants in 3 patient groups, including a placebo group

SA09012 Low dose

Experimental group

Treatment:

Drug: SA09012 Low dose

SA09012 High dose

Experimental group

Treatment:

Drug: SA09012 High dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo