Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0000571
- Lead Sponsor
- Sama Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 234
1. 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
2. FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit
3. Having signed an informed consent
1. Emergency room treatment for asthma within 4 weeks of the prestudy visit
2. Hospitalization for asthma within 8 weeks of the prestudy visit
3. patients with severe asthma
4. Patients with 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
5. history of drug or chronic alcohol abuse
6. Participation in another clinical trial in the past 4 weeks
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in PEF status(Morning) at week 6 compared to baseline as a function of treatment
- Secondary Outcome Measures
Name Time Method Mean change in PEF status(night) at week 6 compared to baseline as a function of treatment