Mild to Moderate Bronchial Asthma
Conditions
Keywords
Asthma
Brief summary
Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
Interventions
DRUGSA09012 Low dose
Tablet, b.i.d
DRUGSA09012 High dose
Tablet, b.i.d
DRUGPlacebo
Tablet, b.i.d
Sponsors
SamA Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline of PEF(Peak Expiratory Flow)at week 6 | 6 week treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in FEV1 at week 6 | 6 week treatment period |
| Mean change from baseline in ACT(Asthma Control Test) at week 6 | 6 week treatment period |
| Safety assessment(Comparison of the adverse event profiles throughout the course of the study) | 6 week treatment period |
Countries
South Korea
Outcome results
None listed