Status:
COMPLETED
Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Asthma
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.
Eligibility Criteria
Inclusion
- age 20 \~ 75 inclusive
- Asthmatic diagnosis in more than 12 weeks from screening day
- Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2
Exclusion
- Maintain controlled asthma for more than 4 weeks before screening
- Diagnosed as a severe asthmatic patients
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01521455
Start Date
February 1 2012
End Date
July 1 2013
Last Update
August 23 2013
Active Locations (7)
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1
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyunggi -do, South Korea
2
Ajou University Hospital
Suwon, Gyunggi -do, South Korea
3
Asan Medical Center
Seoul, South Korea
4
Ewha Womans University Medical Center
Seoul, South Korea