None listed
Conditions
Interventions
Drug : Comparator : Placebo bid p.o 6w
Treatment 1 : SA09012 15mg bid p.o 6w
Treatment 2 : SA09012 30mg bid p.o 6w
Sponsors
Sama Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in PEF status(Morning) at week 6 compared to baseline as a function of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in PEF status(night) at week 6 compared to baseline as a function of treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactEsther Ahn
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed