A Phase I, Randomized, Open, Multi-center, Cross over study to Evaluate the Therapeutic Equivalence of Repeated Dose of HCP0910 250/50 µg to SeretideTM 250 DiskusTM in Asthmatic Patients
Not Applicable
Completed
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0000396
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
1. BDR test: after Ventolin FEV1 increase 12% and 200mL over
2. Before Ventolin FEV1 > 60%
Exclusion Criteria
1. 10 pack-year smoking history
2. 14 units over/ a week of alcohol or drug abuse
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method After 2 weeks, averge of morning pre dose FEV1
- Secondary Outcome Measures
Name Time Method After 2 weeks, averge of morning pre dose eNO;After 2 weeks, averge of morning pre dose FVC;After 2 weeks, averge of morning pre dose FEV1/FVC;After 2 weeks, averge of morning pre dose FEF25-75%