Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients
NCT ID: NCT01521455
Last Updated: 2013-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2012-02-29
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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HCP0910
Fluticasone /salmeterol 250/50 combination capsule
HCP0910
250/50, BID for 2 weeks
Seretide Diskus
Seretide 250 Diskus
Seretide Diskus
250/50, BID for 2 weeks
Interventions
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HCP0910
250/50, BID for 2 weeks
Seretide Diskus
250/50, BID for 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Diagnosed as a severe asthmatic patients
20 Years
75 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Kyung-mi Park, Ph.D
Role: STUDY_DIRECTOR
Hanmi Pharmaceutical Co.
Locations
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Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyunggi -do, South Korea
Ajou University Hospital
Suwon, Gyunggi -do, South Korea
Asan Medical Center
Seoul, , South Korea
Ewha Womans University Medical Center
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Samsung medical center
Seoul, , South Korea
Seoul National University
Seoul, , South Korea
Countries
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Other Identifiers
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HM-FTOL-101
Identifier Type: -
Identifier Source: org_study_id